fixný rozsah akreditácie - ...2 z 13 príloha k rozhodnutiu č. 152/8076/2019/1 a k osvedčeniu o...
TRANSCRIPT
1 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Fixnyacute rozsah akreditaacutecie
Naacutezov akreditovaneacuteho subjektu Onkologickyacute uacutestav sv Alžbety sro
Heydukova 10 812 50 Bratislava
Uacutestav laboratoacuternej mediciacuteny SZU a OUacuteSA
Oddelenie klinickej biocheacutemie
Oddelenie imunodiagnostiky
Oddelenie hematoloacutegie a transfuzioloacutegie
Oddelenie klinickej imunoloacutegie a alergoloacutegie
Uacutestav patoloacutegie SZU a OUacuteSA
Oddelenie klinickej patoloacutegie a cytoloacutegie
Oddelenie klinickej biocheacutemie ndashOKB Uacutestav laboratoacuternej mediciacuteny SZU a OUacuteSA
Polo
žka
Objekt skuacutešky Zavedenaacute metoacuteda
Ostatneacute
špecifikaacutecie Systeacutem
Biologickyacute
materiaacutel
Analyt
Ukazovateľ
Princiacutep
Druh
Typ
Označenie
1 seacuterum Glukoacuteza (GLU) Spektrofotometria
Beckman Coulter ndash Glukose
(SPP OKB 1) Hexokinaacutezovaacute metoacuteda (HK)
2 seacuterum Močovina (UREA) Spektrofotometria
Beckman Coulter ndash Urea
(ŠPP OKB 2)
Enzyacutemovaacute metoacuteda
Ureaacuteza GLDH
3
seacuterum Kreatiniacuten (KREA) Spektrofotometria
Beckman Coulter ndash Creatinine
Enz
(ŠPP OKB 3)
Enzymatickaacute metoacuteda
4
seacuterum Kyselina močovaacute (KM) Spektrofotometria Beckman Coulter ndash Uric Acid
(ŠPP OKB 4)
Enzyacutemovaacute metoacuteda
UrikaacutezaPOD s
Askorbaacutetoxidaacutezou
5 seacuterum
Bielkoviny celkoveacute (CB) Spektrofotometria
Beckman Coulter ndash Total
Protein
(ŠPP OKB 5)
Biuretovaacute metoacuteda
6
seacuterum Albumiacuten (ALB) Spektrofotometria
Beckman Coulter ndash Albunin
(ŠPP OKB 6) Broacutemkrezolovaacute zeleň (BCG)
7 seacuterum Bilirubiacuten celkovyacute (BILT) Spektrofotometria
Biolatest BIL T DCA L500
(ŠPP OKB 7) Metoacuteda s DCA
8
seacuterum
Aspartaacutet-amino-
transferaacuteza (AST) Spektrofotometria
Beckman Coulter ndash AST
(ŠPP OKB 8)
IFCC (TRIS 37degC)
modifikovanaacute metoacuteda bez PLP
9
seacuterum
Alanin-amino-transferaacuteza
(ALT) Spektrofotometria
Beckman Coulter ndash ALT
(ŠPP OKB 9)
IFCC (TRIS 37degC)
modifikovanaacute metoacuteda bez PLP
10 seacuterum
Gama-glutamyl-
transferaacuteza (GMT) Spektrofotometria
Beckman Coulter ndash GGT
(ŠPP OKB 10) IFCC (37degC) metoacuteda
11
seacuterum
Alkalickaacute fosfataacuteza (ALP) Spektrofotometria
Beckman Coulter ndash ALP
(ŠPP OKB 11)
IFCC metoacuteda (AMP pufer
37degC)
12
seacuterum
Cholesterol (CHOL) Spektrofotometria
Beckman Coulter ndash Cholesterol
(ŠPP OKB 12)
Enzyacutemovaacute metoacuteda
CHODPOD 4-aminoantipyrin
13
seacuterum
Triacylglyceridy (TAG) Spektrofotometria
Beckman Coulter ndash
Triglyceride
(ŠPP OKB 13)
Enzyacutemovaacute metoacuteda GPO POD
14
seacuterum
Sodiacutek (NA)
Nepriama
potenciometria
Beckman Coulter ndash ISE
Reagents
(ŠPP OKB 14)
ISE metoacuteda
15
seacuterum
Drasliacutek (K)
Nepriama
potenciometria
Beckman Coulter ndash ISE
Reagents
(ŠPP OKB 15)
ISE metoacuteda
16
seacuterum
Chloridy (CL)
Nepriama
potenciometria
Beckman Coulter ndash ISE
Reagents
(ŠPP OKB 16)
ISE metoacuteda
17
seacuterum
Vaacutepnik (CA) Spektrofotometria
Beckman Coulter Calcium
Arsenazo
(ŠPP OKB 17)
Metoacuteda s Arsenazo
2 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Polo
žka
Objekt skuacutešky Zavedenaacute metoacuteda
Ostatneacute
špecifikaacutecie Systeacutem
Biologickyacute
materiaacutel
Analyt
Ukazovateľ
Princiacutep
Druh
Typ
Označenie
18 seacuterum
Fosfor (P) Spektrofotometria
Beckman Coulter ndash Inorg
Phosphor
(ŠPP OKB 18)
UV-molybdaacutetovaacute metoacuteda
19
seacuterum
Horčiacutek (MG) Spektrofotometria
Beckman Coulter ndash
Magnesium
(SPP OKB 19)
Xylidylovaacute modraacute
20
seacuterum
Železo (FE) Spektrofotometria
Beckman Coulter ndash Iron
(ŠPP OKB 20) Metoacuteda s TPTZ
21
seacuterum
Laktaacutetdehydrogenaacuteza
(LDH) Spektrofotometria
Beckman Coulter ndash LD
(ŠPP OKB 21) IFCC metoacuteda (37degC LrarrP)
22 seacuterum
Kreatiacutenkinaacuteza (CK) Spektrofotometria
Beckman Coulter ndash CK (NAC)
(ŠPP OKB 22) IFCC metoacuteda (NAC 37degC)
23 seacuterum
Amylaacuteza (AMS) Spektrofotometria
Beckman Coulter ndash α-Amylase
(ŠPP OKB 23)
IFCC metoacuteda ( ethyliden-
G7PNP)
24 seacuterum
Imunoglobuliacuten G (IGG) Imunoturbidimetria
Beckman Coulter ndash IgG
(ŠPP OKB 24)
25 seacuterum
Imunoglobuliacuten A (IGA) Imunoturbidimetria
Beckman Coulter ndash IgA
(ŠPP OKB 25)
26 seacuterum
Imunoglobuliacuten M (IGM) Imunoturbidimetria
Beckman Coulter ndash IgM
(ŠPP OKB 26)
27 seacuterum
C-reaktiacutevny proteiacuten
(CRP) Imunoturbidimetria
Beckman Coulter ndash CRP Latex
(ŠPP OKB 27) Latex
28 seacuterum
Komplement C3 (C3) Imunoturbidimetria
Beckman Coulter ndash C3
(ŠPP OKB 30)
29 seacuterum
Komplement C4 (C4) Imunoturbidimetria
Beckman Coulter ndash C4
(ŠPP OKB 31)
30 seacuterum
Folaacutet (FOL)
Chemilumini-
scenčnaacute
imunoanalyacuteza
Beckman Coulter ndash FOLATE
(ŠPP OKB 32)
31 seacuterum
Vitamiacuten B12 (VITB12)
Chemilumini-
scenčnaacute
imunoanalyacuteza
Beckman Coulter ndash VITAMIN
B12
(ŠPP OKB 33)
32 seacuterum
Cortizol (CORT)
Chemilumini-
scenčnaacute
imunoanalyacuteza
Beckman Coulter ndash
CORTISOL
(ŠPP OKB 34)
33 krv
Glykovanyacute hemoglobiacuten
(HBA1c) HPLC
Bio-Rad ndash Instruction Manual
(ŠPP OKB 35)
Oddelenie imunodiagnostiky ndash OID Uacutestav laboratoacuternej mediciacuteny SZU a OUacuteSA
Polo
žka
Objekt skuacutešky Zavedenaacute metoacuteda
Ostatneacute
špecifikaacutecie Systeacutem
Biologickyacute
materiaacutel
Analyt
Ukazovateľ
Princiacutep
Druh
Typ
Označenie
1 seacuterum
Protilaacutetky proti tyreoidaacutelnej
peroxidaacuteze
(ATPO)
Chemiluminis-
cenčnaacute
imunoanalyacuteza
ARCHITEKT apllist
anti-TPO
(ŠPP OID1)
Dvojkrokovaacuteimunoanal chemilum
reakcia na mikročasticiach
s polyklonaacutelnou protilaacutetkou
2 seacuterum Karcinoembryonaacutelny antigeacuten
(CEA)
Chemiluminis-
cenčnaacute
imunoanalyacuteza
Beckman Coulter
apl list Access CEA
(ŠPP OID2)
Sendičovaacute imunoenzymatickaacute
imunoanalyacuteza pomocou
monoklonaacutelnych protilaacutetok
3 seacuterum Naacutedorovyacute antigeacuten 125
(CA 125)
Chemiluminis-
cenčnaacute
imunoanalyacuteza
ARCHITEKT apl list
CA 125 II Architect
(ŠPP OID3)
Chemiluminscenčnaacute imunoanalyacuteza
na mikročasticiach pomocou
monoklonaacutelnych protilaacutetok
4 seacuterum Uhľohydraacutet antigeacuten 15-3
(CA 15-3)
Chemiluminis-
cenčnaacute
imunoanalyacuteza
ARCHITEKT apl list
CA 15-3 Architect
(ŠPP OID4)
Chemiluminscenčnaacute imunoanalyacuteza
na mikročasticiach pomocou
monoklonaacutelnych protilaacutetok
3 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Polo
žka
Objekt skuacutešky Zavedenaacute metoacuteda
Ostatneacute
špecifikaacutecie Systeacutem
Biologickyacute
materiaacutel
Analyt
Ukazovateľ
Princiacutep
Druh
Typ
Označenie
5 seacuterum Uhľohydraacutet antigeacuten 19-9
(CA 19-9)
Chemiluminis-
cenčnaacute
imunoanalyacuteza
Beckman Coulter
apl list Acces GI
Monitor
(ŠPP OID5)
Sendvičoveacute imunoenzymatickeacute
stanovenie pomocou
polyklonaacutelnych protilaacutetok
6 seacuterum Voľnyacute tyroxiacuten
(FT4)
Chemiluminis-
cenčnaacute
imunoanalyacuteza
Beckman Coulter
apl list Access freeT4
(ŠPP OID6)
Dvojkrokovaacuteimunoanal chemilum
reakcia na mikročasticiach
s polyklonaacutelnou protilaacutetkou
7 seacuterum Voľnyacute trijoacutedtyroniacuten
(FT3)
Chemiluminis-
cenčnaacute
imunoanalyacuteza
Beckman Coulter
apl list Access freeT3
(ŠPP OID7)
Dvojkrokovaacuteimunoanal chemilum
reakcia na mikročasticiach
s polyklonaacutelnou protilaacutetkou
8 seacuterum Tyreotropiacuten
(TSH)
Chemiluminis-
cenčnaacute
imunoanalyacuteza
Beckman Coulter
HYPERsensitive hTSH
(ŠPP OID8)
Dvojkrokovaacute imnoanal chemilum
reakcia na mikročasticiach
s dvoma monoklonaacutelnymi
protilaacutetkami
9 seacuterum Tyreoglobuliacuten
(TG) TRACE
BRAHMS apllist TG
Kryptor
(ŠPP OID9)
Homogeacutenna sendvičovaacute
munofluoroanalyacuteza TRACE
s dvomi značenyacutemi
monoklonaacutelnymi protilaacutetkami
10 seacuterum Alfafetoproreiacuten
(AFP)
Chemiluminis-
cenčnaacute
imunoanalyacuteza
Beckman Coulter apl
list Access AFP
(ŠPP OID10)
Sendvičoveacute imunoenzymatickeacute
chemiluminiscenčneacute stanovenie
pomocou monoklonaacutelnych
protilaacutetok
11 seacuterum Choriogonadotropiacuten
(HCG)
Chemiluminis -
cenčnaacute
imunoanalyacuteza
Beckman Coulter
apl list Access total
BHCG (5th IS)
(ŠPP OID11)
Sendvičoveacute imunoenzymatickeacute
chemiluminiscenčneacute stanovenie
pomocou monoklonaacutelnych
protilaacutetok
12 seacuterum Cytokeratiacutenovyacute fragment 19
(CYFRA 21-1)
Chemiluminis-
cenčnaacute
imunoanalyacuteza
ARCHITEKT apl list
CYFRA 21-1
(ŠPP OID12)
Dvojkrokovaacute chemiluminiscenčnaacute
imunoanalyacuteza
13 seacuterum
Prostatatickyacute špecifickyacute
antigeacuten ndash celkovyacute
(PSA)
Chemiluminis-
cenčnaacute
imunoanalyacuteza
Beckman Coulter apl
list Acces
Hybritech PSA
(ŠPP OID13)
Sendvičoveacute imunoenzymatickeacute
chemiluminiscenčneacute stanovenie
pomocou monoklonaacutelnych
protilaacutetok
14 seacuterum
Prostatatickyacute špecifickyacute
antigeacuten ndash voľnyacute
(fPSA)
Chemiluminis-
cenčnaacute
imunoanalyacuteza
Beckman Coulter apl
list Acces
Hybritech freePSA
(ŠPP OID14)
Sendvičoveacute imunoenzymatickeacute
chemiluminiscenčneacute stanovenie
pomocou monoklonaacutelnych
protilaacutetok
15 seacuterum Neuroacutenšpecifickaacute enolaacuteza
(NSE) TRACE
BRAHMS apllist NSE
Kryptor
(ŠPP OID15)
Homogeacutenna sendvičovaacute
imunofluoroanalyacuteza TRACE
s dvomi značenyacutemi
monoklonaacutelnymi protilaacutetkami
16 seacuterum
Karcino-antigeacuten
skvamoacuteznych buniek
(SCC)
Chemilumini-
scenčnaacute
imunoanalyacuteza
ARCHITEKT apllist
SCC
(ŠPP OID16)
Dvojkrokovaacute imunoanal chemilum
reakcia na mikročasticiach
s dvoma monoklon protilaacutetkami
4 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Oddelenie hematoloacutegie a transfuzioloacutegie OHT Uacutestav laboratoacuternej mediciacuteny SZU a OUacuteSA
Polo
žka Objekt skuacutešky Zavedenaacute metoacuteda
Ostatneacute
špecifikaacutecie Systeacutem
Biologickyacute
materiaacutel
Analyt
Ukazovateľ
Princiacutep
DruhTyp Označenie
1 celaacute krv
v K3EDTA
Krvnyacute obraz
bez
diferenciaacutel
rozpočtu
leukocytov
+
Diferenciaacutelny
rozpočet
leukocytov z
KO
WBC
Elektrickaacute
impedancia
Prietokovaacute
cytometria
Spektro-
fotometria
Beckman Coulter DxH800
(ŠPP 11HTO)
RBC
HGB
HCT
MCV
MCH
MCHC
PLT
RDW CV
MPV
PDW
Lymfocyty
Ab počet
LYMPH
Monocyty
Ab počet
MONO
Granulocyt
NEU
Ab počet
GrNEU
Granulocyty
EO
Ab počet
GrEO
Granulocyty
BA
Ab počet
GrBA
2 celaacute krv
v K3EDTA
Krvnyacute obraz
bez
diferenciaacutel
rozpočtu
leukocytov
WBC
Elektrickaacute
impedancia
Spektro-
fotometria
Beckman Coulter DxH800
(ŠPP 10HTO)
RBC
HGB
HCT
MCV
MCH
MCHC
PLT
RDW CV
MPV
3 celaacute krv
v K3EDTA
Retikulocyty a
ich parametre
Retikulocyty Elektrickaacute
impedancia
Prietokovaacute
cytometria
Beckman Coulter DxH800
(ŠPP 15HTO)
Retik-ab poč
4 plazma
v citraacutete Na
Aktivovanyacute
parciaacutelny
tromboplastiacuteno
vyacute čas
APTT
KOAG
ACL TOP500 Sysmex CD1500 ndash
Aplikačnyacute list pre Synthasil
(ŠPP 2HTO)
APTT R
5 plazma
v citraacutete Na
Protrombiacutenovyacute
čas
QUICK
KOAG
ACL TOP500 Sysmex CD1500 ndash
Aplikačnyacute list pre RecombiPlastin 2G
(ŠPP 1HTO)
QUICK INR
6 plazma
v citraacutete Na
Trombiacutenovyacute
čas
TT
KOAG
ACL TOP500 Sysmex CD1500 ndash
Aplikačnyacute list pre Thrombin
(ŠPP 3HTO)
TT Ratio
7 plazma
v citraacutete Na Fibrinogeacuten KOAG
ACL TOP500 Sysmex CD1500 ndash
Aplikačnyacute list pre QFA Thrombin
(ŠPP 4HTO)
5 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Polo
žka Objekt skuacutešky Zavedenaacute metoacuteda
Ostatneacute
špecifikaacutecie Systeacutem
Biologickyacute
materiaacutel
Analyt
Ukazovateľ
Princiacutep
DruhTyp Označenie
8 celaacute krv
v K3EDTA Krvnaacute skupina KS+Rh(D) AGLUT
Galileo ECHO ndash ManuaacutelAplikačneacute listy
(ŠPP 22HTO)
9 plazma
v K3EDTA
Skriacutening anti-
Ery protilaacutetok
Skriacutening NAT AGLUT
Galileo ECHO ndash ManuaacutelAplikačneacute listy
(ŠPP 23HTO)
NAT-P1 AGLUT
NAT-P2 AGLUT
NAT-P3 AGLUT
10
plazma
v K3EDTA
a erytrocyty
z transfuacutezneh
o priacutepravku
Kriacutežny pokus AGLUT Galileo ECHO ndash ManuaacutelAplikačneacute listy
(ŠPP 24HTO)
11 celaacute krv
v K3EDTA
Stanovenie CD
znakov
CD3
Prietokovaacute
cytometria
Becton Dickinson FACS Canto - Manuaacutel
(ŠPP 30HTO)
IMF
CD2
CD4
CD5
CD8
CD56
CD7
CD45
CD3CD8
CD3CD4
CD10
CD19
CD20
CD23
Kappa
Lambda
KappaCD19
LambdaCD19
CD38
CD22
CD11c
CD33
CD13
CD34
CD14
HLA DR
CD16
CD15
Oddelenie klinickej imunoloacutegie a alergoloacutegie ndashOKIA Laboratoacuterium s fixnyacutem rozsahom
Polo
žka Objekt skuacutešky Zavedenaacute metoacuteda
Ostatneacute
špecifikaacutecie Systeacutem
Biologickyacute
materiaacutel
Ukazovateľ
Analyt
Parameter
Princiacutep
Druh
Typ
Označenie
1 krv Stanovenie CD
znakov
CD3 (T Lymfocyty)
CD4 (Pomocneacute T Lymfocyty)
CD8 (Cytotoxickeacute T
Lymfocyty)
CD19 (B Lymfocyty)
CD3-CD16+56 (NK bunky)
Prietokovaacute
cytometria
Becton Dickinson FACS
Canto
(ŠPP OKIA11-15)
2 krv
Stanovenie
fagocytovej
aktivity
FAGO Vyšetrenie
fagocytaacuternej aktivity
granulocytov
Prietokovaacute
cytometria
FagoFlowEx Kit Exbio
(ŠPP OKIA21)
3 seacuterum Stanovenie
celkoveacuteho IgE
IGE - Stanovenie celkoveacuteho
IgE
FEIA
(Fluorescenčnaacute
enzyacutemovaacute
imunoanalyacuteza)
ImmunoCAPreg Total IgE
(ŠPP OKIA32)
6 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Polo
žka Objekt skuacutešky Zavedenaacute metoacuteda
Ostatneacute
špecifikaacutecie Systeacutem
Biologickyacute
materiaacutel
Ukazovateľ
Analyt
Parameter
Princiacutep
Druh
Typ
Označenie
4 seacuterum Stanovenie
špecifickyacutech IgE
SIGE - Stanovenie
špecifickyacutech IgE
Enzyacutemovaacute
imunoanalyacuteza
HY-TEC Specific IgE
HYCOR
(ŠPP OKIA41)
SIGE - Stanovenie
špecifickyacutech IgE
FEIA
(Fluorescenčnaacute
enzyacutemovaacute
imunoanalyacuteza)
ImmunoCAPregSpecific
IgE Phadia
(ŠPP OKIA4 2 )
5 seacuterum
Stanovenie parametrov humoraacutelnej odpovede
Enzyacutemovaacute
imunoanalyacuteza
DSX
potravinoveacute
intolerancie
GLIAA Stanovenie protilaacutetok
triedy IgA proti gliadiacutenu
Anti-Gliadin (GAF-3X)
ELISA-(IgA) Euroimmun
(ŠPP OKIA513)
GLIAG Stanovenie protilaacutetok
triedy IgG proti gliadiacutenu
Anti-Gliadin (GAF-3X)
ELISA-(IgG) Euroimmun
(ŠPP OKIA514)
TTG A Stanovenie protilaacutetok
triedy IgA proti tkanivovej
transglutaminaacuteze
Protilaacutetky proti tkaňoveacute
transglutamnaacuteze ELISA
(IgA) Euroimmun
(ŠPP OKIA515)
ASCA Stanovenie protilaacutetok
triedy IgA proti
Saccharomyces cerevisiae
EIA Anti-ASCA IgA
AIDA
(ŠPP anti-ASCA IgA
516)
ASCAG Stanovenie
protilaacutetok triedy IgG proti
Saccharomyces cerevisiae
EIA Anti-ASCA IgG
AIDA
(ŠPP anti-ASCA IgG
517)
autoprotilaacutetky
RFC Stanovenie protilaacutetok
triedy IgA IgM IgM proti
reumatoidneacutemu faktoru
Rf-Check AIDA
(ŠPP OKIA522)
CCP Stanovenie protilaacutetok
proti cyklickeacutemu
citruliacutenoveacutemu proteiacutenu
RACP Detect AIDA
(ŠPP OKIA523)
6 seacuterum
plazma
Stanovenie
zložiek
komplementu
C1F Vyšetrenie funkčnej
aktivity C1 inhibiacutetora
Enzyacutemovaacute
imunoanalyacuteza
A003-MicroVue C1-
Inhibitor Plus EIA Kit
Quidel (ŠPP OKIA61)
Oddelenie klinickej patoloacutegie a cytoloacutegie -OKPC Uacutestav patoloacutegie SZU a OUacuteSA
Polo
žka Objekt skuacutešky Zavedenaacute metoacuteda
Ostatneacute
špecifikaacutecie Systeacutem
Biologickyacute
materiaacutel
Analyt
Ukazovateľ
Princiacutep
Druh
Typ
Označenie
Oddelenie klinickej patoloacutegie a cytoloacutegie -OKPC
1 tkanivo histopatologickeacute
zmeny
Histologickeacute
vyšetrenie tkaniva
(biopsia)
ŠPP OKPC01
ŠPP OKPC02
ŠPP OKPC03
ŠPP OKPC04
(Literatuacutera viď
priacuteloha č 4)
histoloacutegia peroperačneacute biopsie spracovanie
tvrdyacutech tkaniacutev histocheacutemia 1
imunohistocheacutemia 2 mikroskopickeacute hodnotenie
2
moč
vyacutepotok
otlačok
ascitickaacute
tekutina naacuteter
PAB (punkčnaacute
aspiračnaacute
biopsia)
cytopatologickeacute
zmeny
cytologickeacute
vyšetrenie
negynekolo-gickeacute
ŠPP OKPC05
(Literatuacutera viď
priacuteloha č 4)
farbenie naacuteterov polychromatickou metoacutedou
podľa Papanicolaua13
mikroskopickaacute diagnostika
7 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Polo
žka Objekt skuacutešky Zavedenaacute metoacuteda
Ostatneacute
špecifikaacutecie Systeacutem
Biologickyacute
materiaacutel
Analyt
Ukazovateľ
Princiacutep
Druh
Typ
Označenie
3
gynekologickyacute
ster materiaacutel
odobratyacute na
Liquid based
cytology (LBC)
cytopatologickeacute
zmeny
cytologickeacute
vyšetrenie
gynekologickeacute
Liquid based
cytology (LBC)
ŠPP OKPC06
(Literatuacutera viď
priacuteloha č 4)
farbenie naacuteterov polychromatickou metoacutedou
podľa Papanicolaua3 imunocytocheacutemia
mikroskopickaacute diagnostika
systeacutem diagnostickeacuteho hodnotenia gynekologickej
cytoloacutegie Bethesda 2001
1 Priacuteloha 1 Zoznam histochemickyacutech farbiacich a impregnačnyacutech metoacuted na OKPC UacuteP
1 Farbenie hematoxyliacutenom-eoziacutenom
2 Docirckaz polysacharidov PAS reakciou podľa Mc Manusa
3 Farbenie HP podľa Giemsu
4 Impregnaacutecia podľa Gomoriho
5 Farbenie kolageacutenvyacutech vlaacutekien podľa van Giesona
6 Docirckaz železa Perlsovou reakciou
7 Amyloid kongočerveňou podľa Puchtlerovej
8 Impregnačnaacute metoacuteda podľa Grimeliusa
9 Mallory - farbenie na fibriacuten
10 Kysleacute mukopolysacharidy - Alciaacutenovaacute modraacute
11 Farbenie na docirckaz Melaniacutenu podľa Lignaca
12 Mucikarmiacuten podľa Mayera
13 Docirckaz Mycbacterium tuberculosis podľa Ziehl-Neelsena
14 Bakteacuterie podľa Gramma
15 Docirckaz glykogeacutenu metoacutedou PAS-diastaacuteza
16 Zelenyacute Trichroacutem podľa Massona
17 Docirckaz lipidov podľa Lillieho
18 Rezorciacuten-fuchsiacuten podľa Weigerta na elastickeacute vlaacutekna
19 Docirckaz plesniacute ndash impregnačnaacute metoacuteda podľa Gomoriho
20 Kombinovanaacute metoacuteda PAS ndash Alciaacutenovaacute modraacute
2 Priacuteloha 2 Zoznam všetkyacutech antigeacutenov vyšetrovanyacutech imunohistochemickou metoacutedou na OKPC UacuteP
Protilaacutetka proti antigeacutenu Skratka Vyacuterobca
Aktiacuten (smooth muscle) ASM Dako
Alfa-1-fetoproteiacuten AFP Dako
Androgeacutenovyacute receptor AR Novocastra
Bcl-2 BCL2 Dako
Βetacatenin BCAT Dako
Caldesmon CDES Dako
Calretinin CRT Dako
CD10 CD10 Novocastra
CD20cy CD20 L26 Dako
CD30 CD30 Dako
CD31 CD31 Dako
CD34 Class II CD34 Dako
CD45 CD45 LCA Dako
CD45RO CD45RO UCHL1 Dako
CD56 CD56 Dako
CD68 CD68 Novocastra
CD99 CD99 Dako
CD117 CD117 Dako
CDX2 CDX2 Dako
Cytokeratiacuten 56 CK56 Dako
Cytokeratiacuten 7 CK7 Novocastra
Cytokeratiacuten 18 CK18 Dako
Cytokeratiacuten 19 CK19 Dako
Cytokeratiacuten 20 CK20 Novocastra
Cytokeratiacuten AE1AE3 AE13 Dako
Cytokeratiacuten HMW CKHMW Dako
Dezmiacuten DEZ Novocastra
EGFR EGFR Dako
E-kadheriacuten CAD Dako
Epitelovyacute membraacutenovyacute antigeacuten EMA Dako
Estrogeacutenovyacute receptor ER Novocastra
Gastrin GAST Dako
Glukagon GLUK Dako
Gross cystic disease fluid protein-15 GCDF Dako
Ľudskyacute choriogonadotropiacuten HCG Dako
Helicobacter pylori HP Dako
Hepatocyte HEP Dako
HER2 HER2 Dako
Chromograniacuten A CHROM Dako
8 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Inhibiacuten INH Novocastra
Inzuliacuten INZ Dako
Kalcitoniacuten KALC Dako
Kappa light chains IgK Dako
Karbonickaacute anhydraacuteza IX CAIX BioScience
Karcinoembryonaacutelny antigeacuten (monoklonaacutelna) CEA Dako
Ki-67 Ki-67 Novocastra
Lambda light chains IgL Dako
Mammaglobin MAM Dako
Melan A MELAN Dako
Melanozoacutem HMB45 Dako
Mismatch repair protein MLH1 MLH1 Novocastra
Mismatch repair protein MSH2 MSH2 Novocastra
Mismatch repair protein MSH6 MSH6 Dako
Mismatch repair protein PMS2 PMS2 Dako
Myogenin MG Dako
Enolaacuteza špecifickaacute pre neuroacuteny NSE Dako
OCT34 OCT34 Novocastra
Placentaacuterna alkalickaacute fosfataacuteza PLAP Novocastra
p16 p16 Santa Cruz Biotechnology
p53 p53 Novocastra
p63 p63 Dako
-metyl-CoA Racemaacuteza AMACR Dako
Progesteroacutenovyacute receptor PR Novocastra
Prostatickyacute špecifickyacute antigeacuten PSA Dako
Serotonin SRT Dako
Somatostatin SOM Dako
S-100 S-100 Dako
Synaptofyziacuten SYN Novocastra
Tyreoglobuliacuten THG Dako
Tyreoidnyacute transkripčnyacute faktor -1 TTF-1 Dako
Vimentiacuten VIM Dako
WT1 WT1 Dako
3 Priacuteloha 3 Zoznam cytochemickyacutech farbeniacute použiacutevanyacutech na UacuteP
1 Farbenie hematoxyliacutenom-eoziacutenom
2 Farbenie podľa Giemsa ndash Romanowski
3 Farbenie podľa Papanicolaoua ndash polychroacutem EA-50 (PAP)
4 Imunocytochemickeacute vyšetrenie antigeacutenu p16 a Ki67
4 Priacuteloha 4 Zoznam použitej literatuacutery
Literatuacutera použitaacute v ŠPP OKPC01
1 Rosai and Ackerman Surgical Pathology ed Juan Rosai 9 vyd Mosby Elsevier inc 2004
2 Leverrsquos Histopathology of the Skin ed David E Elder 9 vyd Lippincott WilliamsampWilkins 2005
3 Vacek Z Histologie a histologickaacute technika 1 vyd Institut pro dalšiacute vzdělaacutevaacuteniacute pracovniacuteků ve zdravotnictviacute 1996
4 Mezinaacuterodniacute klasifikace nemociacute pro onkologii 3 vyd Světovaacute zdravotnickaacute organizace 2000
5 Pathology and Genetics of Tumours of Haematopoietic and Lymphoid Tissues ed Elaine S Jaffe Nancy Lee Harris Harald Stein James W
Vardiman IARCPress 2001
6 Pathology and Genetics of Tumours of the Breast and Female Genital Organs ed Fattaneh A Tavassoli Peter Devilee IARCPress 2003
7 Pathology and Genetics of Tumours of the Digestive System ed Stanley R Hamilton Lauri A Aaltonen IARCPress 2000
8 Pathology and Genetics of Tumours of Soft Tissue and Bone ed Christopher D M Fletcher K Krishnan Unni Fredrik Mertens IARCPress 2002
9 Pathology and Genetics of Tumours of the Urinary System and Male Genital Organs ed John N Eble Guido Sauter Jonathan I Epstein Isabell A
Sesterhenn IARCPress 2004
10 Pathology and Genetics of Tumours of the Nervous System ed Paul Kleihnes Webster K Cavenee IARCPress 2000
11 Blausteinrsquos Pathology of the Female Genital Tract ed Robert J Kurman Springer-Verlag New York 2002
12 Rosen P P Rosenrsquos Breast Pathology Lippincott WilliamsampWilkins 2001
Literatuacutera použitaacute v ŠPP OKPC02
1 Čunderliacutekovaacute M Balaacutežovaacute V Vybraneacute kapitoly z histologickej techniky Vydavateľstvo Osveta 1990 s167 ISBN 80-217-0269-9
2 Vacek Z Histologie a histologickaacute technika 1 vyd Institut pro dalšiacute vzdělaacutevaacuteniacute pracovniacuteků ve zdravotnictviacute 1996
3 Susan C Lester Manual of Surgical Pathology 2 edition Elsevier Churchill Livingstone 2006
4 Bancroft JD Gamble M Theory and practice of histological techniques Churchil-Livingstone 6th edition 2008 ISBN978-0-443-10279-0 s725
5 Callis GM Bone In Bancroft JD Gamble M Theory and practice of histological techniques Churchil-Livingstone 6th edition 2008 s333 ndash
363
Literatuacutera použitaacute v ŠPP OKPC03
1 Susan C Lester Manual of Surgical Pathology 2 edition Elsevier Churchill Livingstone 2006
2 Rosai and Ackerman Surgical Pathology ed Juan Rosai 9 vyd Mosby Elsevier inc 2004
3 Leverrsquos Histopathology of the Skin ed David E Elder 9 vyd Lippincott WilliamsampWilkins 2005
4 Vacek Z Histologie a histologickaacute technika 1 vyd Institut pro dalšiacute vzdělaacutevaacuteniacute pracovniacuteků ve zdravotnictviacute 1996
5 Mezinaacuterodniacute klasifikace nemociacute pro onkologii 3 vyd Světovaacute zdravotnickaacute organizace 2000
6 Pathology and Genetics of Tumours of Haematopoietic and Lymphoid Tissues ed Elaine S Jaffe Nancy Lee Harris Harald Stein James W
Vardiman IARCPress 2001
9 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
7 Pathology and Genetics of Tumours of the Breast and Female Genital Organs ed Fattaneh ATavassoli Peter Devilee IARCPress 2003
8 Pathology and Genetics of Tumours of the Digestive System ed Stanley R Hamilton Lauri A Aaltonen IARCPress 2000
9 Pathology and Genetics of Tumours of Soft Tissue and Bone ed Christopher D M
10 Fletcher K Krishnan Unni Fredrik Mertens IARCPress 2002
11 Pathology and Genetics of Tumours of the Urinary System and Male Genital Organs ed John N Eble Guido Sauter Jonathan I Epstein Isabell A
Sesterhenn IARCPress 2004
12 Pathology and Genetics of Tumours of the Nervous System ed Paul Kleihnes Webster K Cavenee IARCPress 2000
13 Blausteinrsquos Pathology of the Female Genital Tract ed Robert J Kurman Springer-Verlag
New York 2002
14 Rosen P P Rosenrsquos Breast Pathology Lippincott WilliamsampWilkins 2001
Literatuacutera použitaacute v ŠPP OKPC04
1 Gomolčaacutek P Zaacuteklady imunohistocheacutemie v patoloacutegii IDVPZ Brno 1997 92 s ISBN 80-7013-239-6
2 Key M et al Immunohistochemical staining methods fourth edition education guide DAKO corporatio Carpinteacuteria California 2006 174 s
3 Lukaacuteš Z Draacuteberovaacute E Feit J Vojtěšek B Imunohistochemickeacute metody v biologii a v bioptickeacute diagnostice Acta facultatis medicae Universitatis
Masarykianae Brunensis Sborniacutek praciacute LF v Brně č 112 LF Masarykovy University Brno 1997 147 s ISBN 80-210-0620-X
4 Taylor CR Cote RJ Immunomicroscopy a diagnostic tool for the surgical pathologist third edition Saunders Elsevier 2006 531 s ISBN
0721601820
5 httpwwwihcworldcom
6 httpdistdakocom
7 Shi S-R Key ME Kalra KL Antigen retrieval in formalinfixed paraffin-embedded tissues an enhancement method for immunohistochemical
staining based on microwave oven heating of tissue sections J Histochem Cytochem 1991 39(6) 741-748
8 Shi S-R Cote RJ Taylor CR Antigen retrieval immunohistochemistry past present and future J Histochem Cytochem 1997 45 (3) 327-343
9 Miller RT Technical immunohistochemistry achieving reliability and reproducibility of immunostains [online] New York Society for Applied
Immunohistochemistry Annual Meeting 2001 [cit 2008-12-12] Dostupneacute na lthttpwwwihcworldcom_booksTechnical-IHCpdfgt
Literatuacutera použitaacute v ŠPP OKPC05
1 WiedGKeebler CM Koos LG Patten SFRosenthal DL Compendium on Diagnostic Cytology
2 Richard M De May The Art and Science of Cytopathology
3 Adam P Taborskyacute L Sobek O Kolbich PCytogy of cerebrospinal fluid
4 Takahashi MColor atlas of cancer cytology
Literatuacutera použitaacute v ŠPP OKPC06
1 WiedGKeebler CM Koos LG Patten SFRosenthal DL Compendium on Diagnostic Cytology
2 Richard M De May The Art and Science of Cytopathology
3 JKobilkovaacute JSirackyacute a kolCytodiagnostika v gynekologii
4 JKobilkovaacuteZLojdaJOndrušABekovaacute Gynekologickaacute cytodiagnostika
5 JKobilkovaacute Zaacuteklady cytopatoloacutegie
10 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Flexibilnyacute rozsah akreditaacutecie
Naacutezov akreditovaneacuteho subjektu Onkologickyacute uacutestav sv Alžbety sro
Heydukova 10 812 50 Bratislava
Uacutestav laboratoacuternej mediciacuteny SZU a OUacuteSA
Oddelenie lekaacuterskej genetiky
Flexibilnyacute rozsah akreditaacutecie je zverejnenyacute na adrese
httpwwwousask_imgDocumentsDocumentyZoznam_akreditovanych_cinnostipdf
Polo
žka Objekt skuacutešky Zavedenaacute metoacuteda
Ostatneacute
špecifikaacutecie Systeacutem
Biologickyacute
materiaacutel
Analyt
Ukazovateľ
Princiacutep
Druh
Typ
Označenie
1 Analyacuteza germinatiacutevnych variantov
11
Ľudskaacute
perifeacuterna krv
-Germinatiacutevne varianty v geacutene
BRCA12
Izolaacutecia DNA
PCR
amplifikaacutecia
Sekvenačnaacute
analyacuteza
ŠPP OLG1
(dolu uved orig
praacutece)
Kvalitatiacutevna skuacuteška
12 -Germinatiacutevne varianty v geacutene RET
Izolaacutecia DNA
PCR
amplifikaacutecia
Sekvenačnaacute
analyacuteza
ŠPP OLG2
(dolu uved orig
praacutece)
13 - - Docirckaz germinatiacutevnych variantov v
geacutene MLH1 a MSH2
Izolaacutecia DNA
PCR
amplifikaacutecia
Sekvenačnaacute
analyacuteza
ŠPP OLG10
(dolu uved orig
praacutece)
14 - - Docirckaz germinatiacutevnych variantov
v geacutene VHL
Izolaacutecia DNA
PCR
amplifikaacutecia
Sekvenačnaacute
analyacuteza
SPP OLG14
(dolu uvedeneacute
origpraacutece)
15
- - Docirckaz germinatiacutevnych variantov
v paneli geacutenov asociovanyacutech
s onkologickyacutemi hereditaacuternymi
syndroacutemami
Izolaacutecia DNA
PCR
amplifikaacutecia
Sekvenačnaacute
analyacuteza
SPP OLG15
(dolu uvedeneacute
origpraacutece)
2 Analyacuteza somatickyacutech variantov
21
Fixovaneacute
natiacutevne tkanivo
- Docirckaz somatickyacutech variantov
v exoacutenoch 2 3 a 4 geacutenu KRAS a
NRAS pri naacutedoroch kolorekta
Izolaacutecia DNA
PCR
amplifikaacutecia
Mini-sekvenačnaacute
analyacuteza
Real-Time PCR
ŠPP OLG5
(dolu uved orig
praacutece)
Kvalitatiacutevna skuacuteška 22
- Docirckaz somatickyacutech variantov
v kodoacutene 600 geacutenu BRAF pri
naacutedoroch štiacutetnej žľazy a maliacutegnom
melanoacuteme
Izolaacutecia DNA
PCR
amplifikaacutecia
Mini-sekvenačnaacute
analyacuteza
Real-Time PCR
ŠPP OLG9
(dolu uved orig
praacutece)
ŠPP OLG5
(dolu uved orig
praacutece)
23
Fixovaneacute
natiacutevne
tkanivocytologi
ckeacute stery
- Docirckaz somatickyacutech variantov
v exoacutenoch 18 19 20 a 21 geacutenu
EGFR pri nemalobunkovom
karcinoacuteme pľuacutec
Izolaacutecia DNA
PCR
amplifikaacutecia
Mini-sekvenačnaacute
analyacuteza
Real-Time PCR
ŠPP OLG11
(dolu uved orig
praacutece)
ŠPP OLG5
(dolu uved orig
praacutece)
11 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Polo
žka Objekt skuacutešky Zavedenaacute metoacuteda
Ostatneacute
špecifikaacutecie Systeacutem
Biologickyacute
materiaacutel
Analyt
Ukazovateľ
Princiacutep
Druh
Typ
Označenie
24 Fixovaneacute
natiacutevne tkanivo
-Docirckaz somatickyacutech variantov
v geacutene BRCA12
Izolaacutecia DNA
PCR
amplifikaacutecia
Sekvenačnaacute
analyacuteza
Mini-skevenačnaacute
analyacuteza
ŠPP OLG16
(dolu uved orig
praacutece)
Kvalitatiacutevna skuacuteška
4 Genotypizaacutecia ľudskyacutech papilomaviacuterusov
41
Bunkovaacute
suzpenzia
fixovaneacute
tkanivo
perifeacuterna krv
-Genotypizaacutecia HPV
Izolaacutecia DNA
PCR
amplifikaacutecia
Real-Time PCR
ŠPP OLG3
(dolu uved orig
praacutece)
Kvalitatiacutevna skuacuteška
5 Docirckaz priacutetomnosti HPV
51 Bunkovaacute
suzpenzia -Docirckaz priacutetomnosti HPV
Izolaacutecia DNA
Real-Time PCR
ŠPP OLG13
(dolu uved orig
praacutece)
Kvalitatiacutevna skuacuteška
6 Docirckaz veľkyacutech geacutenovyacutech prestavieb v geacutenoch asociovanyacutech s onkologickyacutemi hereditaacuternymi syndroacutemami metoacutedou MLPA
61
Ľudskaacute
perifeacuterna krv
Fixovaneacute
natiacutevne tkanivo
- - Docirckaz veľkyacutech geacutenovyacutech
prestavieb v geacutenoch asociovanyacutech s
onkologickyacutemi hereditaacuternymi
syndroacutemami metoacutedou MLPA
Izolaacutecia DNA
PCR
amplifikaacutecia
Fragmentačnaacute
analyacuteza
SPP OLG17
(dolu uvedeneacute
origpraacutece)
Kvalitatiacutevna skuacuteška
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG1
1 Friedman L Ostermeyer E A Szabo CI a kol Confirmation of BRCA1 by analysis of germline mutations linked to breast and ovarian cancer in
ten families Nat Genetics 8 399-404 1994
2 Miki Y Katagiri T Kasumi F a kol Mutation analysis in the BRCA2 gene in primary breast cancer Nat Genetics 2 245-7 1996
3 Wagner T M U Hirtenlehner K Shen P a kol Global sequence diversity of BRCA2 analysis of 71 breast cancer families and 95 control
individuals of worldwilde populatins Hum Mol Genetocs Vol 8 No 3 1999
4 QIAamp DNA Mini Kit and OIAamp DNA Blood Mini Kit Handbook
5 Nanodrop ND 1000 useracutes manual
6 Promega Protocols and applications guide The Source for Discovery PCR cheapter Promega Corporation USA 1996
7 Amersham Pharmacia Biotech DNA Silver Staining Kit instructions
8 BigDye Terminator v 11 Cycle Sequencing Kit Protokol Applied Biosystems
9 Applied Biosystems DNA Sequencing Analysis Software Version 51 for Windows XP and 2000 Platforms User Guide Applied Biosystems
10 Applied Biosystems 31303130xl Genetic Analyzers Getting Started Guide Applied Biosystems
11 Konecny M et al Comprehensive genetic characterization of hereditary breastovarian cancer families from Slovakia Breast Cancer Res Treat
(2011) 126119ndash130
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG2
1 Ceccherini I Hofstra RMW Luo Y a kol DNA polymorphisms and conditions for SSCP analysis of the 20 exons of the RET proto-oncogene
Oncogene 9 3025-3029 1994
2 De Groot et al RET as a dignostic and therapeutic target in sporadic and hereditary endocrine tumors 2006 Endocrine Reviews 27(5) 535-560
3 Martucciello G Lerone M et al Multiple endocrine neoplasias type 2B and RET proto-oncogene Ital J Pediatr 2012 Mar 19389 doi
1011861824-7288-38-9 Review
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG3
1 Weismanovaacute E Weismann P Vizvaacuteryovaacute M a kol New approach to human high-risk papillomavirus (HR-HPV) genotyping Neoplasma 49
217-224 2002
2 Amersham Biosciences GenomicPrep Cells and Tissue DNA Isolation Kit instructions
3 Amersham Pharmacia Biotech QuickPrep Total RNA Extraction Kit instructions
4 Amersham Pharmacia Biotech Ready To Go You-Prime First-Strand Beads instructions
5 Amersham Pharmacia Biotech Ready To Go PCR Beads instructions
6 Amersham Pharmacia Biotech DNA Silver Staining Kit instructions
7 F-HPV typingTM Kit Manual
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG5
1 Van Krieken J H J M Jung A Kirchner T a kol KRAS mutation testing for predicting response to anti-EGFR therapy for colorectal carcinoma
proposal for an European quality assurance program Virchows Arch (2008) 453417-431
2 Lievre A Bachet J Le Corre D a kol KRAS mutation status is predictive of response to cetuximab therapy in colorectal cancer Cancer Res
(2006) 668
3 TheraScreen K-RAS Mutation Manual
4 BigDye Terminator v 11 Cycle Sequencing Kit Protokol Applied Biosystems
5 Applied Biosystems DNA Sequencing Analysis Software Version 51 for Windows XP and 2000 Platforms User Guide Applied Biosystems
6 Applied Biosystems 3500 Genetic Analyzers Getting Started Guide Applied Biosystems
8 SNaPshot Multiplex Kit ndash protocol and manual
12 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG9 1 Nikiforov YE thyroid carcinoma molecular pathways and therapeutic targets Modern pathology 21S37-S43 2008
2 Elisei R Ugolini C Viola D Lupi C et al BRAF V600E mutation and outcome of patients with papillary thyroid carcinoma
A 15-year median follow-up study J Clin endocrine Metab 93(10)3943-3949 2008
3 SNaPshot Multiplex Kit ndash protocol and manual Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG10
1 Brigitte Wolf Silvia Henglmueller at al Spectrum of germ-line MLH1 and MSH2 mutations in Austrian patientswith hereditary nonpolyposis
colorectal cancer The Middle European Journal of Medicine 2005 1177ndash8 269ndash277
2 Elisabeth mangold Constanze Pagenstecher et al Spectrum and frequencies of mutations in MSH2 and MLH1 identified in 1721 german families
suspected of hereditary nonpolyposis colorectal cancer Int J Cancer 2005 116 692-702
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG11
1 Rosell R Moran T Queralt C Porta R Cardenal F Camps C Majem M Lopez-Vivanco G Isla D Provencio M Insa A Massuti
B Gonzalez-Larriba J L Paz-Ares L Bover I Garcia-Campelo R Moreno M A Catot S Rolfo C Reguart N Palmero R Sanchez
JM Bastus R Mayo C Bertran- Alamillo J Molina M A Sanchez J J Taron M (2009) Screening for epidermal growth factor receptor
mutations in lung cancer N Engl J Med 361 958-967
2 Peacuterez-Soler R Chachoua A Hammond L A Rowinsky E K Huberman M Karp M Rigas J Clark G M Santabaacuterbara P Bonomi P
(2004) Determinants of Tumor Response and Survival With Erlotinib in Patients With NonndashSmall-Cell Lung Cancer Journal og Clinical
Oncology 22 16
3 Pines G Koumlstler W JYosef Yarden Department of Biological Regulation The Weizmann Institute of Science Rehovot 76100 Israel (2010)
Oncogenic mutant forms of EGFR lessons in signal transduction and targets for cancer therapy FEBSLett 584 (12) 2699ndash2706
4 ABI PRISM SnaPshot Multiplex Kit ndashProtocol and manual
5 cobasreg EGFR Mutation Test ndash User Manual
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG13
1 cobasreg 4800 HPV Test ndash Dokument č 05990343001-04SK Roche Diagnostics GmbH
2cobasreg 4800 HPV Test ndash Dokument č 05641268001-01 Roche Molecular Systems Inc
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG14
1 Nielsen SM Rhodes L Blanco I a kol 2016 Von Hippel-Lindau Disease Genetics and Role of Genetic Counseling in a Multiple Neoplasia
Syndrome J Clin Oncol 34(18)2172-2181
2 Alberta Health Services 2011 Renal cell carcinoma and genetic testing Clinical Practice Guideline GU-005
3 Chittiboina P Lonser RR 2015 Von Hippel-Lindau disease Handb Clin Neurol132139-156
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG15
1 Hereditary Cancer Solution by Sophia Genetics ndash Users guide using DNA library prep kit by Sophia genetics 48 samples
2 BRCA Hereditary Cancer MASTR Plus kit with drMID for Ilumina NGS systems ndash instructions for use
3 Crawford B Adams S B Sittler et al (2017) Multi-gene panel testing for hereditary cancer predisposition in unsolved high-risk breast and ovarian
cancer patients Breast cancer research and treatment 163(2) 383-390
4 Grissom A A Friend P J (2016) Multigene Panel Testing for Hereditary Cancer Risk Journal of the advanced practitioner in oncology 7(4) 394-
407
5 Lorans M Dow E Macrae FA Winship IM Buchanan DD (2018) Update on Hereditary Colorectal Cancer Improving the Clinical Utility of
Multigene Panel Testing Clin Colorectal Cancer 17(2)e293-e305
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG16
1 Ledermann PARP inhibitors in ovarian cancer Annals of Oncology (2016) 27 i40ndashi44
2 Koczkowska M et al Detection of somatic BRCA12 mutations in ovarian cancer - next-generation sequencing analysis of 100 cases Cancer Med
2016 Jul5(7)1640-6
3 Dougherty BA et al Biological and clinical evidence for somatic mutations in BRCA1 and BRCA2 as predictive markers for olaparib response in
high-grade serous ovarian cancers in the maintenance setting Oncotarget 2017 Jul 48(27)43653-43661
4 Maxwell KN et al BRCA locus-specific loss of heterozygosity in germline BRCA1 and BRCA2 carriers Nat Commun 2017 Aug 228(1)319
5 httpswwwagilentcomcslibrarybrochuresBrochure20Complete20solution20BRCA20MASTR20(Plus)20Dx20v1708pdf
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG17
1 MRC-Holland ndash MLPA General Protocol httpswwwmlpacom
2 Ticha I Kleibl Z Stribrna J a kol Screening for genomic rearragements in a genes in Czech high-risk breastovarian cancer patients high
proportion of population specific alterations in gene Breast Cancer Research and Treatment 2010 124 (2)337-347
3 Sluiter MD van Rensburg EJ Large genomic rearragements of the BRCA1 and BRCA2 genes review of the literature and report of a novel BRCA1
mutation Breast Cancer Research and Treatment 2011 125 325-349
Osoby spocircsobileacute modifikovať a validovať metoacutedy na Oddeleniacute lekaacuterskej genetiky
Meno a priezvisko tituly Spocircsobilosť modifikovať a validovať metoacutedy
ndash čiacuteslo položky v rozsahu akreditaacutecie
Regiacutena Lohajovaacute Behulovaacute RNDr PhD 11 až 61
Katariacutena Zaacutevodnaacute RNDr PhD 11 až 61
Ľudmila Vavrovaacute Ing PhD 11 až 61
Tomaacuteš Slamka Mgr 11 až 61
Lukaacuteš Šebest Mgr PhD 11 až 61
Aster Alemayehu RNDr PhD 11 až 61
13 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Použiteacute skratky
AGLUT ndash aglutinačnaacute reakcia
AOD ndash askorbaacutetoxidaacuteza
BRCA ndash označenie geacutenu asociovaneacuteho s dedičnou formou mamaacuternehoovariaacutelneho karcinoacutemu
CDKN2A ndash označenie geacutenu asociovaneacuteho s dedičnou formou maliacutegneho melanoacutemu
E6E7 - HPV viacuterusoveacute onkogeacuteny asociovaneacute so vznikom a progresiou Ca krčka maternice
FOTO - fotometria
GLD ndash glutamaacutetdehydrogenaacuteza
GPO ndash glycerol-3-fosfaacutet-oxidaacuteza
HPLC ndash High Performance Liquid Chromatography
HPV ndash human papillomavirus (ľudskyacute papilloma viacuterus)
CHOD ndash cholesteroloxidaacuteza
IFCC ndash International Federation for Clinical Chemistry
IMF ndash meranie fluorescencie po značeniacute buniek protilaacutetkami
KOAG ndash Coagulation Point Detection Method
KRAS ndash označenie geacutenu kt somatickeacute mutaacutecie v suacute predikatiacutevnym markerom pri metastazujuacutecom ca hrubeacuteho čreva
LATEX ndash Latex immunoassay method
MLH1 - označenie geacutenu asociovaneacuteho s dedičnou formou kolorektaacutelneho karcinoacutemu
MSH2 - označenie geacutenu asociovaneacuteho s dedičnou formou kolorektaacutelneho karcinoacutemu
NRAS ndash označenie geacutenu kt somatickeacute mutaacutecie v suacute predikatiacutevnym markerom pri metastazujuacutecom ca hrubeacuteho čreva
OHT - Oddelenie hematoloacutegie a transfuzioloacutegie
OID ndash Oddelenie imunodiagnostiky
OKB ndash Oddelenie klinickej biocheacutemie
OKIA - Oddelenie klinickej imunoloacutegie a alergoloacutegie
OKPC - Oddelenie klinickej patoloacutegie a cytoloacutegie
OLG ndash Oddelenie lekaacuterskej genetiky
PAP ndash peroxidaacuteza
PCR ndash polymeraacutezovaacute reťazovaacute reakcia
PHOTO ndash spektrofotometrickaacute metoacuteda
PLP ndash pyridoxalfosfaacutet
POD ndash peroxidaacuteza
RET ndash označenie geacutenu v dedičnej forme medulaacuterneho karcinoacutemu a syndroacutemu mnohopočetnej endokrinnej neoplaacutezie typu 2
RIA - Radio Immunoassay
RT - Real-Time
ŠPP ndash Štandardnyacute pracovnyacute postup
TPO ndash Tyreoidaacutelna peroxidaacuteza
TRACE ndash Time Resolved Amplified Cryptate Emission
2 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Polo
žka
Objekt skuacutešky Zavedenaacute metoacuteda
Ostatneacute
špecifikaacutecie Systeacutem
Biologickyacute
materiaacutel
Analyt
Ukazovateľ
Princiacutep
Druh
Typ
Označenie
18 seacuterum
Fosfor (P) Spektrofotometria
Beckman Coulter ndash Inorg
Phosphor
(ŠPP OKB 18)
UV-molybdaacutetovaacute metoacuteda
19
seacuterum
Horčiacutek (MG) Spektrofotometria
Beckman Coulter ndash
Magnesium
(SPP OKB 19)
Xylidylovaacute modraacute
20
seacuterum
Železo (FE) Spektrofotometria
Beckman Coulter ndash Iron
(ŠPP OKB 20) Metoacuteda s TPTZ
21
seacuterum
Laktaacutetdehydrogenaacuteza
(LDH) Spektrofotometria
Beckman Coulter ndash LD
(ŠPP OKB 21) IFCC metoacuteda (37degC LrarrP)
22 seacuterum
Kreatiacutenkinaacuteza (CK) Spektrofotometria
Beckman Coulter ndash CK (NAC)
(ŠPP OKB 22) IFCC metoacuteda (NAC 37degC)
23 seacuterum
Amylaacuteza (AMS) Spektrofotometria
Beckman Coulter ndash α-Amylase
(ŠPP OKB 23)
IFCC metoacuteda ( ethyliden-
G7PNP)
24 seacuterum
Imunoglobuliacuten G (IGG) Imunoturbidimetria
Beckman Coulter ndash IgG
(ŠPP OKB 24)
25 seacuterum
Imunoglobuliacuten A (IGA) Imunoturbidimetria
Beckman Coulter ndash IgA
(ŠPP OKB 25)
26 seacuterum
Imunoglobuliacuten M (IGM) Imunoturbidimetria
Beckman Coulter ndash IgM
(ŠPP OKB 26)
27 seacuterum
C-reaktiacutevny proteiacuten
(CRP) Imunoturbidimetria
Beckman Coulter ndash CRP Latex
(ŠPP OKB 27) Latex
28 seacuterum
Komplement C3 (C3) Imunoturbidimetria
Beckman Coulter ndash C3
(ŠPP OKB 30)
29 seacuterum
Komplement C4 (C4) Imunoturbidimetria
Beckman Coulter ndash C4
(ŠPP OKB 31)
30 seacuterum
Folaacutet (FOL)
Chemilumini-
scenčnaacute
imunoanalyacuteza
Beckman Coulter ndash FOLATE
(ŠPP OKB 32)
31 seacuterum
Vitamiacuten B12 (VITB12)
Chemilumini-
scenčnaacute
imunoanalyacuteza
Beckman Coulter ndash VITAMIN
B12
(ŠPP OKB 33)
32 seacuterum
Cortizol (CORT)
Chemilumini-
scenčnaacute
imunoanalyacuteza
Beckman Coulter ndash
CORTISOL
(ŠPP OKB 34)
33 krv
Glykovanyacute hemoglobiacuten
(HBA1c) HPLC
Bio-Rad ndash Instruction Manual
(ŠPP OKB 35)
Oddelenie imunodiagnostiky ndash OID Uacutestav laboratoacuternej mediciacuteny SZU a OUacuteSA
Polo
žka
Objekt skuacutešky Zavedenaacute metoacuteda
Ostatneacute
špecifikaacutecie Systeacutem
Biologickyacute
materiaacutel
Analyt
Ukazovateľ
Princiacutep
Druh
Typ
Označenie
1 seacuterum
Protilaacutetky proti tyreoidaacutelnej
peroxidaacuteze
(ATPO)
Chemiluminis-
cenčnaacute
imunoanalyacuteza
ARCHITEKT apllist
anti-TPO
(ŠPP OID1)
Dvojkrokovaacuteimunoanal chemilum
reakcia na mikročasticiach
s polyklonaacutelnou protilaacutetkou
2 seacuterum Karcinoembryonaacutelny antigeacuten
(CEA)
Chemiluminis-
cenčnaacute
imunoanalyacuteza
Beckman Coulter
apl list Access CEA
(ŠPP OID2)
Sendičovaacute imunoenzymatickaacute
imunoanalyacuteza pomocou
monoklonaacutelnych protilaacutetok
3 seacuterum Naacutedorovyacute antigeacuten 125
(CA 125)
Chemiluminis-
cenčnaacute
imunoanalyacuteza
ARCHITEKT apl list
CA 125 II Architect
(ŠPP OID3)
Chemiluminscenčnaacute imunoanalyacuteza
na mikročasticiach pomocou
monoklonaacutelnych protilaacutetok
4 seacuterum Uhľohydraacutet antigeacuten 15-3
(CA 15-3)
Chemiluminis-
cenčnaacute
imunoanalyacuteza
ARCHITEKT apl list
CA 15-3 Architect
(ŠPP OID4)
Chemiluminscenčnaacute imunoanalyacuteza
na mikročasticiach pomocou
monoklonaacutelnych protilaacutetok
3 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Polo
žka
Objekt skuacutešky Zavedenaacute metoacuteda
Ostatneacute
špecifikaacutecie Systeacutem
Biologickyacute
materiaacutel
Analyt
Ukazovateľ
Princiacutep
Druh
Typ
Označenie
5 seacuterum Uhľohydraacutet antigeacuten 19-9
(CA 19-9)
Chemiluminis-
cenčnaacute
imunoanalyacuteza
Beckman Coulter
apl list Acces GI
Monitor
(ŠPP OID5)
Sendvičoveacute imunoenzymatickeacute
stanovenie pomocou
polyklonaacutelnych protilaacutetok
6 seacuterum Voľnyacute tyroxiacuten
(FT4)
Chemiluminis-
cenčnaacute
imunoanalyacuteza
Beckman Coulter
apl list Access freeT4
(ŠPP OID6)
Dvojkrokovaacuteimunoanal chemilum
reakcia na mikročasticiach
s polyklonaacutelnou protilaacutetkou
7 seacuterum Voľnyacute trijoacutedtyroniacuten
(FT3)
Chemiluminis-
cenčnaacute
imunoanalyacuteza
Beckman Coulter
apl list Access freeT3
(ŠPP OID7)
Dvojkrokovaacuteimunoanal chemilum
reakcia na mikročasticiach
s polyklonaacutelnou protilaacutetkou
8 seacuterum Tyreotropiacuten
(TSH)
Chemiluminis-
cenčnaacute
imunoanalyacuteza
Beckman Coulter
HYPERsensitive hTSH
(ŠPP OID8)
Dvojkrokovaacute imnoanal chemilum
reakcia na mikročasticiach
s dvoma monoklonaacutelnymi
protilaacutetkami
9 seacuterum Tyreoglobuliacuten
(TG) TRACE
BRAHMS apllist TG
Kryptor
(ŠPP OID9)
Homogeacutenna sendvičovaacute
munofluoroanalyacuteza TRACE
s dvomi značenyacutemi
monoklonaacutelnymi protilaacutetkami
10 seacuterum Alfafetoproreiacuten
(AFP)
Chemiluminis-
cenčnaacute
imunoanalyacuteza
Beckman Coulter apl
list Access AFP
(ŠPP OID10)
Sendvičoveacute imunoenzymatickeacute
chemiluminiscenčneacute stanovenie
pomocou monoklonaacutelnych
protilaacutetok
11 seacuterum Choriogonadotropiacuten
(HCG)
Chemiluminis -
cenčnaacute
imunoanalyacuteza
Beckman Coulter
apl list Access total
BHCG (5th IS)
(ŠPP OID11)
Sendvičoveacute imunoenzymatickeacute
chemiluminiscenčneacute stanovenie
pomocou monoklonaacutelnych
protilaacutetok
12 seacuterum Cytokeratiacutenovyacute fragment 19
(CYFRA 21-1)
Chemiluminis-
cenčnaacute
imunoanalyacuteza
ARCHITEKT apl list
CYFRA 21-1
(ŠPP OID12)
Dvojkrokovaacute chemiluminiscenčnaacute
imunoanalyacuteza
13 seacuterum
Prostatatickyacute špecifickyacute
antigeacuten ndash celkovyacute
(PSA)
Chemiluminis-
cenčnaacute
imunoanalyacuteza
Beckman Coulter apl
list Acces
Hybritech PSA
(ŠPP OID13)
Sendvičoveacute imunoenzymatickeacute
chemiluminiscenčneacute stanovenie
pomocou monoklonaacutelnych
protilaacutetok
14 seacuterum
Prostatatickyacute špecifickyacute
antigeacuten ndash voľnyacute
(fPSA)
Chemiluminis-
cenčnaacute
imunoanalyacuteza
Beckman Coulter apl
list Acces
Hybritech freePSA
(ŠPP OID14)
Sendvičoveacute imunoenzymatickeacute
chemiluminiscenčneacute stanovenie
pomocou monoklonaacutelnych
protilaacutetok
15 seacuterum Neuroacutenšpecifickaacute enolaacuteza
(NSE) TRACE
BRAHMS apllist NSE
Kryptor
(ŠPP OID15)
Homogeacutenna sendvičovaacute
imunofluoroanalyacuteza TRACE
s dvomi značenyacutemi
monoklonaacutelnymi protilaacutetkami
16 seacuterum
Karcino-antigeacuten
skvamoacuteznych buniek
(SCC)
Chemilumini-
scenčnaacute
imunoanalyacuteza
ARCHITEKT apllist
SCC
(ŠPP OID16)
Dvojkrokovaacute imunoanal chemilum
reakcia na mikročasticiach
s dvoma monoklon protilaacutetkami
4 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Oddelenie hematoloacutegie a transfuzioloacutegie OHT Uacutestav laboratoacuternej mediciacuteny SZU a OUacuteSA
Polo
žka Objekt skuacutešky Zavedenaacute metoacuteda
Ostatneacute
špecifikaacutecie Systeacutem
Biologickyacute
materiaacutel
Analyt
Ukazovateľ
Princiacutep
DruhTyp Označenie
1 celaacute krv
v K3EDTA
Krvnyacute obraz
bez
diferenciaacutel
rozpočtu
leukocytov
+
Diferenciaacutelny
rozpočet
leukocytov z
KO
WBC
Elektrickaacute
impedancia
Prietokovaacute
cytometria
Spektro-
fotometria
Beckman Coulter DxH800
(ŠPP 11HTO)
RBC
HGB
HCT
MCV
MCH
MCHC
PLT
RDW CV
MPV
PDW
Lymfocyty
Ab počet
LYMPH
Monocyty
Ab počet
MONO
Granulocyt
NEU
Ab počet
GrNEU
Granulocyty
EO
Ab počet
GrEO
Granulocyty
BA
Ab počet
GrBA
2 celaacute krv
v K3EDTA
Krvnyacute obraz
bez
diferenciaacutel
rozpočtu
leukocytov
WBC
Elektrickaacute
impedancia
Spektro-
fotometria
Beckman Coulter DxH800
(ŠPP 10HTO)
RBC
HGB
HCT
MCV
MCH
MCHC
PLT
RDW CV
MPV
3 celaacute krv
v K3EDTA
Retikulocyty a
ich parametre
Retikulocyty Elektrickaacute
impedancia
Prietokovaacute
cytometria
Beckman Coulter DxH800
(ŠPP 15HTO)
Retik-ab poč
4 plazma
v citraacutete Na
Aktivovanyacute
parciaacutelny
tromboplastiacuteno
vyacute čas
APTT
KOAG
ACL TOP500 Sysmex CD1500 ndash
Aplikačnyacute list pre Synthasil
(ŠPP 2HTO)
APTT R
5 plazma
v citraacutete Na
Protrombiacutenovyacute
čas
QUICK
KOAG
ACL TOP500 Sysmex CD1500 ndash
Aplikačnyacute list pre RecombiPlastin 2G
(ŠPP 1HTO)
QUICK INR
6 plazma
v citraacutete Na
Trombiacutenovyacute
čas
TT
KOAG
ACL TOP500 Sysmex CD1500 ndash
Aplikačnyacute list pre Thrombin
(ŠPP 3HTO)
TT Ratio
7 plazma
v citraacutete Na Fibrinogeacuten KOAG
ACL TOP500 Sysmex CD1500 ndash
Aplikačnyacute list pre QFA Thrombin
(ŠPP 4HTO)
5 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Polo
žka Objekt skuacutešky Zavedenaacute metoacuteda
Ostatneacute
špecifikaacutecie Systeacutem
Biologickyacute
materiaacutel
Analyt
Ukazovateľ
Princiacutep
DruhTyp Označenie
8 celaacute krv
v K3EDTA Krvnaacute skupina KS+Rh(D) AGLUT
Galileo ECHO ndash ManuaacutelAplikačneacute listy
(ŠPP 22HTO)
9 plazma
v K3EDTA
Skriacutening anti-
Ery protilaacutetok
Skriacutening NAT AGLUT
Galileo ECHO ndash ManuaacutelAplikačneacute listy
(ŠPP 23HTO)
NAT-P1 AGLUT
NAT-P2 AGLUT
NAT-P3 AGLUT
10
plazma
v K3EDTA
a erytrocyty
z transfuacutezneh
o priacutepravku
Kriacutežny pokus AGLUT Galileo ECHO ndash ManuaacutelAplikačneacute listy
(ŠPP 24HTO)
11 celaacute krv
v K3EDTA
Stanovenie CD
znakov
CD3
Prietokovaacute
cytometria
Becton Dickinson FACS Canto - Manuaacutel
(ŠPP 30HTO)
IMF
CD2
CD4
CD5
CD8
CD56
CD7
CD45
CD3CD8
CD3CD4
CD10
CD19
CD20
CD23
Kappa
Lambda
KappaCD19
LambdaCD19
CD38
CD22
CD11c
CD33
CD13
CD34
CD14
HLA DR
CD16
CD15
Oddelenie klinickej imunoloacutegie a alergoloacutegie ndashOKIA Laboratoacuterium s fixnyacutem rozsahom
Polo
žka Objekt skuacutešky Zavedenaacute metoacuteda
Ostatneacute
špecifikaacutecie Systeacutem
Biologickyacute
materiaacutel
Ukazovateľ
Analyt
Parameter
Princiacutep
Druh
Typ
Označenie
1 krv Stanovenie CD
znakov
CD3 (T Lymfocyty)
CD4 (Pomocneacute T Lymfocyty)
CD8 (Cytotoxickeacute T
Lymfocyty)
CD19 (B Lymfocyty)
CD3-CD16+56 (NK bunky)
Prietokovaacute
cytometria
Becton Dickinson FACS
Canto
(ŠPP OKIA11-15)
2 krv
Stanovenie
fagocytovej
aktivity
FAGO Vyšetrenie
fagocytaacuternej aktivity
granulocytov
Prietokovaacute
cytometria
FagoFlowEx Kit Exbio
(ŠPP OKIA21)
3 seacuterum Stanovenie
celkoveacuteho IgE
IGE - Stanovenie celkoveacuteho
IgE
FEIA
(Fluorescenčnaacute
enzyacutemovaacute
imunoanalyacuteza)
ImmunoCAPreg Total IgE
(ŠPP OKIA32)
6 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Polo
žka Objekt skuacutešky Zavedenaacute metoacuteda
Ostatneacute
špecifikaacutecie Systeacutem
Biologickyacute
materiaacutel
Ukazovateľ
Analyt
Parameter
Princiacutep
Druh
Typ
Označenie
4 seacuterum Stanovenie
špecifickyacutech IgE
SIGE - Stanovenie
špecifickyacutech IgE
Enzyacutemovaacute
imunoanalyacuteza
HY-TEC Specific IgE
HYCOR
(ŠPP OKIA41)
SIGE - Stanovenie
špecifickyacutech IgE
FEIA
(Fluorescenčnaacute
enzyacutemovaacute
imunoanalyacuteza)
ImmunoCAPregSpecific
IgE Phadia
(ŠPP OKIA4 2 )
5 seacuterum
Stanovenie parametrov humoraacutelnej odpovede
Enzyacutemovaacute
imunoanalyacuteza
DSX
potravinoveacute
intolerancie
GLIAA Stanovenie protilaacutetok
triedy IgA proti gliadiacutenu
Anti-Gliadin (GAF-3X)
ELISA-(IgA) Euroimmun
(ŠPP OKIA513)
GLIAG Stanovenie protilaacutetok
triedy IgG proti gliadiacutenu
Anti-Gliadin (GAF-3X)
ELISA-(IgG) Euroimmun
(ŠPP OKIA514)
TTG A Stanovenie protilaacutetok
triedy IgA proti tkanivovej
transglutaminaacuteze
Protilaacutetky proti tkaňoveacute
transglutamnaacuteze ELISA
(IgA) Euroimmun
(ŠPP OKIA515)
ASCA Stanovenie protilaacutetok
triedy IgA proti
Saccharomyces cerevisiae
EIA Anti-ASCA IgA
AIDA
(ŠPP anti-ASCA IgA
516)
ASCAG Stanovenie
protilaacutetok triedy IgG proti
Saccharomyces cerevisiae
EIA Anti-ASCA IgG
AIDA
(ŠPP anti-ASCA IgG
517)
autoprotilaacutetky
RFC Stanovenie protilaacutetok
triedy IgA IgM IgM proti
reumatoidneacutemu faktoru
Rf-Check AIDA
(ŠPP OKIA522)
CCP Stanovenie protilaacutetok
proti cyklickeacutemu
citruliacutenoveacutemu proteiacutenu
RACP Detect AIDA
(ŠPP OKIA523)
6 seacuterum
plazma
Stanovenie
zložiek
komplementu
C1F Vyšetrenie funkčnej
aktivity C1 inhibiacutetora
Enzyacutemovaacute
imunoanalyacuteza
A003-MicroVue C1-
Inhibitor Plus EIA Kit
Quidel (ŠPP OKIA61)
Oddelenie klinickej patoloacutegie a cytoloacutegie -OKPC Uacutestav patoloacutegie SZU a OUacuteSA
Polo
žka Objekt skuacutešky Zavedenaacute metoacuteda
Ostatneacute
špecifikaacutecie Systeacutem
Biologickyacute
materiaacutel
Analyt
Ukazovateľ
Princiacutep
Druh
Typ
Označenie
Oddelenie klinickej patoloacutegie a cytoloacutegie -OKPC
1 tkanivo histopatologickeacute
zmeny
Histologickeacute
vyšetrenie tkaniva
(biopsia)
ŠPP OKPC01
ŠPP OKPC02
ŠPP OKPC03
ŠPP OKPC04
(Literatuacutera viď
priacuteloha č 4)
histoloacutegia peroperačneacute biopsie spracovanie
tvrdyacutech tkaniacutev histocheacutemia 1
imunohistocheacutemia 2 mikroskopickeacute hodnotenie
2
moč
vyacutepotok
otlačok
ascitickaacute
tekutina naacuteter
PAB (punkčnaacute
aspiračnaacute
biopsia)
cytopatologickeacute
zmeny
cytologickeacute
vyšetrenie
negynekolo-gickeacute
ŠPP OKPC05
(Literatuacutera viď
priacuteloha č 4)
farbenie naacuteterov polychromatickou metoacutedou
podľa Papanicolaua13
mikroskopickaacute diagnostika
7 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Polo
žka Objekt skuacutešky Zavedenaacute metoacuteda
Ostatneacute
špecifikaacutecie Systeacutem
Biologickyacute
materiaacutel
Analyt
Ukazovateľ
Princiacutep
Druh
Typ
Označenie
3
gynekologickyacute
ster materiaacutel
odobratyacute na
Liquid based
cytology (LBC)
cytopatologickeacute
zmeny
cytologickeacute
vyšetrenie
gynekologickeacute
Liquid based
cytology (LBC)
ŠPP OKPC06
(Literatuacutera viď
priacuteloha č 4)
farbenie naacuteterov polychromatickou metoacutedou
podľa Papanicolaua3 imunocytocheacutemia
mikroskopickaacute diagnostika
systeacutem diagnostickeacuteho hodnotenia gynekologickej
cytoloacutegie Bethesda 2001
1 Priacuteloha 1 Zoznam histochemickyacutech farbiacich a impregnačnyacutech metoacuted na OKPC UacuteP
1 Farbenie hematoxyliacutenom-eoziacutenom
2 Docirckaz polysacharidov PAS reakciou podľa Mc Manusa
3 Farbenie HP podľa Giemsu
4 Impregnaacutecia podľa Gomoriho
5 Farbenie kolageacutenvyacutech vlaacutekien podľa van Giesona
6 Docirckaz železa Perlsovou reakciou
7 Amyloid kongočerveňou podľa Puchtlerovej
8 Impregnačnaacute metoacuteda podľa Grimeliusa
9 Mallory - farbenie na fibriacuten
10 Kysleacute mukopolysacharidy - Alciaacutenovaacute modraacute
11 Farbenie na docirckaz Melaniacutenu podľa Lignaca
12 Mucikarmiacuten podľa Mayera
13 Docirckaz Mycbacterium tuberculosis podľa Ziehl-Neelsena
14 Bakteacuterie podľa Gramma
15 Docirckaz glykogeacutenu metoacutedou PAS-diastaacuteza
16 Zelenyacute Trichroacutem podľa Massona
17 Docirckaz lipidov podľa Lillieho
18 Rezorciacuten-fuchsiacuten podľa Weigerta na elastickeacute vlaacutekna
19 Docirckaz plesniacute ndash impregnačnaacute metoacuteda podľa Gomoriho
20 Kombinovanaacute metoacuteda PAS ndash Alciaacutenovaacute modraacute
2 Priacuteloha 2 Zoznam všetkyacutech antigeacutenov vyšetrovanyacutech imunohistochemickou metoacutedou na OKPC UacuteP
Protilaacutetka proti antigeacutenu Skratka Vyacuterobca
Aktiacuten (smooth muscle) ASM Dako
Alfa-1-fetoproteiacuten AFP Dako
Androgeacutenovyacute receptor AR Novocastra
Bcl-2 BCL2 Dako
Βetacatenin BCAT Dako
Caldesmon CDES Dako
Calretinin CRT Dako
CD10 CD10 Novocastra
CD20cy CD20 L26 Dako
CD30 CD30 Dako
CD31 CD31 Dako
CD34 Class II CD34 Dako
CD45 CD45 LCA Dako
CD45RO CD45RO UCHL1 Dako
CD56 CD56 Dako
CD68 CD68 Novocastra
CD99 CD99 Dako
CD117 CD117 Dako
CDX2 CDX2 Dako
Cytokeratiacuten 56 CK56 Dako
Cytokeratiacuten 7 CK7 Novocastra
Cytokeratiacuten 18 CK18 Dako
Cytokeratiacuten 19 CK19 Dako
Cytokeratiacuten 20 CK20 Novocastra
Cytokeratiacuten AE1AE3 AE13 Dako
Cytokeratiacuten HMW CKHMW Dako
Dezmiacuten DEZ Novocastra
EGFR EGFR Dako
E-kadheriacuten CAD Dako
Epitelovyacute membraacutenovyacute antigeacuten EMA Dako
Estrogeacutenovyacute receptor ER Novocastra
Gastrin GAST Dako
Glukagon GLUK Dako
Gross cystic disease fluid protein-15 GCDF Dako
Ľudskyacute choriogonadotropiacuten HCG Dako
Helicobacter pylori HP Dako
Hepatocyte HEP Dako
HER2 HER2 Dako
Chromograniacuten A CHROM Dako
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Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Inhibiacuten INH Novocastra
Inzuliacuten INZ Dako
Kalcitoniacuten KALC Dako
Kappa light chains IgK Dako
Karbonickaacute anhydraacuteza IX CAIX BioScience
Karcinoembryonaacutelny antigeacuten (monoklonaacutelna) CEA Dako
Ki-67 Ki-67 Novocastra
Lambda light chains IgL Dako
Mammaglobin MAM Dako
Melan A MELAN Dako
Melanozoacutem HMB45 Dako
Mismatch repair protein MLH1 MLH1 Novocastra
Mismatch repair protein MSH2 MSH2 Novocastra
Mismatch repair protein MSH6 MSH6 Dako
Mismatch repair protein PMS2 PMS2 Dako
Myogenin MG Dako
Enolaacuteza špecifickaacute pre neuroacuteny NSE Dako
OCT34 OCT34 Novocastra
Placentaacuterna alkalickaacute fosfataacuteza PLAP Novocastra
p16 p16 Santa Cruz Biotechnology
p53 p53 Novocastra
p63 p63 Dako
-metyl-CoA Racemaacuteza AMACR Dako
Progesteroacutenovyacute receptor PR Novocastra
Prostatickyacute špecifickyacute antigeacuten PSA Dako
Serotonin SRT Dako
Somatostatin SOM Dako
S-100 S-100 Dako
Synaptofyziacuten SYN Novocastra
Tyreoglobuliacuten THG Dako
Tyreoidnyacute transkripčnyacute faktor -1 TTF-1 Dako
Vimentiacuten VIM Dako
WT1 WT1 Dako
3 Priacuteloha 3 Zoznam cytochemickyacutech farbeniacute použiacutevanyacutech na UacuteP
1 Farbenie hematoxyliacutenom-eoziacutenom
2 Farbenie podľa Giemsa ndash Romanowski
3 Farbenie podľa Papanicolaoua ndash polychroacutem EA-50 (PAP)
4 Imunocytochemickeacute vyšetrenie antigeacutenu p16 a Ki67
4 Priacuteloha 4 Zoznam použitej literatuacutery
Literatuacutera použitaacute v ŠPP OKPC01
1 Rosai and Ackerman Surgical Pathology ed Juan Rosai 9 vyd Mosby Elsevier inc 2004
2 Leverrsquos Histopathology of the Skin ed David E Elder 9 vyd Lippincott WilliamsampWilkins 2005
3 Vacek Z Histologie a histologickaacute technika 1 vyd Institut pro dalšiacute vzdělaacutevaacuteniacute pracovniacuteků ve zdravotnictviacute 1996
4 Mezinaacuterodniacute klasifikace nemociacute pro onkologii 3 vyd Světovaacute zdravotnickaacute organizace 2000
5 Pathology and Genetics of Tumours of Haematopoietic and Lymphoid Tissues ed Elaine S Jaffe Nancy Lee Harris Harald Stein James W
Vardiman IARCPress 2001
6 Pathology and Genetics of Tumours of the Breast and Female Genital Organs ed Fattaneh A Tavassoli Peter Devilee IARCPress 2003
7 Pathology and Genetics of Tumours of the Digestive System ed Stanley R Hamilton Lauri A Aaltonen IARCPress 2000
8 Pathology and Genetics of Tumours of Soft Tissue and Bone ed Christopher D M Fletcher K Krishnan Unni Fredrik Mertens IARCPress 2002
9 Pathology and Genetics of Tumours of the Urinary System and Male Genital Organs ed John N Eble Guido Sauter Jonathan I Epstein Isabell A
Sesterhenn IARCPress 2004
10 Pathology and Genetics of Tumours of the Nervous System ed Paul Kleihnes Webster K Cavenee IARCPress 2000
11 Blausteinrsquos Pathology of the Female Genital Tract ed Robert J Kurman Springer-Verlag New York 2002
12 Rosen P P Rosenrsquos Breast Pathology Lippincott WilliamsampWilkins 2001
Literatuacutera použitaacute v ŠPP OKPC02
1 Čunderliacutekovaacute M Balaacutežovaacute V Vybraneacute kapitoly z histologickej techniky Vydavateľstvo Osveta 1990 s167 ISBN 80-217-0269-9
2 Vacek Z Histologie a histologickaacute technika 1 vyd Institut pro dalšiacute vzdělaacutevaacuteniacute pracovniacuteků ve zdravotnictviacute 1996
3 Susan C Lester Manual of Surgical Pathology 2 edition Elsevier Churchill Livingstone 2006
4 Bancroft JD Gamble M Theory and practice of histological techniques Churchil-Livingstone 6th edition 2008 ISBN978-0-443-10279-0 s725
5 Callis GM Bone In Bancroft JD Gamble M Theory and practice of histological techniques Churchil-Livingstone 6th edition 2008 s333 ndash
363
Literatuacutera použitaacute v ŠPP OKPC03
1 Susan C Lester Manual of Surgical Pathology 2 edition Elsevier Churchill Livingstone 2006
2 Rosai and Ackerman Surgical Pathology ed Juan Rosai 9 vyd Mosby Elsevier inc 2004
3 Leverrsquos Histopathology of the Skin ed David E Elder 9 vyd Lippincott WilliamsampWilkins 2005
4 Vacek Z Histologie a histologickaacute technika 1 vyd Institut pro dalšiacute vzdělaacutevaacuteniacute pracovniacuteků ve zdravotnictviacute 1996
5 Mezinaacuterodniacute klasifikace nemociacute pro onkologii 3 vyd Světovaacute zdravotnickaacute organizace 2000
6 Pathology and Genetics of Tumours of Haematopoietic and Lymphoid Tissues ed Elaine S Jaffe Nancy Lee Harris Harald Stein James W
Vardiman IARCPress 2001
9 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
7 Pathology and Genetics of Tumours of the Breast and Female Genital Organs ed Fattaneh ATavassoli Peter Devilee IARCPress 2003
8 Pathology and Genetics of Tumours of the Digestive System ed Stanley R Hamilton Lauri A Aaltonen IARCPress 2000
9 Pathology and Genetics of Tumours of Soft Tissue and Bone ed Christopher D M
10 Fletcher K Krishnan Unni Fredrik Mertens IARCPress 2002
11 Pathology and Genetics of Tumours of the Urinary System and Male Genital Organs ed John N Eble Guido Sauter Jonathan I Epstein Isabell A
Sesterhenn IARCPress 2004
12 Pathology and Genetics of Tumours of the Nervous System ed Paul Kleihnes Webster K Cavenee IARCPress 2000
13 Blausteinrsquos Pathology of the Female Genital Tract ed Robert J Kurman Springer-Verlag
New York 2002
14 Rosen P P Rosenrsquos Breast Pathology Lippincott WilliamsampWilkins 2001
Literatuacutera použitaacute v ŠPP OKPC04
1 Gomolčaacutek P Zaacuteklady imunohistocheacutemie v patoloacutegii IDVPZ Brno 1997 92 s ISBN 80-7013-239-6
2 Key M et al Immunohistochemical staining methods fourth edition education guide DAKO corporatio Carpinteacuteria California 2006 174 s
3 Lukaacuteš Z Draacuteberovaacute E Feit J Vojtěšek B Imunohistochemickeacute metody v biologii a v bioptickeacute diagnostice Acta facultatis medicae Universitatis
Masarykianae Brunensis Sborniacutek praciacute LF v Brně č 112 LF Masarykovy University Brno 1997 147 s ISBN 80-210-0620-X
4 Taylor CR Cote RJ Immunomicroscopy a diagnostic tool for the surgical pathologist third edition Saunders Elsevier 2006 531 s ISBN
0721601820
5 httpwwwihcworldcom
6 httpdistdakocom
7 Shi S-R Key ME Kalra KL Antigen retrieval in formalinfixed paraffin-embedded tissues an enhancement method for immunohistochemical
staining based on microwave oven heating of tissue sections J Histochem Cytochem 1991 39(6) 741-748
8 Shi S-R Cote RJ Taylor CR Antigen retrieval immunohistochemistry past present and future J Histochem Cytochem 1997 45 (3) 327-343
9 Miller RT Technical immunohistochemistry achieving reliability and reproducibility of immunostains [online] New York Society for Applied
Immunohistochemistry Annual Meeting 2001 [cit 2008-12-12] Dostupneacute na lthttpwwwihcworldcom_booksTechnical-IHCpdfgt
Literatuacutera použitaacute v ŠPP OKPC05
1 WiedGKeebler CM Koos LG Patten SFRosenthal DL Compendium on Diagnostic Cytology
2 Richard M De May The Art and Science of Cytopathology
3 Adam P Taborskyacute L Sobek O Kolbich PCytogy of cerebrospinal fluid
4 Takahashi MColor atlas of cancer cytology
Literatuacutera použitaacute v ŠPP OKPC06
1 WiedGKeebler CM Koos LG Patten SFRosenthal DL Compendium on Diagnostic Cytology
2 Richard M De May The Art and Science of Cytopathology
3 JKobilkovaacute JSirackyacute a kolCytodiagnostika v gynekologii
4 JKobilkovaacuteZLojdaJOndrušABekovaacute Gynekologickaacute cytodiagnostika
5 JKobilkovaacute Zaacuteklady cytopatoloacutegie
10 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Flexibilnyacute rozsah akreditaacutecie
Naacutezov akreditovaneacuteho subjektu Onkologickyacute uacutestav sv Alžbety sro
Heydukova 10 812 50 Bratislava
Uacutestav laboratoacuternej mediciacuteny SZU a OUacuteSA
Oddelenie lekaacuterskej genetiky
Flexibilnyacute rozsah akreditaacutecie je zverejnenyacute na adrese
httpwwwousask_imgDocumentsDocumentyZoznam_akreditovanych_cinnostipdf
Polo
žka Objekt skuacutešky Zavedenaacute metoacuteda
Ostatneacute
špecifikaacutecie Systeacutem
Biologickyacute
materiaacutel
Analyt
Ukazovateľ
Princiacutep
Druh
Typ
Označenie
1 Analyacuteza germinatiacutevnych variantov
11
Ľudskaacute
perifeacuterna krv
-Germinatiacutevne varianty v geacutene
BRCA12
Izolaacutecia DNA
PCR
amplifikaacutecia
Sekvenačnaacute
analyacuteza
ŠPP OLG1
(dolu uved orig
praacutece)
Kvalitatiacutevna skuacuteška
12 -Germinatiacutevne varianty v geacutene RET
Izolaacutecia DNA
PCR
amplifikaacutecia
Sekvenačnaacute
analyacuteza
ŠPP OLG2
(dolu uved orig
praacutece)
13 - - Docirckaz germinatiacutevnych variantov v
geacutene MLH1 a MSH2
Izolaacutecia DNA
PCR
amplifikaacutecia
Sekvenačnaacute
analyacuteza
ŠPP OLG10
(dolu uved orig
praacutece)
14 - - Docirckaz germinatiacutevnych variantov
v geacutene VHL
Izolaacutecia DNA
PCR
amplifikaacutecia
Sekvenačnaacute
analyacuteza
SPP OLG14
(dolu uvedeneacute
origpraacutece)
15
- - Docirckaz germinatiacutevnych variantov
v paneli geacutenov asociovanyacutech
s onkologickyacutemi hereditaacuternymi
syndroacutemami
Izolaacutecia DNA
PCR
amplifikaacutecia
Sekvenačnaacute
analyacuteza
SPP OLG15
(dolu uvedeneacute
origpraacutece)
2 Analyacuteza somatickyacutech variantov
21
Fixovaneacute
natiacutevne tkanivo
- Docirckaz somatickyacutech variantov
v exoacutenoch 2 3 a 4 geacutenu KRAS a
NRAS pri naacutedoroch kolorekta
Izolaacutecia DNA
PCR
amplifikaacutecia
Mini-sekvenačnaacute
analyacuteza
Real-Time PCR
ŠPP OLG5
(dolu uved orig
praacutece)
Kvalitatiacutevna skuacuteška 22
- Docirckaz somatickyacutech variantov
v kodoacutene 600 geacutenu BRAF pri
naacutedoroch štiacutetnej žľazy a maliacutegnom
melanoacuteme
Izolaacutecia DNA
PCR
amplifikaacutecia
Mini-sekvenačnaacute
analyacuteza
Real-Time PCR
ŠPP OLG9
(dolu uved orig
praacutece)
ŠPP OLG5
(dolu uved orig
praacutece)
23
Fixovaneacute
natiacutevne
tkanivocytologi
ckeacute stery
- Docirckaz somatickyacutech variantov
v exoacutenoch 18 19 20 a 21 geacutenu
EGFR pri nemalobunkovom
karcinoacuteme pľuacutec
Izolaacutecia DNA
PCR
amplifikaacutecia
Mini-sekvenačnaacute
analyacuteza
Real-Time PCR
ŠPP OLG11
(dolu uved orig
praacutece)
ŠPP OLG5
(dolu uved orig
praacutece)
11 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Polo
žka Objekt skuacutešky Zavedenaacute metoacuteda
Ostatneacute
špecifikaacutecie Systeacutem
Biologickyacute
materiaacutel
Analyt
Ukazovateľ
Princiacutep
Druh
Typ
Označenie
24 Fixovaneacute
natiacutevne tkanivo
-Docirckaz somatickyacutech variantov
v geacutene BRCA12
Izolaacutecia DNA
PCR
amplifikaacutecia
Sekvenačnaacute
analyacuteza
Mini-skevenačnaacute
analyacuteza
ŠPP OLG16
(dolu uved orig
praacutece)
Kvalitatiacutevna skuacuteška
4 Genotypizaacutecia ľudskyacutech papilomaviacuterusov
41
Bunkovaacute
suzpenzia
fixovaneacute
tkanivo
perifeacuterna krv
-Genotypizaacutecia HPV
Izolaacutecia DNA
PCR
amplifikaacutecia
Real-Time PCR
ŠPP OLG3
(dolu uved orig
praacutece)
Kvalitatiacutevna skuacuteška
5 Docirckaz priacutetomnosti HPV
51 Bunkovaacute
suzpenzia -Docirckaz priacutetomnosti HPV
Izolaacutecia DNA
Real-Time PCR
ŠPP OLG13
(dolu uved orig
praacutece)
Kvalitatiacutevna skuacuteška
6 Docirckaz veľkyacutech geacutenovyacutech prestavieb v geacutenoch asociovanyacutech s onkologickyacutemi hereditaacuternymi syndroacutemami metoacutedou MLPA
61
Ľudskaacute
perifeacuterna krv
Fixovaneacute
natiacutevne tkanivo
- - Docirckaz veľkyacutech geacutenovyacutech
prestavieb v geacutenoch asociovanyacutech s
onkologickyacutemi hereditaacuternymi
syndroacutemami metoacutedou MLPA
Izolaacutecia DNA
PCR
amplifikaacutecia
Fragmentačnaacute
analyacuteza
SPP OLG17
(dolu uvedeneacute
origpraacutece)
Kvalitatiacutevna skuacuteška
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG1
1 Friedman L Ostermeyer E A Szabo CI a kol Confirmation of BRCA1 by analysis of germline mutations linked to breast and ovarian cancer in
ten families Nat Genetics 8 399-404 1994
2 Miki Y Katagiri T Kasumi F a kol Mutation analysis in the BRCA2 gene in primary breast cancer Nat Genetics 2 245-7 1996
3 Wagner T M U Hirtenlehner K Shen P a kol Global sequence diversity of BRCA2 analysis of 71 breast cancer families and 95 control
individuals of worldwilde populatins Hum Mol Genetocs Vol 8 No 3 1999
4 QIAamp DNA Mini Kit and OIAamp DNA Blood Mini Kit Handbook
5 Nanodrop ND 1000 useracutes manual
6 Promega Protocols and applications guide The Source for Discovery PCR cheapter Promega Corporation USA 1996
7 Amersham Pharmacia Biotech DNA Silver Staining Kit instructions
8 BigDye Terminator v 11 Cycle Sequencing Kit Protokol Applied Biosystems
9 Applied Biosystems DNA Sequencing Analysis Software Version 51 for Windows XP and 2000 Platforms User Guide Applied Biosystems
10 Applied Biosystems 31303130xl Genetic Analyzers Getting Started Guide Applied Biosystems
11 Konecny M et al Comprehensive genetic characterization of hereditary breastovarian cancer families from Slovakia Breast Cancer Res Treat
(2011) 126119ndash130
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG2
1 Ceccherini I Hofstra RMW Luo Y a kol DNA polymorphisms and conditions for SSCP analysis of the 20 exons of the RET proto-oncogene
Oncogene 9 3025-3029 1994
2 De Groot et al RET as a dignostic and therapeutic target in sporadic and hereditary endocrine tumors 2006 Endocrine Reviews 27(5) 535-560
3 Martucciello G Lerone M et al Multiple endocrine neoplasias type 2B and RET proto-oncogene Ital J Pediatr 2012 Mar 19389 doi
1011861824-7288-38-9 Review
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG3
1 Weismanovaacute E Weismann P Vizvaacuteryovaacute M a kol New approach to human high-risk papillomavirus (HR-HPV) genotyping Neoplasma 49
217-224 2002
2 Amersham Biosciences GenomicPrep Cells and Tissue DNA Isolation Kit instructions
3 Amersham Pharmacia Biotech QuickPrep Total RNA Extraction Kit instructions
4 Amersham Pharmacia Biotech Ready To Go You-Prime First-Strand Beads instructions
5 Amersham Pharmacia Biotech Ready To Go PCR Beads instructions
6 Amersham Pharmacia Biotech DNA Silver Staining Kit instructions
7 F-HPV typingTM Kit Manual
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG5
1 Van Krieken J H J M Jung A Kirchner T a kol KRAS mutation testing for predicting response to anti-EGFR therapy for colorectal carcinoma
proposal for an European quality assurance program Virchows Arch (2008) 453417-431
2 Lievre A Bachet J Le Corre D a kol KRAS mutation status is predictive of response to cetuximab therapy in colorectal cancer Cancer Res
(2006) 668
3 TheraScreen K-RAS Mutation Manual
4 BigDye Terminator v 11 Cycle Sequencing Kit Protokol Applied Biosystems
5 Applied Biosystems DNA Sequencing Analysis Software Version 51 for Windows XP and 2000 Platforms User Guide Applied Biosystems
6 Applied Biosystems 3500 Genetic Analyzers Getting Started Guide Applied Biosystems
8 SNaPshot Multiplex Kit ndash protocol and manual
12 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG9 1 Nikiforov YE thyroid carcinoma molecular pathways and therapeutic targets Modern pathology 21S37-S43 2008
2 Elisei R Ugolini C Viola D Lupi C et al BRAF V600E mutation and outcome of patients with papillary thyroid carcinoma
A 15-year median follow-up study J Clin endocrine Metab 93(10)3943-3949 2008
3 SNaPshot Multiplex Kit ndash protocol and manual Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG10
1 Brigitte Wolf Silvia Henglmueller at al Spectrum of germ-line MLH1 and MSH2 mutations in Austrian patientswith hereditary nonpolyposis
colorectal cancer The Middle European Journal of Medicine 2005 1177ndash8 269ndash277
2 Elisabeth mangold Constanze Pagenstecher et al Spectrum and frequencies of mutations in MSH2 and MLH1 identified in 1721 german families
suspected of hereditary nonpolyposis colorectal cancer Int J Cancer 2005 116 692-702
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG11
1 Rosell R Moran T Queralt C Porta R Cardenal F Camps C Majem M Lopez-Vivanco G Isla D Provencio M Insa A Massuti
B Gonzalez-Larriba J L Paz-Ares L Bover I Garcia-Campelo R Moreno M A Catot S Rolfo C Reguart N Palmero R Sanchez
JM Bastus R Mayo C Bertran- Alamillo J Molina M A Sanchez J J Taron M (2009) Screening for epidermal growth factor receptor
mutations in lung cancer N Engl J Med 361 958-967
2 Peacuterez-Soler R Chachoua A Hammond L A Rowinsky E K Huberman M Karp M Rigas J Clark G M Santabaacuterbara P Bonomi P
(2004) Determinants of Tumor Response and Survival With Erlotinib in Patients With NonndashSmall-Cell Lung Cancer Journal og Clinical
Oncology 22 16
3 Pines G Koumlstler W JYosef Yarden Department of Biological Regulation The Weizmann Institute of Science Rehovot 76100 Israel (2010)
Oncogenic mutant forms of EGFR lessons in signal transduction and targets for cancer therapy FEBSLett 584 (12) 2699ndash2706
4 ABI PRISM SnaPshot Multiplex Kit ndashProtocol and manual
5 cobasreg EGFR Mutation Test ndash User Manual
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG13
1 cobasreg 4800 HPV Test ndash Dokument č 05990343001-04SK Roche Diagnostics GmbH
2cobasreg 4800 HPV Test ndash Dokument č 05641268001-01 Roche Molecular Systems Inc
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG14
1 Nielsen SM Rhodes L Blanco I a kol 2016 Von Hippel-Lindau Disease Genetics and Role of Genetic Counseling in a Multiple Neoplasia
Syndrome J Clin Oncol 34(18)2172-2181
2 Alberta Health Services 2011 Renal cell carcinoma and genetic testing Clinical Practice Guideline GU-005
3 Chittiboina P Lonser RR 2015 Von Hippel-Lindau disease Handb Clin Neurol132139-156
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG15
1 Hereditary Cancer Solution by Sophia Genetics ndash Users guide using DNA library prep kit by Sophia genetics 48 samples
2 BRCA Hereditary Cancer MASTR Plus kit with drMID for Ilumina NGS systems ndash instructions for use
3 Crawford B Adams S B Sittler et al (2017) Multi-gene panel testing for hereditary cancer predisposition in unsolved high-risk breast and ovarian
cancer patients Breast cancer research and treatment 163(2) 383-390
4 Grissom A A Friend P J (2016) Multigene Panel Testing for Hereditary Cancer Risk Journal of the advanced practitioner in oncology 7(4) 394-
407
5 Lorans M Dow E Macrae FA Winship IM Buchanan DD (2018) Update on Hereditary Colorectal Cancer Improving the Clinical Utility of
Multigene Panel Testing Clin Colorectal Cancer 17(2)e293-e305
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG16
1 Ledermann PARP inhibitors in ovarian cancer Annals of Oncology (2016) 27 i40ndashi44
2 Koczkowska M et al Detection of somatic BRCA12 mutations in ovarian cancer - next-generation sequencing analysis of 100 cases Cancer Med
2016 Jul5(7)1640-6
3 Dougherty BA et al Biological and clinical evidence for somatic mutations in BRCA1 and BRCA2 as predictive markers for olaparib response in
high-grade serous ovarian cancers in the maintenance setting Oncotarget 2017 Jul 48(27)43653-43661
4 Maxwell KN et al BRCA locus-specific loss of heterozygosity in germline BRCA1 and BRCA2 carriers Nat Commun 2017 Aug 228(1)319
5 httpswwwagilentcomcslibrarybrochuresBrochure20Complete20solution20BRCA20MASTR20(Plus)20Dx20v1708pdf
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG17
1 MRC-Holland ndash MLPA General Protocol httpswwwmlpacom
2 Ticha I Kleibl Z Stribrna J a kol Screening for genomic rearragements in a genes in Czech high-risk breastovarian cancer patients high
proportion of population specific alterations in gene Breast Cancer Research and Treatment 2010 124 (2)337-347
3 Sluiter MD van Rensburg EJ Large genomic rearragements of the BRCA1 and BRCA2 genes review of the literature and report of a novel BRCA1
mutation Breast Cancer Research and Treatment 2011 125 325-349
Osoby spocircsobileacute modifikovať a validovať metoacutedy na Oddeleniacute lekaacuterskej genetiky
Meno a priezvisko tituly Spocircsobilosť modifikovať a validovať metoacutedy
ndash čiacuteslo položky v rozsahu akreditaacutecie
Regiacutena Lohajovaacute Behulovaacute RNDr PhD 11 až 61
Katariacutena Zaacutevodnaacute RNDr PhD 11 až 61
Ľudmila Vavrovaacute Ing PhD 11 až 61
Tomaacuteš Slamka Mgr 11 až 61
Lukaacuteš Šebest Mgr PhD 11 až 61
Aster Alemayehu RNDr PhD 11 až 61
13 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Použiteacute skratky
AGLUT ndash aglutinačnaacute reakcia
AOD ndash askorbaacutetoxidaacuteza
BRCA ndash označenie geacutenu asociovaneacuteho s dedičnou formou mamaacuternehoovariaacutelneho karcinoacutemu
CDKN2A ndash označenie geacutenu asociovaneacuteho s dedičnou formou maliacutegneho melanoacutemu
E6E7 - HPV viacuterusoveacute onkogeacuteny asociovaneacute so vznikom a progresiou Ca krčka maternice
FOTO - fotometria
GLD ndash glutamaacutetdehydrogenaacuteza
GPO ndash glycerol-3-fosfaacutet-oxidaacuteza
HPLC ndash High Performance Liquid Chromatography
HPV ndash human papillomavirus (ľudskyacute papilloma viacuterus)
CHOD ndash cholesteroloxidaacuteza
IFCC ndash International Federation for Clinical Chemistry
IMF ndash meranie fluorescencie po značeniacute buniek protilaacutetkami
KOAG ndash Coagulation Point Detection Method
KRAS ndash označenie geacutenu kt somatickeacute mutaacutecie v suacute predikatiacutevnym markerom pri metastazujuacutecom ca hrubeacuteho čreva
LATEX ndash Latex immunoassay method
MLH1 - označenie geacutenu asociovaneacuteho s dedičnou formou kolorektaacutelneho karcinoacutemu
MSH2 - označenie geacutenu asociovaneacuteho s dedičnou formou kolorektaacutelneho karcinoacutemu
NRAS ndash označenie geacutenu kt somatickeacute mutaacutecie v suacute predikatiacutevnym markerom pri metastazujuacutecom ca hrubeacuteho čreva
OHT - Oddelenie hematoloacutegie a transfuzioloacutegie
OID ndash Oddelenie imunodiagnostiky
OKB ndash Oddelenie klinickej biocheacutemie
OKIA - Oddelenie klinickej imunoloacutegie a alergoloacutegie
OKPC - Oddelenie klinickej patoloacutegie a cytoloacutegie
OLG ndash Oddelenie lekaacuterskej genetiky
PAP ndash peroxidaacuteza
PCR ndash polymeraacutezovaacute reťazovaacute reakcia
PHOTO ndash spektrofotometrickaacute metoacuteda
PLP ndash pyridoxalfosfaacutet
POD ndash peroxidaacuteza
RET ndash označenie geacutenu v dedičnej forme medulaacuterneho karcinoacutemu a syndroacutemu mnohopočetnej endokrinnej neoplaacutezie typu 2
RIA - Radio Immunoassay
RT - Real-Time
ŠPP ndash Štandardnyacute pracovnyacute postup
TPO ndash Tyreoidaacutelna peroxidaacuteza
TRACE ndash Time Resolved Amplified Cryptate Emission
3 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Polo
žka
Objekt skuacutešky Zavedenaacute metoacuteda
Ostatneacute
špecifikaacutecie Systeacutem
Biologickyacute
materiaacutel
Analyt
Ukazovateľ
Princiacutep
Druh
Typ
Označenie
5 seacuterum Uhľohydraacutet antigeacuten 19-9
(CA 19-9)
Chemiluminis-
cenčnaacute
imunoanalyacuteza
Beckman Coulter
apl list Acces GI
Monitor
(ŠPP OID5)
Sendvičoveacute imunoenzymatickeacute
stanovenie pomocou
polyklonaacutelnych protilaacutetok
6 seacuterum Voľnyacute tyroxiacuten
(FT4)
Chemiluminis-
cenčnaacute
imunoanalyacuteza
Beckman Coulter
apl list Access freeT4
(ŠPP OID6)
Dvojkrokovaacuteimunoanal chemilum
reakcia na mikročasticiach
s polyklonaacutelnou protilaacutetkou
7 seacuterum Voľnyacute trijoacutedtyroniacuten
(FT3)
Chemiluminis-
cenčnaacute
imunoanalyacuteza
Beckman Coulter
apl list Access freeT3
(ŠPP OID7)
Dvojkrokovaacuteimunoanal chemilum
reakcia na mikročasticiach
s polyklonaacutelnou protilaacutetkou
8 seacuterum Tyreotropiacuten
(TSH)
Chemiluminis-
cenčnaacute
imunoanalyacuteza
Beckman Coulter
HYPERsensitive hTSH
(ŠPP OID8)
Dvojkrokovaacute imnoanal chemilum
reakcia na mikročasticiach
s dvoma monoklonaacutelnymi
protilaacutetkami
9 seacuterum Tyreoglobuliacuten
(TG) TRACE
BRAHMS apllist TG
Kryptor
(ŠPP OID9)
Homogeacutenna sendvičovaacute
munofluoroanalyacuteza TRACE
s dvomi značenyacutemi
monoklonaacutelnymi protilaacutetkami
10 seacuterum Alfafetoproreiacuten
(AFP)
Chemiluminis-
cenčnaacute
imunoanalyacuteza
Beckman Coulter apl
list Access AFP
(ŠPP OID10)
Sendvičoveacute imunoenzymatickeacute
chemiluminiscenčneacute stanovenie
pomocou monoklonaacutelnych
protilaacutetok
11 seacuterum Choriogonadotropiacuten
(HCG)
Chemiluminis -
cenčnaacute
imunoanalyacuteza
Beckman Coulter
apl list Access total
BHCG (5th IS)
(ŠPP OID11)
Sendvičoveacute imunoenzymatickeacute
chemiluminiscenčneacute stanovenie
pomocou monoklonaacutelnych
protilaacutetok
12 seacuterum Cytokeratiacutenovyacute fragment 19
(CYFRA 21-1)
Chemiluminis-
cenčnaacute
imunoanalyacuteza
ARCHITEKT apl list
CYFRA 21-1
(ŠPP OID12)
Dvojkrokovaacute chemiluminiscenčnaacute
imunoanalyacuteza
13 seacuterum
Prostatatickyacute špecifickyacute
antigeacuten ndash celkovyacute
(PSA)
Chemiluminis-
cenčnaacute
imunoanalyacuteza
Beckman Coulter apl
list Acces
Hybritech PSA
(ŠPP OID13)
Sendvičoveacute imunoenzymatickeacute
chemiluminiscenčneacute stanovenie
pomocou monoklonaacutelnych
protilaacutetok
14 seacuterum
Prostatatickyacute špecifickyacute
antigeacuten ndash voľnyacute
(fPSA)
Chemiluminis-
cenčnaacute
imunoanalyacuteza
Beckman Coulter apl
list Acces
Hybritech freePSA
(ŠPP OID14)
Sendvičoveacute imunoenzymatickeacute
chemiluminiscenčneacute stanovenie
pomocou monoklonaacutelnych
protilaacutetok
15 seacuterum Neuroacutenšpecifickaacute enolaacuteza
(NSE) TRACE
BRAHMS apllist NSE
Kryptor
(ŠPP OID15)
Homogeacutenna sendvičovaacute
imunofluoroanalyacuteza TRACE
s dvomi značenyacutemi
monoklonaacutelnymi protilaacutetkami
16 seacuterum
Karcino-antigeacuten
skvamoacuteznych buniek
(SCC)
Chemilumini-
scenčnaacute
imunoanalyacuteza
ARCHITEKT apllist
SCC
(ŠPP OID16)
Dvojkrokovaacute imunoanal chemilum
reakcia na mikročasticiach
s dvoma monoklon protilaacutetkami
4 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Oddelenie hematoloacutegie a transfuzioloacutegie OHT Uacutestav laboratoacuternej mediciacuteny SZU a OUacuteSA
Polo
žka Objekt skuacutešky Zavedenaacute metoacuteda
Ostatneacute
špecifikaacutecie Systeacutem
Biologickyacute
materiaacutel
Analyt
Ukazovateľ
Princiacutep
DruhTyp Označenie
1 celaacute krv
v K3EDTA
Krvnyacute obraz
bez
diferenciaacutel
rozpočtu
leukocytov
+
Diferenciaacutelny
rozpočet
leukocytov z
KO
WBC
Elektrickaacute
impedancia
Prietokovaacute
cytometria
Spektro-
fotometria
Beckman Coulter DxH800
(ŠPP 11HTO)
RBC
HGB
HCT
MCV
MCH
MCHC
PLT
RDW CV
MPV
PDW
Lymfocyty
Ab počet
LYMPH
Monocyty
Ab počet
MONO
Granulocyt
NEU
Ab počet
GrNEU
Granulocyty
EO
Ab počet
GrEO
Granulocyty
BA
Ab počet
GrBA
2 celaacute krv
v K3EDTA
Krvnyacute obraz
bez
diferenciaacutel
rozpočtu
leukocytov
WBC
Elektrickaacute
impedancia
Spektro-
fotometria
Beckman Coulter DxH800
(ŠPP 10HTO)
RBC
HGB
HCT
MCV
MCH
MCHC
PLT
RDW CV
MPV
3 celaacute krv
v K3EDTA
Retikulocyty a
ich parametre
Retikulocyty Elektrickaacute
impedancia
Prietokovaacute
cytometria
Beckman Coulter DxH800
(ŠPP 15HTO)
Retik-ab poč
4 plazma
v citraacutete Na
Aktivovanyacute
parciaacutelny
tromboplastiacuteno
vyacute čas
APTT
KOAG
ACL TOP500 Sysmex CD1500 ndash
Aplikačnyacute list pre Synthasil
(ŠPP 2HTO)
APTT R
5 plazma
v citraacutete Na
Protrombiacutenovyacute
čas
QUICK
KOAG
ACL TOP500 Sysmex CD1500 ndash
Aplikačnyacute list pre RecombiPlastin 2G
(ŠPP 1HTO)
QUICK INR
6 plazma
v citraacutete Na
Trombiacutenovyacute
čas
TT
KOAG
ACL TOP500 Sysmex CD1500 ndash
Aplikačnyacute list pre Thrombin
(ŠPP 3HTO)
TT Ratio
7 plazma
v citraacutete Na Fibrinogeacuten KOAG
ACL TOP500 Sysmex CD1500 ndash
Aplikačnyacute list pre QFA Thrombin
(ŠPP 4HTO)
5 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Polo
žka Objekt skuacutešky Zavedenaacute metoacuteda
Ostatneacute
špecifikaacutecie Systeacutem
Biologickyacute
materiaacutel
Analyt
Ukazovateľ
Princiacutep
DruhTyp Označenie
8 celaacute krv
v K3EDTA Krvnaacute skupina KS+Rh(D) AGLUT
Galileo ECHO ndash ManuaacutelAplikačneacute listy
(ŠPP 22HTO)
9 plazma
v K3EDTA
Skriacutening anti-
Ery protilaacutetok
Skriacutening NAT AGLUT
Galileo ECHO ndash ManuaacutelAplikačneacute listy
(ŠPP 23HTO)
NAT-P1 AGLUT
NAT-P2 AGLUT
NAT-P3 AGLUT
10
plazma
v K3EDTA
a erytrocyty
z transfuacutezneh
o priacutepravku
Kriacutežny pokus AGLUT Galileo ECHO ndash ManuaacutelAplikačneacute listy
(ŠPP 24HTO)
11 celaacute krv
v K3EDTA
Stanovenie CD
znakov
CD3
Prietokovaacute
cytometria
Becton Dickinson FACS Canto - Manuaacutel
(ŠPP 30HTO)
IMF
CD2
CD4
CD5
CD8
CD56
CD7
CD45
CD3CD8
CD3CD4
CD10
CD19
CD20
CD23
Kappa
Lambda
KappaCD19
LambdaCD19
CD38
CD22
CD11c
CD33
CD13
CD34
CD14
HLA DR
CD16
CD15
Oddelenie klinickej imunoloacutegie a alergoloacutegie ndashOKIA Laboratoacuterium s fixnyacutem rozsahom
Polo
žka Objekt skuacutešky Zavedenaacute metoacuteda
Ostatneacute
špecifikaacutecie Systeacutem
Biologickyacute
materiaacutel
Ukazovateľ
Analyt
Parameter
Princiacutep
Druh
Typ
Označenie
1 krv Stanovenie CD
znakov
CD3 (T Lymfocyty)
CD4 (Pomocneacute T Lymfocyty)
CD8 (Cytotoxickeacute T
Lymfocyty)
CD19 (B Lymfocyty)
CD3-CD16+56 (NK bunky)
Prietokovaacute
cytometria
Becton Dickinson FACS
Canto
(ŠPP OKIA11-15)
2 krv
Stanovenie
fagocytovej
aktivity
FAGO Vyšetrenie
fagocytaacuternej aktivity
granulocytov
Prietokovaacute
cytometria
FagoFlowEx Kit Exbio
(ŠPP OKIA21)
3 seacuterum Stanovenie
celkoveacuteho IgE
IGE - Stanovenie celkoveacuteho
IgE
FEIA
(Fluorescenčnaacute
enzyacutemovaacute
imunoanalyacuteza)
ImmunoCAPreg Total IgE
(ŠPP OKIA32)
6 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Polo
žka Objekt skuacutešky Zavedenaacute metoacuteda
Ostatneacute
špecifikaacutecie Systeacutem
Biologickyacute
materiaacutel
Ukazovateľ
Analyt
Parameter
Princiacutep
Druh
Typ
Označenie
4 seacuterum Stanovenie
špecifickyacutech IgE
SIGE - Stanovenie
špecifickyacutech IgE
Enzyacutemovaacute
imunoanalyacuteza
HY-TEC Specific IgE
HYCOR
(ŠPP OKIA41)
SIGE - Stanovenie
špecifickyacutech IgE
FEIA
(Fluorescenčnaacute
enzyacutemovaacute
imunoanalyacuteza)
ImmunoCAPregSpecific
IgE Phadia
(ŠPP OKIA4 2 )
5 seacuterum
Stanovenie parametrov humoraacutelnej odpovede
Enzyacutemovaacute
imunoanalyacuteza
DSX
potravinoveacute
intolerancie
GLIAA Stanovenie protilaacutetok
triedy IgA proti gliadiacutenu
Anti-Gliadin (GAF-3X)
ELISA-(IgA) Euroimmun
(ŠPP OKIA513)
GLIAG Stanovenie protilaacutetok
triedy IgG proti gliadiacutenu
Anti-Gliadin (GAF-3X)
ELISA-(IgG) Euroimmun
(ŠPP OKIA514)
TTG A Stanovenie protilaacutetok
triedy IgA proti tkanivovej
transglutaminaacuteze
Protilaacutetky proti tkaňoveacute
transglutamnaacuteze ELISA
(IgA) Euroimmun
(ŠPP OKIA515)
ASCA Stanovenie protilaacutetok
triedy IgA proti
Saccharomyces cerevisiae
EIA Anti-ASCA IgA
AIDA
(ŠPP anti-ASCA IgA
516)
ASCAG Stanovenie
protilaacutetok triedy IgG proti
Saccharomyces cerevisiae
EIA Anti-ASCA IgG
AIDA
(ŠPP anti-ASCA IgG
517)
autoprotilaacutetky
RFC Stanovenie protilaacutetok
triedy IgA IgM IgM proti
reumatoidneacutemu faktoru
Rf-Check AIDA
(ŠPP OKIA522)
CCP Stanovenie protilaacutetok
proti cyklickeacutemu
citruliacutenoveacutemu proteiacutenu
RACP Detect AIDA
(ŠPP OKIA523)
6 seacuterum
plazma
Stanovenie
zložiek
komplementu
C1F Vyšetrenie funkčnej
aktivity C1 inhibiacutetora
Enzyacutemovaacute
imunoanalyacuteza
A003-MicroVue C1-
Inhibitor Plus EIA Kit
Quidel (ŠPP OKIA61)
Oddelenie klinickej patoloacutegie a cytoloacutegie -OKPC Uacutestav patoloacutegie SZU a OUacuteSA
Polo
žka Objekt skuacutešky Zavedenaacute metoacuteda
Ostatneacute
špecifikaacutecie Systeacutem
Biologickyacute
materiaacutel
Analyt
Ukazovateľ
Princiacutep
Druh
Typ
Označenie
Oddelenie klinickej patoloacutegie a cytoloacutegie -OKPC
1 tkanivo histopatologickeacute
zmeny
Histologickeacute
vyšetrenie tkaniva
(biopsia)
ŠPP OKPC01
ŠPP OKPC02
ŠPP OKPC03
ŠPP OKPC04
(Literatuacutera viď
priacuteloha č 4)
histoloacutegia peroperačneacute biopsie spracovanie
tvrdyacutech tkaniacutev histocheacutemia 1
imunohistocheacutemia 2 mikroskopickeacute hodnotenie
2
moč
vyacutepotok
otlačok
ascitickaacute
tekutina naacuteter
PAB (punkčnaacute
aspiračnaacute
biopsia)
cytopatologickeacute
zmeny
cytologickeacute
vyšetrenie
negynekolo-gickeacute
ŠPP OKPC05
(Literatuacutera viď
priacuteloha č 4)
farbenie naacuteterov polychromatickou metoacutedou
podľa Papanicolaua13
mikroskopickaacute diagnostika
7 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Polo
žka Objekt skuacutešky Zavedenaacute metoacuteda
Ostatneacute
špecifikaacutecie Systeacutem
Biologickyacute
materiaacutel
Analyt
Ukazovateľ
Princiacutep
Druh
Typ
Označenie
3
gynekologickyacute
ster materiaacutel
odobratyacute na
Liquid based
cytology (LBC)
cytopatologickeacute
zmeny
cytologickeacute
vyšetrenie
gynekologickeacute
Liquid based
cytology (LBC)
ŠPP OKPC06
(Literatuacutera viď
priacuteloha č 4)
farbenie naacuteterov polychromatickou metoacutedou
podľa Papanicolaua3 imunocytocheacutemia
mikroskopickaacute diagnostika
systeacutem diagnostickeacuteho hodnotenia gynekologickej
cytoloacutegie Bethesda 2001
1 Priacuteloha 1 Zoznam histochemickyacutech farbiacich a impregnačnyacutech metoacuted na OKPC UacuteP
1 Farbenie hematoxyliacutenom-eoziacutenom
2 Docirckaz polysacharidov PAS reakciou podľa Mc Manusa
3 Farbenie HP podľa Giemsu
4 Impregnaacutecia podľa Gomoriho
5 Farbenie kolageacutenvyacutech vlaacutekien podľa van Giesona
6 Docirckaz železa Perlsovou reakciou
7 Amyloid kongočerveňou podľa Puchtlerovej
8 Impregnačnaacute metoacuteda podľa Grimeliusa
9 Mallory - farbenie na fibriacuten
10 Kysleacute mukopolysacharidy - Alciaacutenovaacute modraacute
11 Farbenie na docirckaz Melaniacutenu podľa Lignaca
12 Mucikarmiacuten podľa Mayera
13 Docirckaz Mycbacterium tuberculosis podľa Ziehl-Neelsena
14 Bakteacuterie podľa Gramma
15 Docirckaz glykogeacutenu metoacutedou PAS-diastaacuteza
16 Zelenyacute Trichroacutem podľa Massona
17 Docirckaz lipidov podľa Lillieho
18 Rezorciacuten-fuchsiacuten podľa Weigerta na elastickeacute vlaacutekna
19 Docirckaz plesniacute ndash impregnačnaacute metoacuteda podľa Gomoriho
20 Kombinovanaacute metoacuteda PAS ndash Alciaacutenovaacute modraacute
2 Priacuteloha 2 Zoznam všetkyacutech antigeacutenov vyšetrovanyacutech imunohistochemickou metoacutedou na OKPC UacuteP
Protilaacutetka proti antigeacutenu Skratka Vyacuterobca
Aktiacuten (smooth muscle) ASM Dako
Alfa-1-fetoproteiacuten AFP Dako
Androgeacutenovyacute receptor AR Novocastra
Bcl-2 BCL2 Dako
Βetacatenin BCAT Dako
Caldesmon CDES Dako
Calretinin CRT Dako
CD10 CD10 Novocastra
CD20cy CD20 L26 Dako
CD30 CD30 Dako
CD31 CD31 Dako
CD34 Class II CD34 Dako
CD45 CD45 LCA Dako
CD45RO CD45RO UCHL1 Dako
CD56 CD56 Dako
CD68 CD68 Novocastra
CD99 CD99 Dako
CD117 CD117 Dako
CDX2 CDX2 Dako
Cytokeratiacuten 56 CK56 Dako
Cytokeratiacuten 7 CK7 Novocastra
Cytokeratiacuten 18 CK18 Dako
Cytokeratiacuten 19 CK19 Dako
Cytokeratiacuten 20 CK20 Novocastra
Cytokeratiacuten AE1AE3 AE13 Dako
Cytokeratiacuten HMW CKHMW Dako
Dezmiacuten DEZ Novocastra
EGFR EGFR Dako
E-kadheriacuten CAD Dako
Epitelovyacute membraacutenovyacute antigeacuten EMA Dako
Estrogeacutenovyacute receptor ER Novocastra
Gastrin GAST Dako
Glukagon GLUK Dako
Gross cystic disease fluid protein-15 GCDF Dako
Ľudskyacute choriogonadotropiacuten HCG Dako
Helicobacter pylori HP Dako
Hepatocyte HEP Dako
HER2 HER2 Dako
Chromograniacuten A CHROM Dako
8 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Inhibiacuten INH Novocastra
Inzuliacuten INZ Dako
Kalcitoniacuten KALC Dako
Kappa light chains IgK Dako
Karbonickaacute anhydraacuteza IX CAIX BioScience
Karcinoembryonaacutelny antigeacuten (monoklonaacutelna) CEA Dako
Ki-67 Ki-67 Novocastra
Lambda light chains IgL Dako
Mammaglobin MAM Dako
Melan A MELAN Dako
Melanozoacutem HMB45 Dako
Mismatch repair protein MLH1 MLH1 Novocastra
Mismatch repair protein MSH2 MSH2 Novocastra
Mismatch repair protein MSH6 MSH6 Dako
Mismatch repair protein PMS2 PMS2 Dako
Myogenin MG Dako
Enolaacuteza špecifickaacute pre neuroacuteny NSE Dako
OCT34 OCT34 Novocastra
Placentaacuterna alkalickaacute fosfataacuteza PLAP Novocastra
p16 p16 Santa Cruz Biotechnology
p53 p53 Novocastra
p63 p63 Dako
-metyl-CoA Racemaacuteza AMACR Dako
Progesteroacutenovyacute receptor PR Novocastra
Prostatickyacute špecifickyacute antigeacuten PSA Dako
Serotonin SRT Dako
Somatostatin SOM Dako
S-100 S-100 Dako
Synaptofyziacuten SYN Novocastra
Tyreoglobuliacuten THG Dako
Tyreoidnyacute transkripčnyacute faktor -1 TTF-1 Dako
Vimentiacuten VIM Dako
WT1 WT1 Dako
3 Priacuteloha 3 Zoznam cytochemickyacutech farbeniacute použiacutevanyacutech na UacuteP
1 Farbenie hematoxyliacutenom-eoziacutenom
2 Farbenie podľa Giemsa ndash Romanowski
3 Farbenie podľa Papanicolaoua ndash polychroacutem EA-50 (PAP)
4 Imunocytochemickeacute vyšetrenie antigeacutenu p16 a Ki67
4 Priacuteloha 4 Zoznam použitej literatuacutery
Literatuacutera použitaacute v ŠPP OKPC01
1 Rosai and Ackerman Surgical Pathology ed Juan Rosai 9 vyd Mosby Elsevier inc 2004
2 Leverrsquos Histopathology of the Skin ed David E Elder 9 vyd Lippincott WilliamsampWilkins 2005
3 Vacek Z Histologie a histologickaacute technika 1 vyd Institut pro dalšiacute vzdělaacutevaacuteniacute pracovniacuteků ve zdravotnictviacute 1996
4 Mezinaacuterodniacute klasifikace nemociacute pro onkologii 3 vyd Světovaacute zdravotnickaacute organizace 2000
5 Pathology and Genetics of Tumours of Haematopoietic and Lymphoid Tissues ed Elaine S Jaffe Nancy Lee Harris Harald Stein James W
Vardiman IARCPress 2001
6 Pathology and Genetics of Tumours of the Breast and Female Genital Organs ed Fattaneh A Tavassoli Peter Devilee IARCPress 2003
7 Pathology and Genetics of Tumours of the Digestive System ed Stanley R Hamilton Lauri A Aaltonen IARCPress 2000
8 Pathology and Genetics of Tumours of Soft Tissue and Bone ed Christopher D M Fletcher K Krishnan Unni Fredrik Mertens IARCPress 2002
9 Pathology and Genetics of Tumours of the Urinary System and Male Genital Organs ed John N Eble Guido Sauter Jonathan I Epstein Isabell A
Sesterhenn IARCPress 2004
10 Pathology and Genetics of Tumours of the Nervous System ed Paul Kleihnes Webster K Cavenee IARCPress 2000
11 Blausteinrsquos Pathology of the Female Genital Tract ed Robert J Kurman Springer-Verlag New York 2002
12 Rosen P P Rosenrsquos Breast Pathology Lippincott WilliamsampWilkins 2001
Literatuacutera použitaacute v ŠPP OKPC02
1 Čunderliacutekovaacute M Balaacutežovaacute V Vybraneacute kapitoly z histologickej techniky Vydavateľstvo Osveta 1990 s167 ISBN 80-217-0269-9
2 Vacek Z Histologie a histologickaacute technika 1 vyd Institut pro dalšiacute vzdělaacutevaacuteniacute pracovniacuteků ve zdravotnictviacute 1996
3 Susan C Lester Manual of Surgical Pathology 2 edition Elsevier Churchill Livingstone 2006
4 Bancroft JD Gamble M Theory and practice of histological techniques Churchil-Livingstone 6th edition 2008 ISBN978-0-443-10279-0 s725
5 Callis GM Bone In Bancroft JD Gamble M Theory and practice of histological techniques Churchil-Livingstone 6th edition 2008 s333 ndash
363
Literatuacutera použitaacute v ŠPP OKPC03
1 Susan C Lester Manual of Surgical Pathology 2 edition Elsevier Churchill Livingstone 2006
2 Rosai and Ackerman Surgical Pathology ed Juan Rosai 9 vyd Mosby Elsevier inc 2004
3 Leverrsquos Histopathology of the Skin ed David E Elder 9 vyd Lippincott WilliamsampWilkins 2005
4 Vacek Z Histologie a histologickaacute technika 1 vyd Institut pro dalšiacute vzdělaacutevaacuteniacute pracovniacuteků ve zdravotnictviacute 1996
5 Mezinaacuterodniacute klasifikace nemociacute pro onkologii 3 vyd Světovaacute zdravotnickaacute organizace 2000
6 Pathology and Genetics of Tumours of Haematopoietic and Lymphoid Tissues ed Elaine S Jaffe Nancy Lee Harris Harald Stein James W
Vardiman IARCPress 2001
9 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
7 Pathology and Genetics of Tumours of the Breast and Female Genital Organs ed Fattaneh ATavassoli Peter Devilee IARCPress 2003
8 Pathology and Genetics of Tumours of the Digestive System ed Stanley R Hamilton Lauri A Aaltonen IARCPress 2000
9 Pathology and Genetics of Tumours of Soft Tissue and Bone ed Christopher D M
10 Fletcher K Krishnan Unni Fredrik Mertens IARCPress 2002
11 Pathology and Genetics of Tumours of the Urinary System and Male Genital Organs ed John N Eble Guido Sauter Jonathan I Epstein Isabell A
Sesterhenn IARCPress 2004
12 Pathology and Genetics of Tumours of the Nervous System ed Paul Kleihnes Webster K Cavenee IARCPress 2000
13 Blausteinrsquos Pathology of the Female Genital Tract ed Robert J Kurman Springer-Verlag
New York 2002
14 Rosen P P Rosenrsquos Breast Pathology Lippincott WilliamsampWilkins 2001
Literatuacutera použitaacute v ŠPP OKPC04
1 Gomolčaacutek P Zaacuteklady imunohistocheacutemie v patoloacutegii IDVPZ Brno 1997 92 s ISBN 80-7013-239-6
2 Key M et al Immunohistochemical staining methods fourth edition education guide DAKO corporatio Carpinteacuteria California 2006 174 s
3 Lukaacuteš Z Draacuteberovaacute E Feit J Vojtěšek B Imunohistochemickeacute metody v biologii a v bioptickeacute diagnostice Acta facultatis medicae Universitatis
Masarykianae Brunensis Sborniacutek praciacute LF v Brně č 112 LF Masarykovy University Brno 1997 147 s ISBN 80-210-0620-X
4 Taylor CR Cote RJ Immunomicroscopy a diagnostic tool for the surgical pathologist third edition Saunders Elsevier 2006 531 s ISBN
0721601820
5 httpwwwihcworldcom
6 httpdistdakocom
7 Shi S-R Key ME Kalra KL Antigen retrieval in formalinfixed paraffin-embedded tissues an enhancement method for immunohistochemical
staining based on microwave oven heating of tissue sections J Histochem Cytochem 1991 39(6) 741-748
8 Shi S-R Cote RJ Taylor CR Antigen retrieval immunohistochemistry past present and future J Histochem Cytochem 1997 45 (3) 327-343
9 Miller RT Technical immunohistochemistry achieving reliability and reproducibility of immunostains [online] New York Society for Applied
Immunohistochemistry Annual Meeting 2001 [cit 2008-12-12] Dostupneacute na lthttpwwwihcworldcom_booksTechnical-IHCpdfgt
Literatuacutera použitaacute v ŠPP OKPC05
1 WiedGKeebler CM Koos LG Patten SFRosenthal DL Compendium on Diagnostic Cytology
2 Richard M De May The Art and Science of Cytopathology
3 Adam P Taborskyacute L Sobek O Kolbich PCytogy of cerebrospinal fluid
4 Takahashi MColor atlas of cancer cytology
Literatuacutera použitaacute v ŠPP OKPC06
1 WiedGKeebler CM Koos LG Patten SFRosenthal DL Compendium on Diagnostic Cytology
2 Richard M De May The Art and Science of Cytopathology
3 JKobilkovaacute JSirackyacute a kolCytodiagnostika v gynekologii
4 JKobilkovaacuteZLojdaJOndrušABekovaacute Gynekologickaacute cytodiagnostika
5 JKobilkovaacute Zaacuteklady cytopatoloacutegie
10 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Flexibilnyacute rozsah akreditaacutecie
Naacutezov akreditovaneacuteho subjektu Onkologickyacute uacutestav sv Alžbety sro
Heydukova 10 812 50 Bratislava
Uacutestav laboratoacuternej mediciacuteny SZU a OUacuteSA
Oddelenie lekaacuterskej genetiky
Flexibilnyacute rozsah akreditaacutecie je zverejnenyacute na adrese
httpwwwousask_imgDocumentsDocumentyZoznam_akreditovanych_cinnostipdf
Polo
žka Objekt skuacutešky Zavedenaacute metoacuteda
Ostatneacute
špecifikaacutecie Systeacutem
Biologickyacute
materiaacutel
Analyt
Ukazovateľ
Princiacutep
Druh
Typ
Označenie
1 Analyacuteza germinatiacutevnych variantov
11
Ľudskaacute
perifeacuterna krv
-Germinatiacutevne varianty v geacutene
BRCA12
Izolaacutecia DNA
PCR
amplifikaacutecia
Sekvenačnaacute
analyacuteza
ŠPP OLG1
(dolu uved orig
praacutece)
Kvalitatiacutevna skuacuteška
12 -Germinatiacutevne varianty v geacutene RET
Izolaacutecia DNA
PCR
amplifikaacutecia
Sekvenačnaacute
analyacuteza
ŠPP OLG2
(dolu uved orig
praacutece)
13 - - Docirckaz germinatiacutevnych variantov v
geacutene MLH1 a MSH2
Izolaacutecia DNA
PCR
amplifikaacutecia
Sekvenačnaacute
analyacuteza
ŠPP OLG10
(dolu uved orig
praacutece)
14 - - Docirckaz germinatiacutevnych variantov
v geacutene VHL
Izolaacutecia DNA
PCR
amplifikaacutecia
Sekvenačnaacute
analyacuteza
SPP OLG14
(dolu uvedeneacute
origpraacutece)
15
- - Docirckaz germinatiacutevnych variantov
v paneli geacutenov asociovanyacutech
s onkologickyacutemi hereditaacuternymi
syndroacutemami
Izolaacutecia DNA
PCR
amplifikaacutecia
Sekvenačnaacute
analyacuteza
SPP OLG15
(dolu uvedeneacute
origpraacutece)
2 Analyacuteza somatickyacutech variantov
21
Fixovaneacute
natiacutevne tkanivo
- Docirckaz somatickyacutech variantov
v exoacutenoch 2 3 a 4 geacutenu KRAS a
NRAS pri naacutedoroch kolorekta
Izolaacutecia DNA
PCR
amplifikaacutecia
Mini-sekvenačnaacute
analyacuteza
Real-Time PCR
ŠPP OLG5
(dolu uved orig
praacutece)
Kvalitatiacutevna skuacuteška 22
- Docirckaz somatickyacutech variantov
v kodoacutene 600 geacutenu BRAF pri
naacutedoroch štiacutetnej žľazy a maliacutegnom
melanoacuteme
Izolaacutecia DNA
PCR
amplifikaacutecia
Mini-sekvenačnaacute
analyacuteza
Real-Time PCR
ŠPP OLG9
(dolu uved orig
praacutece)
ŠPP OLG5
(dolu uved orig
praacutece)
23
Fixovaneacute
natiacutevne
tkanivocytologi
ckeacute stery
- Docirckaz somatickyacutech variantov
v exoacutenoch 18 19 20 a 21 geacutenu
EGFR pri nemalobunkovom
karcinoacuteme pľuacutec
Izolaacutecia DNA
PCR
amplifikaacutecia
Mini-sekvenačnaacute
analyacuteza
Real-Time PCR
ŠPP OLG11
(dolu uved orig
praacutece)
ŠPP OLG5
(dolu uved orig
praacutece)
11 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Polo
žka Objekt skuacutešky Zavedenaacute metoacuteda
Ostatneacute
špecifikaacutecie Systeacutem
Biologickyacute
materiaacutel
Analyt
Ukazovateľ
Princiacutep
Druh
Typ
Označenie
24 Fixovaneacute
natiacutevne tkanivo
-Docirckaz somatickyacutech variantov
v geacutene BRCA12
Izolaacutecia DNA
PCR
amplifikaacutecia
Sekvenačnaacute
analyacuteza
Mini-skevenačnaacute
analyacuteza
ŠPP OLG16
(dolu uved orig
praacutece)
Kvalitatiacutevna skuacuteška
4 Genotypizaacutecia ľudskyacutech papilomaviacuterusov
41
Bunkovaacute
suzpenzia
fixovaneacute
tkanivo
perifeacuterna krv
-Genotypizaacutecia HPV
Izolaacutecia DNA
PCR
amplifikaacutecia
Real-Time PCR
ŠPP OLG3
(dolu uved orig
praacutece)
Kvalitatiacutevna skuacuteška
5 Docirckaz priacutetomnosti HPV
51 Bunkovaacute
suzpenzia -Docirckaz priacutetomnosti HPV
Izolaacutecia DNA
Real-Time PCR
ŠPP OLG13
(dolu uved orig
praacutece)
Kvalitatiacutevna skuacuteška
6 Docirckaz veľkyacutech geacutenovyacutech prestavieb v geacutenoch asociovanyacutech s onkologickyacutemi hereditaacuternymi syndroacutemami metoacutedou MLPA
61
Ľudskaacute
perifeacuterna krv
Fixovaneacute
natiacutevne tkanivo
- - Docirckaz veľkyacutech geacutenovyacutech
prestavieb v geacutenoch asociovanyacutech s
onkologickyacutemi hereditaacuternymi
syndroacutemami metoacutedou MLPA
Izolaacutecia DNA
PCR
amplifikaacutecia
Fragmentačnaacute
analyacuteza
SPP OLG17
(dolu uvedeneacute
origpraacutece)
Kvalitatiacutevna skuacuteška
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG1
1 Friedman L Ostermeyer E A Szabo CI a kol Confirmation of BRCA1 by analysis of germline mutations linked to breast and ovarian cancer in
ten families Nat Genetics 8 399-404 1994
2 Miki Y Katagiri T Kasumi F a kol Mutation analysis in the BRCA2 gene in primary breast cancer Nat Genetics 2 245-7 1996
3 Wagner T M U Hirtenlehner K Shen P a kol Global sequence diversity of BRCA2 analysis of 71 breast cancer families and 95 control
individuals of worldwilde populatins Hum Mol Genetocs Vol 8 No 3 1999
4 QIAamp DNA Mini Kit and OIAamp DNA Blood Mini Kit Handbook
5 Nanodrop ND 1000 useracutes manual
6 Promega Protocols and applications guide The Source for Discovery PCR cheapter Promega Corporation USA 1996
7 Amersham Pharmacia Biotech DNA Silver Staining Kit instructions
8 BigDye Terminator v 11 Cycle Sequencing Kit Protokol Applied Biosystems
9 Applied Biosystems DNA Sequencing Analysis Software Version 51 for Windows XP and 2000 Platforms User Guide Applied Biosystems
10 Applied Biosystems 31303130xl Genetic Analyzers Getting Started Guide Applied Biosystems
11 Konecny M et al Comprehensive genetic characterization of hereditary breastovarian cancer families from Slovakia Breast Cancer Res Treat
(2011) 126119ndash130
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG2
1 Ceccherini I Hofstra RMW Luo Y a kol DNA polymorphisms and conditions for SSCP analysis of the 20 exons of the RET proto-oncogene
Oncogene 9 3025-3029 1994
2 De Groot et al RET as a dignostic and therapeutic target in sporadic and hereditary endocrine tumors 2006 Endocrine Reviews 27(5) 535-560
3 Martucciello G Lerone M et al Multiple endocrine neoplasias type 2B and RET proto-oncogene Ital J Pediatr 2012 Mar 19389 doi
1011861824-7288-38-9 Review
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG3
1 Weismanovaacute E Weismann P Vizvaacuteryovaacute M a kol New approach to human high-risk papillomavirus (HR-HPV) genotyping Neoplasma 49
217-224 2002
2 Amersham Biosciences GenomicPrep Cells and Tissue DNA Isolation Kit instructions
3 Amersham Pharmacia Biotech QuickPrep Total RNA Extraction Kit instructions
4 Amersham Pharmacia Biotech Ready To Go You-Prime First-Strand Beads instructions
5 Amersham Pharmacia Biotech Ready To Go PCR Beads instructions
6 Amersham Pharmacia Biotech DNA Silver Staining Kit instructions
7 F-HPV typingTM Kit Manual
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG5
1 Van Krieken J H J M Jung A Kirchner T a kol KRAS mutation testing for predicting response to anti-EGFR therapy for colorectal carcinoma
proposal for an European quality assurance program Virchows Arch (2008) 453417-431
2 Lievre A Bachet J Le Corre D a kol KRAS mutation status is predictive of response to cetuximab therapy in colorectal cancer Cancer Res
(2006) 668
3 TheraScreen K-RAS Mutation Manual
4 BigDye Terminator v 11 Cycle Sequencing Kit Protokol Applied Biosystems
5 Applied Biosystems DNA Sequencing Analysis Software Version 51 for Windows XP and 2000 Platforms User Guide Applied Biosystems
6 Applied Biosystems 3500 Genetic Analyzers Getting Started Guide Applied Biosystems
8 SNaPshot Multiplex Kit ndash protocol and manual
12 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG9 1 Nikiforov YE thyroid carcinoma molecular pathways and therapeutic targets Modern pathology 21S37-S43 2008
2 Elisei R Ugolini C Viola D Lupi C et al BRAF V600E mutation and outcome of patients with papillary thyroid carcinoma
A 15-year median follow-up study J Clin endocrine Metab 93(10)3943-3949 2008
3 SNaPshot Multiplex Kit ndash protocol and manual Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG10
1 Brigitte Wolf Silvia Henglmueller at al Spectrum of germ-line MLH1 and MSH2 mutations in Austrian patientswith hereditary nonpolyposis
colorectal cancer The Middle European Journal of Medicine 2005 1177ndash8 269ndash277
2 Elisabeth mangold Constanze Pagenstecher et al Spectrum and frequencies of mutations in MSH2 and MLH1 identified in 1721 german families
suspected of hereditary nonpolyposis colorectal cancer Int J Cancer 2005 116 692-702
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG11
1 Rosell R Moran T Queralt C Porta R Cardenal F Camps C Majem M Lopez-Vivanco G Isla D Provencio M Insa A Massuti
B Gonzalez-Larriba J L Paz-Ares L Bover I Garcia-Campelo R Moreno M A Catot S Rolfo C Reguart N Palmero R Sanchez
JM Bastus R Mayo C Bertran- Alamillo J Molina M A Sanchez J J Taron M (2009) Screening for epidermal growth factor receptor
mutations in lung cancer N Engl J Med 361 958-967
2 Peacuterez-Soler R Chachoua A Hammond L A Rowinsky E K Huberman M Karp M Rigas J Clark G M Santabaacuterbara P Bonomi P
(2004) Determinants of Tumor Response and Survival With Erlotinib in Patients With NonndashSmall-Cell Lung Cancer Journal og Clinical
Oncology 22 16
3 Pines G Koumlstler W JYosef Yarden Department of Biological Regulation The Weizmann Institute of Science Rehovot 76100 Israel (2010)
Oncogenic mutant forms of EGFR lessons in signal transduction and targets for cancer therapy FEBSLett 584 (12) 2699ndash2706
4 ABI PRISM SnaPshot Multiplex Kit ndashProtocol and manual
5 cobasreg EGFR Mutation Test ndash User Manual
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG13
1 cobasreg 4800 HPV Test ndash Dokument č 05990343001-04SK Roche Diagnostics GmbH
2cobasreg 4800 HPV Test ndash Dokument č 05641268001-01 Roche Molecular Systems Inc
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG14
1 Nielsen SM Rhodes L Blanco I a kol 2016 Von Hippel-Lindau Disease Genetics and Role of Genetic Counseling in a Multiple Neoplasia
Syndrome J Clin Oncol 34(18)2172-2181
2 Alberta Health Services 2011 Renal cell carcinoma and genetic testing Clinical Practice Guideline GU-005
3 Chittiboina P Lonser RR 2015 Von Hippel-Lindau disease Handb Clin Neurol132139-156
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG15
1 Hereditary Cancer Solution by Sophia Genetics ndash Users guide using DNA library prep kit by Sophia genetics 48 samples
2 BRCA Hereditary Cancer MASTR Plus kit with drMID for Ilumina NGS systems ndash instructions for use
3 Crawford B Adams S B Sittler et al (2017) Multi-gene panel testing for hereditary cancer predisposition in unsolved high-risk breast and ovarian
cancer patients Breast cancer research and treatment 163(2) 383-390
4 Grissom A A Friend P J (2016) Multigene Panel Testing for Hereditary Cancer Risk Journal of the advanced practitioner in oncology 7(4) 394-
407
5 Lorans M Dow E Macrae FA Winship IM Buchanan DD (2018) Update on Hereditary Colorectal Cancer Improving the Clinical Utility of
Multigene Panel Testing Clin Colorectal Cancer 17(2)e293-e305
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG16
1 Ledermann PARP inhibitors in ovarian cancer Annals of Oncology (2016) 27 i40ndashi44
2 Koczkowska M et al Detection of somatic BRCA12 mutations in ovarian cancer - next-generation sequencing analysis of 100 cases Cancer Med
2016 Jul5(7)1640-6
3 Dougherty BA et al Biological and clinical evidence for somatic mutations in BRCA1 and BRCA2 as predictive markers for olaparib response in
high-grade serous ovarian cancers in the maintenance setting Oncotarget 2017 Jul 48(27)43653-43661
4 Maxwell KN et al BRCA locus-specific loss of heterozygosity in germline BRCA1 and BRCA2 carriers Nat Commun 2017 Aug 228(1)319
5 httpswwwagilentcomcslibrarybrochuresBrochure20Complete20solution20BRCA20MASTR20(Plus)20Dx20v1708pdf
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG17
1 MRC-Holland ndash MLPA General Protocol httpswwwmlpacom
2 Ticha I Kleibl Z Stribrna J a kol Screening for genomic rearragements in a genes in Czech high-risk breastovarian cancer patients high
proportion of population specific alterations in gene Breast Cancer Research and Treatment 2010 124 (2)337-347
3 Sluiter MD van Rensburg EJ Large genomic rearragements of the BRCA1 and BRCA2 genes review of the literature and report of a novel BRCA1
mutation Breast Cancer Research and Treatment 2011 125 325-349
Osoby spocircsobileacute modifikovať a validovať metoacutedy na Oddeleniacute lekaacuterskej genetiky
Meno a priezvisko tituly Spocircsobilosť modifikovať a validovať metoacutedy
ndash čiacuteslo položky v rozsahu akreditaacutecie
Regiacutena Lohajovaacute Behulovaacute RNDr PhD 11 až 61
Katariacutena Zaacutevodnaacute RNDr PhD 11 až 61
Ľudmila Vavrovaacute Ing PhD 11 až 61
Tomaacuteš Slamka Mgr 11 až 61
Lukaacuteš Šebest Mgr PhD 11 až 61
Aster Alemayehu RNDr PhD 11 až 61
13 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Použiteacute skratky
AGLUT ndash aglutinačnaacute reakcia
AOD ndash askorbaacutetoxidaacuteza
BRCA ndash označenie geacutenu asociovaneacuteho s dedičnou formou mamaacuternehoovariaacutelneho karcinoacutemu
CDKN2A ndash označenie geacutenu asociovaneacuteho s dedičnou formou maliacutegneho melanoacutemu
E6E7 - HPV viacuterusoveacute onkogeacuteny asociovaneacute so vznikom a progresiou Ca krčka maternice
FOTO - fotometria
GLD ndash glutamaacutetdehydrogenaacuteza
GPO ndash glycerol-3-fosfaacutet-oxidaacuteza
HPLC ndash High Performance Liquid Chromatography
HPV ndash human papillomavirus (ľudskyacute papilloma viacuterus)
CHOD ndash cholesteroloxidaacuteza
IFCC ndash International Federation for Clinical Chemistry
IMF ndash meranie fluorescencie po značeniacute buniek protilaacutetkami
KOAG ndash Coagulation Point Detection Method
KRAS ndash označenie geacutenu kt somatickeacute mutaacutecie v suacute predikatiacutevnym markerom pri metastazujuacutecom ca hrubeacuteho čreva
LATEX ndash Latex immunoassay method
MLH1 - označenie geacutenu asociovaneacuteho s dedičnou formou kolorektaacutelneho karcinoacutemu
MSH2 - označenie geacutenu asociovaneacuteho s dedičnou formou kolorektaacutelneho karcinoacutemu
NRAS ndash označenie geacutenu kt somatickeacute mutaacutecie v suacute predikatiacutevnym markerom pri metastazujuacutecom ca hrubeacuteho čreva
OHT - Oddelenie hematoloacutegie a transfuzioloacutegie
OID ndash Oddelenie imunodiagnostiky
OKB ndash Oddelenie klinickej biocheacutemie
OKIA - Oddelenie klinickej imunoloacutegie a alergoloacutegie
OKPC - Oddelenie klinickej patoloacutegie a cytoloacutegie
OLG ndash Oddelenie lekaacuterskej genetiky
PAP ndash peroxidaacuteza
PCR ndash polymeraacutezovaacute reťazovaacute reakcia
PHOTO ndash spektrofotometrickaacute metoacuteda
PLP ndash pyridoxalfosfaacutet
POD ndash peroxidaacuteza
RET ndash označenie geacutenu v dedičnej forme medulaacuterneho karcinoacutemu a syndroacutemu mnohopočetnej endokrinnej neoplaacutezie typu 2
RIA - Radio Immunoassay
RT - Real-Time
ŠPP ndash Štandardnyacute pracovnyacute postup
TPO ndash Tyreoidaacutelna peroxidaacuteza
TRACE ndash Time Resolved Amplified Cryptate Emission
4 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Oddelenie hematoloacutegie a transfuzioloacutegie OHT Uacutestav laboratoacuternej mediciacuteny SZU a OUacuteSA
Polo
žka Objekt skuacutešky Zavedenaacute metoacuteda
Ostatneacute
špecifikaacutecie Systeacutem
Biologickyacute
materiaacutel
Analyt
Ukazovateľ
Princiacutep
DruhTyp Označenie
1 celaacute krv
v K3EDTA
Krvnyacute obraz
bez
diferenciaacutel
rozpočtu
leukocytov
+
Diferenciaacutelny
rozpočet
leukocytov z
KO
WBC
Elektrickaacute
impedancia
Prietokovaacute
cytometria
Spektro-
fotometria
Beckman Coulter DxH800
(ŠPP 11HTO)
RBC
HGB
HCT
MCV
MCH
MCHC
PLT
RDW CV
MPV
PDW
Lymfocyty
Ab počet
LYMPH
Monocyty
Ab počet
MONO
Granulocyt
NEU
Ab počet
GrNEU
Granulocyty
EO
Ab počet
GrEO
Granulocyty
BA
Ab počet
GrBA
2 celaacute krv
v K3EDTA
Krvnyacute obraz
bez
diferenciaacutel
rozpočtu
leukocytov
WBC
Elektrickaacute
impedancia
Spektro-
fotometria
Beckman Coulter DxH800
(ŠPP 10HTO)
RBC
HGB
HCT
MCV
MCH
MCHC
PLT
RDW CV
MPV
3 celaacute krv
v K3EDTA
Retikulocyty a
ich parametre
Retikulocyty Elektrickaacute
impedancia
Prietokovaacute
cytometria
Beckman Coulter DxH800
(ŠPP 15HTO)
Retik-ab poč
4 plazma
v citraacutete Na
Aktivovanyacute
parciaacutelny
tromboplastiacuteno
vyacute čas
APTT
KOAG
ACL TOP500 Sysmex CD1500 ndash
Aplikačnyacute list pre Synthasil
(ŠPP 2HTO)
APTT R
5 plazma
v citraacutete Na
Protrombiacutenovyacute
čas
QUICK
KOAG
ACL TOP500 Sysmex CD1500 ndash
Aplikačnyacute list pre RecombiPlastin 2G
(ŠPP 1HTO)
QUICK INR
6 plazma
v citraacutete Na
Trombiacutenovyacute
čas
TT
KOAG
ACL TOP500 Sysmex CD1500 ndash
Aplikačnyacute list pre Thrombin
(ŠPP 3HTO)
TT Ratio
7 plazma
v citraacutete Na Fibrinogeacuten KOAG
ACL TOP500 Sysmex CD1500 ndash
Aplikačnyacute list pre QFA Thrombin
(ŠPP 4HTO)
5 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Polo
žka Objekt skuacutešky Zavedenaacute metoacuteda
Ostatneacute
špecifikaacutecie Systeacutem
Biologickyacute
materiaacutel
Analyt
Ukazovateľ
Princiacutep
DruhTyp Označenie
8 celaacute krv
v K3EDTA Krvnaacute skupina KS+Rh(D) AGLUT
Galileo ECHO ndash ManuaacutelAplikačneacute listy
(ŠPP 22HTO)
9 plazma
v K3EDTA
Skriacutening anti-
Ery protilaacutetok
Skriacutening NAT AGLUT
Galileo ECHO ndash ManuaacutelAplikačneacute listy
(ŠPP 23HTO)
NAT-P1 AGLUT
NAT-P2 AGLUT
NAT-P3 AGLUT
10
plazma
v K3EDTA
a erytrocyty
z transfuacutezneh
o priacutepravku
Kriacutežny pokus AGLUT Galileo ECHO ndash ManuaacutelAplikačneacute listy
(ŠPP 24HTO)
11 celaacute krv
v K3EDTA
Stanovenie CD
znakov
CD3
Prietokovaacute
cytometria
Becton Dickinson FACS Canto - Manuaacutel
(ŠPP 30HTO)
IMF
CD2
CD4
CD5
CD8
CD56
CD7
CD45
CD3CD8
CD3CD4
CD10
CD19
CD20
CD23
Kappa
Lambda
KappaCD19
LambdaCD19
CD38
CD22
CD11c
CD33
CD13
CD34
CD14
HLA DR
CD16
CD15
Oddelenie klinickej imunoloacutegie a alergoloacutegie ndashOKIA Laboratoacuterium s fixnyacutem rozsahom
Polo
žka Objekt skuacutešky Zavedenaacute metoacuteda
Ostatneacute
špecifikaacutecie Systeacutem
Biologickyacute
materiaacutel
Ukazovateľ
Analyt
Parameter
Princiacutep
Druh
Typ
Označenie
1 krv Stanovenie CD
znakov
CD3 (T Lymfocyty)
CD4 (Pomocneacute T Lymfocyty)
CD8 (Cytotoxickeacute T
Lymfocyty)
CD19 (B Lymfocyty)
CD3-CD16+56 (NK bunky)
Prietokovaacute
cytometria
Becton Dickinson FACS
Canto
(ŠPP OKIA11-15)
2 krv
Stanovenie
fagocytovej
aktivity
FAGO Vyšetrenie
fagocytaacuternej aktivity
granulocytov
Prietokovaacute
cytometria
FagoFlowEx Kit Exbio
(ŠPP OKIA21)
3 seacuterum Stanovenie
celkoveacuteho IgE
IGE - Stanovenie celkoveacuteho
IgE
FEIA
(Fluorescenčnaacute
enzyacutemovaacute
imunoanalyacuteza)
ImmunoCAPreg Total IgE
(ŠPP OKIA32)
6 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Polo
žka Objekt skuacutešky Zavedenaacute metoacuteda
Ostatneacute
špecifikaacutecie Systeacutem
Biologickyacute
materiaacutel
Ukazovateľ
Analyt
Parameter
Princiacutep
Druh
Typ
Označenie
4 seacuterum Stanovenie
špecifickyacutech IgE
SIGE - Stanovenie
špecifickyacutech IgE
Enzyacutemovaacute
imunoanalyacuteza
HY-TEC Specific IgE
HYCOR
(ŠPP OKIA41)
SIGE - Stanovenie
špecifickyacutech IgE
FEIA
(Fluorescenčnaacute
enzyacutemovaacute
imunoanalyacuteza)
ImmunoCAPregSpecific
IgE Phadia
(ŠPP OKIA4 2 )
5 seacuterum
Stanovenie parametrov humoraacutelnej odpovede
Enzyacutemovaacute
imunoanalyacuteza
DSX
potravinoveacute
intolerancie
GLIAA Stanovenie protilaacutetok
triedy IgA proti gliadiacutenu
Anti-Gliadin (GAF-3X)
ELISA-(IgA) Euroimmun
(ŠPP OKIA513)
GLIAG Stanovenie protilaacutetok
triedy IgG proti gliadiacutenu
Anti-Gliadin (GAF-3X)
ELISA-(IgG) Euroimmun
(ŠPP OKIA514)
TTG A Stanovenie protilaacutetok
triedy IgA proti tkanivovej
transglutaminaacuteze
Protilaacutetky proti tkaňoveacute
transglutamnaacuteze ELISA
(IgA) Euroimmun
(ŠPP OKIA515)
ASCA Stanovenie protilaacutetok
triedy IgA proti
Saccharomyces cerevisiae
EIA Anti-ASCA IgA
AIDA
(ŠPP anti-ASCA IgA
516)
ASCAG Stanovenie
protilaacutetok triedy IgG proti
Saccharomyces cerevisiae
EIA Anti-ASCA IgG
AIDA
(ŠPP anti-ASCA IgG
517)
autoprotilaacutetky
RFC Stanovenie protilaacutetok
triedy IgA IgM IgM proti
reumatoidneacutemu faktoru
Rf-Check AIDA
(ŠPP OKIA522)
CCP Stanovenie protilaacutetok
proti cyklickeacutemu
citruliacutenoveacutemu proteiacutenu
RACP Detect AIDA
(ŠPP OKIA523)
6 seacuterum
plazma
Stanovenie
zložiek
komplementu
C1F Vyšetrenie funkčnej
aktivity C1 inhibiacutetora
Enzyacutemovaacute
imunoanalyacuteza
A003-MicroVue C1-
Inhibitor Plus EIA Kit
Quidel (ŠPP OKIA61)
Oddelenie klinickej patoloacutegie a cytoloacutegie -OKPC Uacutestav patoloacutegie SZU a OUacuteSA
Polo
žka Objekt skuacutešky Zavedenaacute metoacuteda
Ostatneacute
špecifikaacutecie Systeacutem
Biologickyacute
materiaacutel
Analyt
Ukazovateľ
Princiacutep
Druh
Typ
Označenie
Oddelenie klinickej patoloacutegie a cytoloacutegie -OKPC
1 tkanivo histopatologickeacute
zmeny
Histologickeacute
vyšetrenie tkaniva
(biopsia)
ŠPP OKPC01
ŠPP OKPC02
ŠPP OKPC03
ŠPP OKPC04
(Literatuacutera viď
priacuteloha č 4)
histoloacutegia peroperačneacute biopsie spracovanie
tvrdyacutech tkaniacutev histocheacutemia 1
imunohistocheacutemia 2 mikroskopickeacute hodnotenie
2
moč
vyacutepotok
otlačok
ascitickaacute
tekutina naacuteter
PAB (punkčnaacute
aspiračnaacute
biopsia)
cytopatologickeacute
zmeny
cytologickeacute
vyšetrenie
negynekolo-gickeacute
ŠPP OKPC05
(Literatuacutera viď
priacuteloha č 4)
farbenie naacuteterov polychromatickou metoacutedou
podľa Papanicolaua13
mikroskopickaacute diagnostika
7 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Polo
žka Objekt skuacutešky Zavedenaacute metoacuteda
Ostatneacute
špecifikaacutecie Systeacutem
Biologickyacute
materiaacutel
Analyt
Ukazovateľ
Princiacutep
Druh
Typ
Označenie
3
gynekologickyacute
ster materiaacutel
odobratyacute na
Liquid based
cytology (LBC)
cytopatologickeacute
zmeny
cytologickeacute
vyšetrenie
gynekologickeacute
Liquid based
cytology (LBC)
ŠPP OKPC06
(Literatuacutera viď
priacuteloha č 4)
farbenie naacuteterov polychromatickou metoacutedou
podľa Papanicolaua3 imunocytocheacutemia
mikroskopickaacute diagnostika
systeacutem diagnostickeacuteho hodnotenia gynekologickej
cytoloacutegie Bethesda 2001
1 Priacuteloha 1 Zoznam histochemickyacutech farbiacich a impregnačnyacutech metoacuted na OKPC UacuteP
1 Farbenie hematoxyliacutenom-eoziacutenom
2 Docirckaz polysacharidov PAS reakciou podľa Mc Manusa
3 Farbenie HP podľa Giemsu
4 Impregnaacutecia podľa Gomoriho
5 Farbenie kolageacutenvyacutech vlaacutekien podľa van Giesona
6 Docirckaz železa Perlsovou reakciou
7 Amyloid kongočerveňou podľa Puchtlerovej
8 Impregnačnaacute metoacuteda podľa Grimeliusa
9 Mallory - farbenie na fibriacuten
10 Kysleacute mukopolysacharidy - Alciaacutenovaacute modraacute
11 Farbenie na docirckaz Melaniacutenu podľa Lignaca
12 Mucikarmiacuten podľa Mayera
13 Docirckaz Mycbacterium tuberculosis podľa Ziehl-Neelsena
14 Bakteacuterie podľa Gramma
15 Docirckaz glykogeacutenu metoacutedou PAS-diastaacuteza
16 Zelenyacute Trichroacutem podľa Massona
17 Docirckaz lipidov podľa Lillieho
18 Rezorciacuten-fuchsiacuten podľa Weigerta na elastickeacute vlaacutekna
19 Docirckaz plesniacute ndash impregnačnaacute metoacuteda podľa Gomoriho
20 Kombinovanaacute metoacuteda PAS ndash Alciaacutenovaacute modraacute
2 Priacuteloha 2 Zoznam všetkyacutech antigeacutenov vyšetrovanyacutech imunohistochemickou metoacutedou na OKPC UacuteP
Protilaacutetka proti antigeacutenu Skratka Vyacuterobca
Aktiacuten (smooth muscle) ASM Dako
Alfa-1-fetoproteiacuten AFP Dako
Androgeacutenovyacute receptor AR Novocastra
Bcl-2 BCL2 Dako
Βetacatenin BCAT Dako
Caldesmon CDES Dako
Calretinin CRT Dako
CD10 CD10 Novocastra
CD20cy CD20 L26 Dako
CD30 CD30 Dako
CD31 CD31 Dako
CD34 Class II CD34 Dako
CD45 CD45 LCA Dako
CD45RO CD45RO UCHL1 Dako
CD56 CD56 Dako
CD68 CD68 Novocastra
CD99 CD99 Dako
CD117 CD117 Dako
CDX2 CDX2 Dako
Cytokeratiacuten 56 CK56 Dako
Cytokeratiacuten 7 CK7 Novocastra
Cytokeratiacuten 18 CK18 Dako
Cytokeratiacuten 19 CK19 Dako
Cytokeratiacuten 20 CK20 Novocastra
Cytokeratiacuten AE1AE3 AE13 Dako
Cytokeratiacuten HMW CKHMW Dako
Dezmiacuten DEZ Novocastra
EGFR EGFR Dako
E-kadheriacuten CAD Dako
Epitelovyacute membraacutenovyacute antigeacuten EMA Dako
Estrogeacutenovyacute receptor ER Novocastra
Gastrin GAST Dako
Glukagon GLUK Dako
Gross cystic disease fluid protein-15 GCDF Dako
Ľudskyacute choriogonadotropiacuten HCG Dako
Helicobacter pylori HP Dako
Hepatocyte HEP Dako
HER2 HER2 Dako
Chromograniacuten A CHROM Dako
8 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Inhibiacuten INH Novocastra
Inzuliacuten INZ Dako
Kalcitoniacuten KALC Dako
Kappa light chains IgK Dako
Karbonickaacute anhydraacuteza IX CAIX BioScience
Karcinoembryonaacutelny antigeacuten (monoklonaacutelna) CEA Dako
Ki-67 Ki-67 Novocastra
Lambda light chains IgL Dako
Mammaglobin MAM Dako
Melan A MELAN Dako
Melanozoacutem HMB45 Dako
Mismatch repair protein MLH1 MLH1 Novocastra
Mismatch repair protein MSH2 MSH2 Novocastra
Mismatch repair protein MSH6 MSH6 Dako
Mismatch repair protein PMS2 PMS2 Dako
Myogenin MG Dako
Enolaacuteza špecifickaacute pre neuroacuteny NSE Dako
OCT34 OCT34 Novocastra
Placentaacuterna alkalickaacute fosfataacuteza PLAP Novocastra
p16 p16 Santa Cruz Biotechnology
p53 p53 Novocastra
p63 p63 Dako
-metyl-CoA Racemaacuteza AMACR Dako
Progesteroacutenovyacute receptor PR Novocastra
Prostatickyacute špecifickyacute antigeacuten PSA Dako
Serotonin SRT Dako
Somatostatin SOM Dako
S-100 S-100 Dako
Synaptofyziacuten SYN Novocastra
Tyreoglobuliacuten THG Dako
Tyreoidnyacute transkripčnyacute faktor -1 TTF-1 Dako
Vimentiacuten VIM Dako
WT1 WT1 Dako
3 Priacuteloha 3 Zoznam cytochemickyacutech farbeniacute použiacutevanyacutech na UacuteP
1 Farbenie hematoxyliacutenom-eoziacutenom
2 Farbenie podľa Giemsa ndash Romanowski
3 Farbenie podľa Papanicolaoua ndash polychroacutem EA-50 (PAP)
4 Imunocytochemickeacute vyšetrenie antigeacutenu p16 a Ki67
4 Priacuteloha 4 Zoznam použitej literatuacutery
Literatuacutera použitaacute v ŠPP OKPC01
1 Rosai and Ackerman Surgical Pathology ed Juan Rosai 9 vyd Mosby Elsevier inc 2004
2 Leverrsquos Histopathology of the Skin ed David E Elder 9 vyd Lippincott WilliamsampWilkins 2005
3 Vacek Z Histologie a histologickaacute technika 1 vyd Institut pro dalšiacute vzdělaacutevaacuteniacute pracovniacuteků ve zdravotnictviacute 1996
4 Mezinaacuterodniacute klasifikace nemociacute pro onkologii 3 vyd Světovaacute zdravotnickaacute organizace 2000
5 Pathology and Genetics of Tumours of Haematopoietic and Lymphoid Tissues ed Elaine S Jaffe Nancy Lee Harris Harald Stein James W
Vardiman IARCPress 2001
6 Pathology and Genetics of Tumours of the Breast and Female Genital Organs ed Fattaneh A Tavassoli Peter Devilee IARCPress 2003
7 Pathology and Genetics of Tumours of the Digestive System ed Stanley R Hamilton Lauri A Aaltonen IARCPress 2000
8 Pathology and Genetics of Tumours of Soft Tissue and Bone ed Christopher D M Fletcher K Krishnan Unni Fredrik Mertens IARCPress 2002
9 Pathology and Genetics of Tumours of the Urinary System and Male Genital Organs ed John N Eble Guido Sauter Jonathan I Epstein Isabell A
Sesterhenn IARCPress 2004
10 Pathology and Genetics of Tumours of the Nervous System ed Paul Kleihnes Webster K Cavenee IARCPress 2000
11 Blausteinrsquos Pathology of the Female Genital Tract ed Robert J Kurman Springer-Verlag New York 2002
12 Rosen P P Rosenrsquos Breast Pathology Lippincott WilliamsampWilkins 2001
Literatuacutera použitaacute v ŠPP OKPC02
1 Čunderliacutekovaacute M Balaacutežovaacute V Vybraneacute kapitoly z histologickej techniky Vydavateľstvo Osveta 1990 s167 ISBN 80-217-0269-9
2 Vacek Z Histologie a histologickaacute technika 1 vyd Institut pro dalšiacute vzdělaacutevaacuteniacute pracovniacuteků ve zdravotnictviacute 1996
3 Susan C Lester Manual of Surgical Pathology 2 edition Elsevier Churchill Livingstone 2006
4 Bancroft JD Gamble M Theory and practice of histological techniques Churchil-Livingstone 6th edition 2008 ISBN978-0-443-10279-0 s725
5 Callis GM Bone In Bancroft JD Gamble M Theory and practice of histological techniques Churchil-Livingstone 6th edition 2008 s333 ndash
363
Literatuacutera použitaacute v ŠPP OKPC03
1 Susan C Lester Manual of Surgical Pathology 2 edition Elsevier Churchill Livingstone 2006
2 Rosai and Ackerman Surgical Pathology ed Juan Rosai 9 vyd Mosby Elsevier inc 2004
3 Leverrsquos Histopathology of the Skin ed David E Elder 9 vyd Lippincott WilliamsampWilkins 2005
4 Vacek Z Histologie a histologickaacute technika 1 vyd Institut pro dalšiacute vzdělaacutevaacuteniacute pracovniacuteků ve zdravotnictviacute 1996
5 Mezinaacuterodniacute klasifikace nemociacute pro onkologii 3 vyd Světovaacute zdravotnickaacute organizace 2000
6 Pathology and Genetics of Tumours of Haematopoietic and Lymphoid Tissues ed Elaine S Jaffe Nancy Lee Harris Harald Stein James W
Vardiman IARCPress 2001
9 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
7 Pathology and Genetics of Tumours of the Breast and Female Genital Organs ed Fattaneh ATavassoli Peter Devilee IARCPress 2003
8 Pathology and Genetics of Tumours of the Digestive System ed Stanley R Hamilton Lauri A Aaltonen IARCPress 2000
9 Pathology and Genetics of Tumours of Soft Tissue and Bone ed Christopher D M
10 Fletcher K Krishnan Unni Fredrik Mertens IARCPress 2002
11 Pathology and Genetics of Tumours of the Urinary System and Male Genital Organs ed John N Eble Guido Sauter Jonathan I Epstein Isabell A
Sesterhenn IARCPress 2004
12 Pathology and Genetics of Tumours of the Nervous System ed Paul Kleihnes Webster K Cavenee IARCPress 2000
13 Blausteinrsquos Pathology of the Female Genital Tract ed Robert J Kurman Springer-Verlag
New York 2002
14 Rosen P P Rosenrsquos Breast Pathology Lippincott WilliamsampWilkins 2001
Literatuacutera použitaacute v ŠPP OKPC04
1 Gomolčaacutek P Zaacuteklady imunohistocheacutemie v patoloacutegii IDVPZ Brno 1997 92 s ISBN 80-7013-239-6
2 Key M et al Immunohistochemical staining methods fourth edition education guide DAKO corporatio Carpinteacuteria California 2006 174 s
3 Lukaacuteš Z Draacuteberovaacute E Feit J Vojtěšek B Imunohistochemickeacute metody v biologii a v bioptickeacute diagnostice Acta facultatis medicae Universitatis
Masarykianae Brunensis Sborniacutek praciacute LF v Brně č 112 LF Masarykovy University Brno 1997 147 s ISBN 80-210-0620-X
4 Taylor CR Cote RJ Immunomicroscopy a diagnostic tool for the surgical pathologist third edition Saunders Elsevier 2006 531 s ISBN
0721601820
5 httpwwwihcworldcom
6 httpdistdakocom
7 Shi S-R Key ME Kalra KL Antigen retrieval in formalinfixed paraffin-embedded tissues an enhancement method for immunohistochemical
staining based on microwave oven heating of tissue sections J Histochem Cytochem 1991 39(6) 741-748
8 Shi S-R Cote RJ Taylor CR Antigen retrieval immunohistochemistry past present and future J Histochem Cytochem 1997 45 (3) 327-343
9 Miller RT Technical immunohistochemistry achieving reliability and reproducibility of immunostains [online] New York Society for Applied
Immunohistochemistry Annual Meeting 2001 [cit 2008-12-12] Dostupneacute na lthttpwwwihcworldcom_booksTechnical-IHCpdfgt
Literatuacutera použitaacute v ŠPP OKPC05
1 WiedGKeebler CM Koos LG Patten SFRosenthal DL Compendium on Diagnostic Cytology
2 Richard M De May The Art and Science of Cytopathology
3 Adam P Taborskyacute L Sobek O Kolbich PCytogy of cerebrospinal fluid
4 Takahashi MColor atlas of cancer cytology
Literatuacutera použitaacute v ŠPP OKPC06
1 WiedGKeebler CM Koos LG Patten SFRosenthal DL Compendium on Diagnostic Cytology
2 Richard M De May The Art and Science of Cytopathology
3 JKobilkovaacute JSirackyacute a kolCytodiagnostika v gynekologii
4 JKobilkovaacuteZLojdaJOndrušABekovaacute Gynekologickaacute cytodiagnostika
5 JKobilkovaacute Zaacuteklady cytopatoloacutegie
10 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Flexibilnyacute rozsah akreditaacutecie
Naacutezov akreditovaneacuteho subjektu Onkologickyacute uacutestav sv Alžbety sro
Heydukova 10 812 50 Bratislava
Uacutestav laboratoacuternej mediciacuteny SZU a OUacuteSA
Oddelenie lekaacuterskej genetiky
Flexibilnyacute rozsah akreditaacutecie je zverejnenyacute na adrese
httpwwwousask_imgDocumentsDocumentyZoznam_akreditovanych_cinnostipdf
Polo
žka Objekt skuacutešky Zavedenaacute metoacuteda
Ostatneacute
špecifikaacutecie Systeacutem
Biologickyacute
materiaacutel
Analyt
Ukazovateľ
Princiacutep
Druh
Typ
Označenie
1 Analyacuteza germinatiacutevnych variantov
11
Ľudskaacute
perifeacuterna krv
-Germinatiacutevne varianty v geacutene
BRCA12
Izolaacutecia DNA
PCR
amplifikaacutecia
Sekvenačnaacute
analyacuteza
ŠPP OLG1
(dolu uved orig
praacutece)
Kvalitatiacutevna skuacuteška
12 -Germinatiacutevne varianty v geacutene RET
Izolaacutecia DNA
PCR
amplifikaacutecia
Sekvenačnaacute
analyacuteza
ŠPP OLG2
(dolu uved orig
praacutece)
13 - - Docirckaz germinatiacutevnych variantov v
geacutene MLH1 a MSH2
Izolaacutecia DNA
PCR
amplifikaacutecia
Sekvenačnaacute
analyacuteza
ŠPP OLG10
(dolu uved orig
praacutece)
14 - - Docirckaz germinatiacutevnych variantov
v geacutene VHL
Izolaacutecia DNA
PCR
amplifikaacutecia
Sekvenačnaacute
analyacuteza
SPP OLG14
(dolu uvedeneacute
origpraacutece)
15
- - Docirckaz germinatiacutevnych variantov
v paneli geacutenov asociovanyacutech
s onkologickyacutemi hereditaacuternymi
syndroacutemami
Izolaacutecia DNA
PCR
amplifikaacutecia
Sekvenačnaacute
analyacuteza
SPP OLG15
(dolu uvedeneacute
origpraacutece)
2 Analyacuteza somatickyacutech variantov
21
Fixovaneacute
natiacutevne tkanivo
- Docirckaz somatickyacutech variantov
v exoacutenoch 2 3 a 4 geacutenu KRAS a
NRAS pri naacutedoroch kolorekta
Izolaacutecia DNA
PCR
amplifikaacutecia
Mini-sekvenačnaacute
analyacuteza
Real-Time PCR
ŠPP OLG5
(dolu uved orig
praacutece)
Kvalitatiacutevna skuacuteška 22
- Docirckaz somatickyacutech variantov
v kodoacutene 600 geacutenu BRAF pri
naacutedoroch štiacutetnej žľazy a maliacutegnom
melanoacuteme
Izolaacutecia DNA
PCR
amplifikaacutecia
Mini-sekvenačnaacute
analyacuteza
Real-Time PCR
ŠPP OLG9
(dolu uved orig
praacutece)
ŠPP OLG5
(dolu uved orig
praacutece)
23
Fixovaneacute
natiacutevne
tkanivocytologi
ckeacute stery
- Docirckaz somatickyacutech variantov
v exoacutenoch 18 19 20 a 21 geacutenu
EGFR pri nemalobunkovom
karcinoacuteme pľuacutec
Izolaacutecia DNA
PCR
amplifikaacutecia
Mini-sekvenačnaacute
analyacuteza
Real-Time PCR
ŠPP OLG11
(dolu uved orig
praacutece)
ŠPP OLG5
(dolu uved orig
praacutece)
11 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Polo
žka Objekt skuacutešky Zavedenaacute metoacuteda
Ostatneacute
špecifikaacutecie Systeacutem
Biologickyacute
materiaacutel
Analyt
Ukazovateľ
Princiacutep
Druh
Typ
Označenie
24 Fixovaneacute
natiacutevne tkanivo
-Docirckaz somatickyacutech variantov
v geacutene BRCA12
Izolaacutecia DNA
PCR
amplifikaacutecia
Sekvenačnaacute
analyacuteza
Mini-skevenačnaacute
analyacuteza
ŠPP OLG16
(dolu uved orig
praacutece)
Kvalitatiacutevna skuacuteška
4 Genotypizaacutecia ľudskyacutech papilomaviacuterusov
41
Bunkovaacute
suzpenzia
fixovaneacute
tkanivo
perifeacuterna krv
-Genotypizaacutecia HPV
Izolaacutecia DNA
PCR
amplifikaacutecia
Real-Time PCR
ŠPP OLG3
(dolu uved orig
praacutece)
Kvalitatiacutevna skuacuteška
5 Docirckaz priacutetomnosti HPV
51 Bunkovaacute
suzpenzia -Docirckaz priacutetomnosti HPV
Izolaacutecia DNA
Real-Time PCR
ŠPP OLG13
(dolu uved orig
praacutece)
Kvalitatiacutevna skuacuteška
6 Docirckaz veľkyacutech geacutenovyacutech prestavieb v geacutenoch asociovanyacutech s onkologickyacutemi hereditaacuternymi syndroacutemami metoacutedou MLPA
61
Ľudskaacute
perifeacuterna krv
Fixovaneacute
natiacutevne tkanivo
- - Docirckaz veľkyacutech geacutenovyacutech
prestavieb v geacutenoch asociovanyacutech s
onkologickyacutemi hereditaacuternymi
syndroacutemami metoacutedou MLPA
Izolaacutecia DNA
PCR
amplifikaacutecia
Fragmentačnaacute
analyacuteza
SPP OLG17
(dolu uvedeneacute
origpraacutece)
Kvalitatiacutevna skuacuteška
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG1
1 Friedman L Ostermeyer E A Szabo CI a kol Confirmation of BRCA1 by analysis of germline mutations linked to breast and ovarian cancer in
ten families Nat Genetics 8 399-404 1994
2 Miki Y Katagiri T Kasumi F a kol Mutation analysis in the BRCA2 gene in primary breast cancer Nat Genetics 2 245-7 1996
3 Wagner T M U Hirtenlehner K Shen P a kol Global sequence diversity of BRCA2 analysis of 71 breast cancer families and 95 control
individuals of worldwilde populatins Hum Mol Genetocs Vol 8 No 3 1999
4 QIAamp DNA Mini Kit and OIAamp DNA Blood Mini Kit Handbook
5 Nanodrop ND 1000 useracutes manual
6 Promega Protocols and applications guide The Source for Discovery PCR cheapter Promega Corporation USA 1996
7 Amersham Pharmacia Biotech DNA Silver Staining Kit instructions
8 BigDye Terminator v 11 Cycle Sequencing Kit Protokol Applied Biosystems
9 Applied Biosystems DNA Sequencing Analysis Software Version 51 for Windows XP and 2000 Platforms User Guide Applied Biosystems
10 Applied Biosystems 31303130xl Genetic Analyzers Getting Started Guide Applied Biosystems
11 Konecny M et al Comprehensive genetic characterization of hereditary breastovarian cancer families from Slovakia Breast Cancer Res Treat
(2011) 126119ndash130
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG2
1 Ceccherini I Hofstra RMW Luo Y a kol DNA polymorphisms and conditions for SSCP analysis of the 20 exons of the RET proto-oncogene
Oncogene 9 3025-3029 1994
2 De Groot et al RET as a dignostic and therapeutic target in sporadic and hereditary endocrine tumors 2006 Endocrine Reviews 27(5) 535-560
3 Martucciello G Lerone M et al Multiple endocrine neoplasias type 2B and RET proto-oncogene Ital J Pediatr 2012 Mar 19389 doi
1011861824-7288-38-9 Review
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG3
1 Weismanovaacute E Weismann P Vizvaacuteryovaacute M a kol New approach to human high-risk papillomavirus (HR-HPV) genotyping Neoplasma 49
217-224 2002
2 Amersham Biosciences GenomicPrep Cells and Tissue DNA Isolation Kit instructions
3 Amersham Pharmacia Biotech QuickPrep Total RNA Extraction Kit instructions
4 Amersham Pharmacia Biotech Ready To Go You-Prime First-Strand Beads instructions
5 Amersham Pharmacia Biotech Ready To Go PCR Beads instructions
6 Amersham Pharmacia Biotech DNA Silver Staining Kit instructions
7 F-HPV typingTM Kit Manual
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG5
1 Van Krieken J H J M Jung A Kirchner T a kol KRAS mutation testing for predicting response to anti-EGFR therapy for colorectal carcinoma
proposal for an European quality assurance program Virchows Arch (2008) 453417-431
2 Lievre A Bachet J Le Corre D a kol KRAS mutation status is predictive of response to cetuximab therapy in colorectal cancer Cancer Res
(2006) 668
3 TheraScreen K-RAS Mutation Manual
4 BigDye Terminator v 11 Cycle Sequencing Kit Protokol Applied Biosystems
5 Applied Biosystems DNA Sequencing Analysis Software Version 51 for Windows XP and 2000 Platforms User Guide Applied Biosystems
6 Applied Biosystems 3500 Genetic Analyzers Getting Started Guide Applied Biosystems
8 SNaPshot Multiplex Kit ndash protocol and manual
12 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG9 1 Nikiforov YE thyroid carcinoma molecular pathways and therapeutic targets Modern pathology 21S37-S43 2008
2 Elisei R Ugolini C Viola D Lupi C et al BRAF V600E mutation and outcome of patients with papillary thyroid carcinoma
A 15-year median follow-up study J Clin endocrine Metab 93(10)3943-3949 2008
3 SNaPshot Multiplex Kit ndash protocol and manual Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG10
1 Brigitte Wolf Silvia Henglmueller at al Spectrum of germ-line MLH1 and MSH2 mutations in Austrian patientswith hereditary nonpolyposis
colorectal cancer The Middle European Journal of Medicine 2005 1177ndash8 269ndash277
2 Elisabeth mangold Constanze Pagenstecher et al Spectrum and frequencies of mutations in MSH2 and MLH1 identified in 1721 german families
suspected of hereditary nonpolyposis colorectal cancer Int J Cancer 2005 116 692-702
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG11
1 Rosell R Moran T Queralt C Porta R Cardenal F Camps C Majem M Lopez-Vivanco G Isla D Provencio M Insa A Massuti
B Gonzalez-Larriba J L Paz-Ares L Bover I Garcia-Campelo R Moreno M A Catot S Rolfo C Reguart N Palmero R Sanchez
JM Bastus R Mayo C Bertran- Alamillo J Molina M A Sanchez J J Taron M (2009) Screening for epidermal growth factor receptor
mutations in lung cancer N Engl J Med 361 958-967
2 Peacuterez-Soler R Chachoua A Hammond L A Rowinsky E K Huberman M Karp M Rigas J Clark G M Santabaacuterbara P Bonomi P
(2004) Determinants of Tumor Response and Survival With Erlotinib in Patients With NonndashSmall-Cell Lung Cancer Journal og Clinical
Oncology 22 16
3 Pines G Koumlstler W JYosef Yarden Department of Biological Regulation The Weizmann Institute of Science Rehovot 76100 Israel (2010)
Oncogenic mutant forms of EGFR lessons in signal transduction and targets for cancer therapy FEBSLett 584 (12) 2699ndash2706
4 ABI PRISM SnaPshot Multiplex Kit ndashProtocol and manual
5 cobasreg EGFR Mutation Test ndash User Manual
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG13
1 cobasreg 4800 HPV Test ndash Dokument č 05990343001-04SK Roche Diagnostics GmbH
2cobasreg 4800 HPV Test ndash Dokument č 05641268001-01 Roche Molecular Systems Inc
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG14
1 Nielsen SM Rhodes L Blanco I a kol 2016 Von Hippel-Lindau Disease Genetics and Role of Genetic Counseling in a Multiple Neoplasia
Syndrome J Clin Oncol 34(18)2172-2181
2 Alberta Health Services 2011 Renal cell carcinoma and genetic testing Clinical Practice Guideline GU-005
3 Chittiboina P Lonser RR 2015 Von Hippel-Lindau disease Handb Clin Neurol132139-156
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG15
1 Hereditary Cancer Solution by Sophia Genetics ndash Users guide using DNA library prep kit by Sophia genetics 48 samples
2 BRCA Hereditary Cancer MASTR Plus kit with drMID for Ilumina NGS systems ndash instructions for use
3 Crawford B Adams S B Sittler et al (2017) Multi-gene panel testing for hereditary cancer predisposition in unsolved high-risk breast and ovarian
cancer patients Breast cancer research and treatment 163(2) 383-390
4 Grissom A A Friend P J (2016) Multigene Panel Testing for Hereditary Cancer Risk Journal of the advanced practitioner in oncology 7(4) 394-
407
5 Lorans M Dow E Macrae FA Winship IM Buchanan DD (2018) Update on Hereditary Colorectal Cancer Improving the Clinical Utility of
Multigene Panel Testing Clin Colorectal Cancer 17(2)e293-e305
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG16
1 Ledermann PARP inhibitors in ovarian cancer Annals of Oncology (2016) 27 i40ndashi44
2 Koczkowska M et al Detection of somatic BRCA12 mutations in ovarian cancer - next-generation sequencing analysis of 100 cases Cancer Med
2016 Jul5(7)1640-6
3 Dougherty BA et al Biological and clinical evidence for somatic mutations in BRCA1 and BRCA2 as predictive markers for olaparib response in
high-grade serous ovarian cancers in the maintenance setting Oncotarget 2017 Jul 48(27)43653-43661
4 Maxwell KN et al BRCA locus-specific loss of heterozygosity in germline BRCA1 and BRCA2 carriers Nat Commun 2017 Aug 228(1)319
5 httpswwwagilentcomcslibrarybrochuresBrochure20Complete20solution20BRCA20MASTR20(Plus)20Dx20v1708pdf
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG17
1 MRC-Holland ndash MLPA General Protocol httpswwwmlpacom
2 Ticha I Kleibl Z Stribrna J a kol Screening for genomic rearragements in a genes in Czech high-risk breastovarian cancer patients high
proportion of population specific alterations in gene Breast Cancer Research and Treatment 2010 124 (2)337-347
3 Sluiter MD van Rensburg EJ Large genomic rearragements of the BRCA1 and BRCA2 genes review of the literature and report of a novel BRCA1
mutation Breast Cancer Research and Treatment 2011 125 325-349
Osoby spocircsobileacute modifikovať a validovať metoacutedy na Oddeleniacute lekaacuterskej genetiky
Meno a priezvisko tituly Spocircsobilosť modifikovať a validovať metoacutedy
ndash čiacuteslo položky v rozsahu akreditaacutecie
Regiacutena Lohajovaacute Behulovaacute RNDr PhD 11 až 61
Katariacutena Zaacutevodnaacute RNDr PhD 11 až 61
Ľudmila Vavrovaacute Ing PhD 11 až 61
Tomaacuteš Slamka Mgr 11 až 61
Lukaacuteš Šebest Mgr PhD 11 až 61
Aster Alemayehu RNDr PhD 11 až 61
13 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Použiteacute skratky
AGLUT ndash aglutinačnaacute reakcia
AOD ndash askorbaacutetoxidaacuteza
BRCA ndash označenie geacutenu asociovaneacuteho s dedičnou formou mamaacuternehoovariaacutelneho karcinoacutemu
CDKN2A ndash označenie geacutenu asociovaneacuteho s dedičnou formou maliacutegneho melanoacutemu
E6E7 - HPV viacuterusoveacute onkogeacuteny asociovaneacute so vznikom a progresiou Ca krčka maternice
FOTO - fotometria
GLD ndash glutamaacutetdehydrogenaacuteza
GPO ndash glycerol-3-fosfaacutet-oxidaacuteza
HPLC ndash High Performance Liquid Chromatography
HPV ndash human papillomavirus (ľudskyacute papilloma viacuterus)
CHOD ndash cholesteroloxidaacuteza
IFCC ndash International Federation for Clinical Chemistry
IMF ndash meranie fluorescencie po značeniacute buniek protilaacutetkami
KOAG ndash Coagulation Point Detection Method
KRAS ndash označenie geacutenu kt somatickeacute mutaacutecie v suacute predikatiacutevnym markerom pri metastazujuacutecom ca hrubeacuteho čreva
LATEX ndash Latex immunoassay method
MLH1 - označenie geacutenu asociovaneacuteho s dedičnou formou kolorektaacutelneho karcinoacutemu
MSH2 - označenie geacutenu asociovaneacuteho s dedičnou formou kolorektaacutelneho karcinoacutemu
NRAS ndash označenie geacutenu kt somatickeacute mutaacutecie v suacute predikatiacutevnym markerom pri metastazujuacutecom ca hrubeacuteho čreva
OHT - Oddelenie hematoloacutegie a transfuzioloacutegie
OID ndash Oddelenie imunodiagnostiky
OKB ndash Oddelenie klinickej biocheacutemie
OKIA - Oddelenie klinickej imunoloacutegie a alergoloacutegie
OKPC - Oddelenie klinickej patoloacutegie a cytoloacutegie
OLG ndash Oddelenie lekaacuterskej genetiky
PAP ndash peroxidaacuteza
PCR ndash polymeraacutezovaacute reťazovaacute reakcia
PHOTO ndash spektrofotometrickaacute metoacuteda
PLP ndash pyridoxalfosfaacutet
POD ndash peroxidaacuteza
RET ndash označenie geacutenu v dedičnej forme medulaacuterneho karcinoacutemu a syndroacutemu mnohopočetnej endokrinnej neoplaacutezie typu 2
RIA - Radio Immunoassay
RT - Real-Time
ŠPP ndash Štandardnyacute pracovnyacute postup
TPO ndash Tyreoidaacutelna peroxidaacuteza
TRACE ndash Time Resolved Amplified Cryptate Emission
5 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Polo
žka Objekt skuacutešky Zavedenaacute metoacuteda
Ostatneacute
špecifikaacutecie Systeacutem
Biologickyacute
materiaacutel
Analyt
Ukazovateľ
Princiacutep
DruhTyp Označenie
8 celaacute krv
v K3EDTA Krvnaacute skupina KS+Rh(D) AGLUT
Galileo ECHO ndash ManuaacutelAplikačneacute listy
(ŠPP 22HTO)
9 plazma
v K3EDTA
Skriacutening anti-
Ery protilaacutetok
Skriacutening NAT AGLUT
Galileo ECHO ndash ManuaacutelAplikačneacute listy
(ŠPP 23HTO)
NAT-P1 AGLUT
NAT-P2 AGLUT
NAT-P3 AGLUT
10
plazma
v K3EDTA
a erytrocyty
z transfuacutezneh
o priacutepravku
Kriacutežny pokus AGLUT Galileo ECHO ndash ManuaacutelAplikačneacute listy
(ŠPP 24HTO)
11 celaacute krv
v K3EDTA
Stanovenie CD
znakov
CD3
Prietokovaacute
cytometria
Becton Dickinson FACS Canto - Manuaacutel
(ŠPP 30HTO)
IMF
CD2
CD4
CD5
CD8
CD56
CD7
CD45
CD3CD8
CD3CD4
CD10
CD19
CD20
CD23
Kappa
Lambda
KappaCD19
LambdaCD19
CD38
CD22
CD11c
CD33
CD13
CD34
CD14
HLA DR
CD16
CD15
Oddelenie klinickej imunoloacutegie a alergoloacutegie ndashOKIA Laboratoacuterium s fixnyacutem rozsahom
Polo
žka Objekt skuacutešky Zavedenaacute metoacuteda
Ostatneacute
špecifikaacutecie Systeacutem
Biologickyacute
materiaacutel
Ukazovateľ
Analyt
Parameter
Princiacutep
Druh
Typ
Označenie
1 krv Stanovenie CD
znakov
CD3 (T Lymfocyty)
CD4 (Pomocneacute T Lymfocyty)
CD8 (Cytotoxickeacute T
Lymfocyty)
CD19 (B Lymfocyty)
CD3-CD16+56 (NK bunky)
Prietokovaacute
cytometria
Becton Dickinson FACS
Canto
(ŠPP OKIA11-15)
2 krv
Stanovenie
fagocytovej
aktivity
FAGO Vyšetrenie
fagocytaacuternej aktivity
granulocytov
Prietokovaacute
cytometria
FagoFlowEx Kit Exbio
(ŠPP OKIA21)
3 seacuterum Stanovenie
celkoveacuteho IgE
IGE - Stanovenie celkoveacuteho
IgE
FEIA
(Fluorescenčnaacute
enzyacutemovaacute
imunoanalyacuteza)
ImmunoCAPreg Total IgE
(ŠPP OKIA32)
6 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Polo
žka Objekt skuacutešky Zavedenaacute metoacuteda
Ostatneacute
špecifikaacutecie Systeacutem
Biologickyacute
materiaacutel
Ukazovateľ
Analyt
Parameter
Princiacutep
Druh
Typ
Označenie
4 seacuterum Stanovenie
špecifickyacutech IgE
SIGE - Stanovenie
špecifickyacutech IgE
Enzyacutemovaacute
imunoanalyacuteza
HY-TEC Specific IgE
HYCOR
(ŠPP OKIA41)
SIGE - Stanovenie
špecifickyacutech IgE
FEIA
(Fluorescenčnaacute
enzyacutemovaacute
imunoanalyacuteza)
ImmunoCAPregSpecific
IgE Phadia
(ŠPP OKIA4 2 )
5 seacuterum
Stanovenie parametrov humoraacutelnej odpovede
Enzyacutemovaacute
imunoanalyacuteza
DSX
potravinoveacute
intolerancie
GLIAA Stanovenie protilaacutetok
triedy IgA proti gliadiacutenu
Anti-Gliadin (GAF-3X)
ELISA-(IgA) Euroimmun
(ŠPP OKIA513)
GLIAG Stanovenie protilaacutetok
triedy IgG proti gliadiacutenu
Anti-Gliadin (GAF-3X)
ELISA-(IgG) Euroimmun
(ŠPP OKIA514)
TTG A Stanovenie protilaacutetok
triedy IgA proti tkanivovej
transglutaminaacuteze
Protilaacutetky proti tkaňoveacute
transglutamnaacuteze ELISA
(IgA) Euroimmun
(ŠPP OKIA515)
ASCA Stanovenie protilaacutetok
triedy IgA proti
Saccharomyces cerevisiae
EIA Anti-ASCA IgA
AIDA
(ŠPP anti-ASCA IgA
516)
ASCAG Stanovenie
protilaacutetok triedy IgG proti
Saccharomyces cerevisiae
EIA Anti-ASCA IgG
AIDA
(ŠPP anti-ASCA IgG
517)
autoprotilaacutetky
RFC Stanovenie protilaacutetok
triedy IgA IgM IgM proti
reumatoidneacutemu faktoru
Rf-Check AIDA
(ŠPP OKIA522)
CCP Stanovenie protilaacutetok
proti cyklickeacutemu
citruliacutenoveacutemu proteiacutenu
RACP Detect AIDA
(ŠPP OKIA523)
6 seacuterum
plazma
Stanovenie
zložiek
komplementu
C1F Vyšetrenie funkčnej
aktivity C1 inhibiacutetora
Enzyacutemovaacute
imunoanalyacuteza
A003-MicroVue C1-
Inhibitor Plus EIA Kit
Quidel (ŠPP OKIA61)
Oddelenie klinickej patoloacutegie a cytoloacutegie -OKPC Uacutestav patoloacutegie SZU a OUacuteSA
Polo
žka Objekt skuacutešky Zavedenaacute metoacuteda
Ostatneacute
špecifikaacutecie Systeacutem
Biologickyacute
materiaacutel
Analyt
Ukazovateľ
Princiacutep
Druh
Typ
Označenie
Oddelenie klinickej patoloacutegie a cytoloacutegie -OKPC
1 tkanivo histopatologickeacute
zmeny
Histologickeacute
vyšetrenie tkaniva
(biopsia)
ŠPP OKPC01
ŠPP OKPC02
ŠPP OKPC03
ŠPP OKPC04
(Literatuacutera viď
priacuteloha č 4)
histoloacutegia peroperačneacute biopsie spracovanie
tvrdyacutech tkaniacutev histocheacutemia 1
imunohistocheacutemia 2 mikroskopickeacute hodnotenie
2
moč
vyacutepotok
otlačok
ascitickaacute
tekutina naacuteter
PAB (punkčnaacute
aspiračnaacute
biopsia)
cytopatologickeacute
zmeny
cytologickeacute
vyšetrenie
negynekolo-gickeacute
ŠPP OKPC05
(Literatuacutera viď
priacuteloha č 4)
farbenie naacuteterov polychromatickou metoacutedou
podľa Papanicolaua13
mikroskopickaacute diagnostika
7 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Polo
žka Objekt skuacutešky Zavedenaacute metoacuteda
Ostatneacute
špecifikaacutecie Systeacutem
Biologickyacute
materiaacutel
Analyt
Ukazovateľ
Princiacutep
Druh
Typ
Označenie
3
gynekologickyacute
ster materiaacutel
odobratyacute na
Liquid based
cytology (LBC)
cytopatologickeacute
zmeny
cytologickeacute
vyšetrenie
gynekologickeacute
Liquid based
cytology (LBC)
ŠPP OKPC06
(Literatuacutera viď
priacuteloha č 4)
farbenie naacuteterov polychromatickou metoacutedou
podľa Papanicolaua3 imunocytocheacutemia
mikroskopickaacute diagnostika
systeacutem diagnostickeacuteho hodnotenia gynekologickej
cytoloacutegie Bethesda 2001
1 Priacuteloha 1 Zoznam histochemickyacutech farbiacich a impregnačnyacutech metoacuted na OKPC UacuteP
1 Farbenie hematoxyliacutenom-eoziacutenom
2 Docirckaz polysacharidov PAS reakciou podľa Mc Manusa
3 Farbenie HP podľa Giemsu
4 Impregnaacutecia podľa Gomoriho
5 Farbenie kolageacutenvyacutech vlaacutekien podľa van Giesona
6 Docirckaz železa Perlsovou reakciou
7 Amyloid kongočerveňou podľa Puchtlerovej
8 Impregnačnaacute metoacuteda podľa Grimeliusa
9 Mallory - farbenie na fibriacuten
10 Kysleacute mukopolysacharidy - Alciaacutenovaacute modraacute
11 Farbenie na docirckaz Melaniacutenu podľa Lignaca
12 Mucikarmiacuten podľa Mayera
13 Docirckaz Mycbacterium tuberculosis podľa Ziehl-Neelsena
14 Bakteacuterie podľa Gramma
15 Docirckaz glykogeacutenu metoacutedou PAS-diastaacuteza
16 Zelenyacute Trichroacutem podľa Massona
17 Docirckaz lipidov podľa Lillieho
18 Rezorciacuten-fuchsiacuten podľa Weigerta na elastickeacute vlaacutekna
19 Docirckaz plesniacute ndash impregnačnaacute metoacuteda podľa Gomoriho
20 Kombinovanaacute metoacuteda PAS ndash Alciaacutenovaacute modraacute
2 Priacuteloha 2 Zoznam všetkyacutech antigeacutenov vyšetrovanyacutech imunohistochemickou metoacutedou na OKPC UacuteP
Protilaacutetka proti antigeacutenu Skratka Vyacuterobca
Aktiacuten (smooth muscle) ASM Dako
Alfa-1-fetoproteiacuten AFP Dako
Androgeacutenovyacute receptor AR Novocastra
Bcl-2 BCL2 Dako
Βetacatenin BCAT Dako
Caldesmon CDES Dako
Calretinin CRT Dako
CD10 CD10 Novocastra
CD20cy CD20 L26 Dako
CD30 CD30 Dako
CD31 CD31 Dako
CD34 Class II CD34 Dako
CD45 CD45 LCA Dako
CD45RO CD45RO UCHL1 Dako
CD56 CD56 Dako
CD68 CD68 Novocastra
CD99 CD99 Dako
CD117 CD117 Dako
CDX2 CDX2 Dako
Cytokeratiacuten 56 CK56 Dako
Cytokeratiacuten 7 CK7 Novocastra
Cytokeratiacuten 18 CK18 Dako
Cytokeratiacuten 19 CK19 Dako
Cytokeratiacuten 20 CK20 Novocastra
Cytokeratiacuten AE1AE3 AE13 Dako
Cytokeratiacuten HMW CKHMW Dako
Dezmiacuten DEZ Novocastra
EGFR EGFR Dako
E-kadheriacuten CAD Dako
Epitelovyacute membraacutenovyacute antigeacuten EMA Dako
Estrogeacutenovyacute receptor ER Novocastra
Gastrin GAST Dako
Glukagon GLUK Dako
Gross cystic disease fluid protein-15 GCDF Dako
Ľudskyacute choriogonadotropiacuten HCG Dako
Helicobacter pylori HP Dako
Hepatocyte HEP Dako
HER2 HER2 Dako
Chromograniacuten A CHROM Dako
8 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Inhibiacuten INH Novocastra
Inzuliacuten INZ Dako
Kalcitoniacuten KALC Dako
Kappa light chains IgK Dako
Karbonickaacute anhydraacuteza IX CAIX BioScience
Karcinoembryonaacutelny antigeacuten (monoklonaacutelna) CEA Dako
Ki-67 Ki-67 Novocastra
Lambda light chains IgL Dako
Mammaglobin MAM Dako
Melan A MELAN Dako
Melanozoacutem HMB45 Dako
Mismatch repair protein MLH1 MLH1 Novocastra
Mismatch repair protein MSH2 MSH2 Novocastra
Mismatch repair protein MSH6 MSH6 Dako
Mismatch repair protein PMS2 PMS2 Dako
Myogenin MG Dako
Enolaacuteza špecifickaacute pre neuroacuteny NSE Dako
OCT34 OCT34 Novocastra
Placentaacuterna alkalickaacute fosfataacuteza PLAP Novocastra
p16 p16 Santa Cruz Biotechnology
p53 p53 Novocastra
p63 p63 Dako
-metyl-CoA Racemaacuteza AMACR Dako
Progesteroacutenovyacute receptor PR Novocastra
Prostatickyacute špecifickyacute antigeacuten PSA Dako
Serotonin SRT Dako
Somatostatin SOM Dako
S-100 S-100 Dako
Synaptofyziacuten SYN Novocastra
Tyreoglobuliacuten THG Dako
Tyreoidnyacute transkripčnyacute faktor -1 TTF-1 Dako
Vimentiacuten VIM Dako
WT1 WT1 Dako
3 Priacuteloha 3 Zoznam cytochemickyacutech farbeniacute použiacutevanyacutech na UacuteP
1 Farbenie hematoxyliacutenom-eoziacutenom
2 Farbenie podľa Giemsa ndash Romanowski
3 Farbenie podľa Papanicolaoua ndash polychroacutem EA-50 (PAP)
4 Imunocytochemickeacute vyšetrenie antigeacutenu p16 a Ki67
4 Priacuteloha 4 Zoznam použitej literatuacutery
Literatuacutera použitaacute v ŠPP OKPC01
1 Rosai and Ackerman Surgical Pathology ed Juan Rosai 9 vyd Mosby Elsevier inc 2004
2 Leverrsquos Histopathology of the Skin ed David E Elder 9 vyd Lippincott WilliamsampWilkins 2005
3 Vacek Z Histologie a histologickaacute technika 1 vyd Institut pro dalšiacute vzdělaacutevaacuteniacute pracovniacuteků ve zdravotnictviacute 1996
4 Mezinaacuterodniacute klasifikace nemociacute pro onkologii 3 vyd Světovaacute zdravotnickaacute organizace 2000
5 Pathology and Genetics of Tumours of Haematopoietic and Lymphoid Tissues ed Elaine S Jaffe Nancy Lee Harris Harald Stein James W
Vardiman IARCPress 2001
6 Pathology and Genetics of Tumours of the Breast and Female Genital Organs ed Fattaneh A Tavassoli Peter Devilee IARCPress 2003
7 Pathology and Genetics of Tumours of the Digestive System ed Stanley R Hamilton Lauri A Aaltonen IARCPress 2000
8 Pathology and Genetics of Tumours of Soft Tissue and Bone ed Christopher D M Fletcher K Krishnan Unni Fredrik Mertens IARCPress 2002
9 Pathology and Genetics of Tumours of the Urinary System and Male Genital Organs ed John N Eble Guido Sauter Jonathan I Epstein Isabell A
Sesterhenn IARCPress 2004
10 Pathology and Genetics of Tumours of the Nervous System ed Paul Kleihnes Webster K Cavenee IARCPress 2000
11 Blausteinrsquos Pathology of the Female Genital Tract ed Robert J Kurman Springer-Verlag New York 2002
12 Rosen P P Rosenrsquos Breast Pathology Lippincott WilliamsampWilkins 2001
Literatuacutera použitaacute v ŠPP OKPC02
1 Čunderliacutekovaacute M Balaacutežovaacute V Vybraneacute kapitoly z histologickej techniky Vydavateľstvo Osveta 1990 s167 ISBN 80-217-0269-9
2 Vacek Z Histologie a histologickaacute technika 1 vyd Institut pro dalšiacute vzdělaacutevaacuteniacute pracovniacuteků ve zdravotnictviacute 1996
3 Susan C Lester Manual of Surgical Pathology 2 edition Elsevier Churchill Livingstone 2006
4 Bancroft JD Gamble M Theory and practice of histological techniques Churchil-Livingstone 6th edition 2008 ISBN978-0-443-10279-0 s725
5 Callis GM Bone In Bancroft JD Gamble M Theory and practice of histological techniques Churchil-Livingstone 6th edition 2008 s333 ndash
363
Literatuacutera použitaacute v ŠPP OKPC03
1 Susan C Lester Manual of Surgical Pathology 2 edition Elsevier Churchill Livingstone 2006
2 Rosai and Ackerman Surgical Pathology ed Juan Rosai 9 vyd Mosby Elsevier inc 2004
3 Leverrsquos Histopathology of the Skin ed David E Elder 9 vyd Lippincott WilliamsampWilkins 2005
4 Vacek Z Histologie a histologickaacute technika 1 vyd Institut pro dalšiacute vzdělaacutevaacuteniacute pracovniacuteků ve zdravotnictviacute 1996
5 Mezinaacuterodniacute klasifikace nemociacute pro onkologii 3 vyd Světovaacute zdravotnickaacute organizace 2000
6 Pathology and Genetics of Tumours of Haematopoietic and Lymphoid Tissues ed Elaine S Jaffe Nancy Lee Harris Harald Stein James W
Vardiman IARCPress 2001
9 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
7 Pathology and Genetics of Tumours of the Breast and Female Genital Organs ed Fattaneh ATavassoli Peter Devilee IARCPress 2003
8 Pathology and Genetics of Tumours of the Digestive System ed Stanley R Hamilton Lauri A Aaltonen IARCPress 2000
9 Pathology and Genetics of Tumours of Soft Tissue and Bone ed Christopher D M
10 Fletcher K Krishnan Unni Fredrik Mertens IARCPress 2002
11 Pathology and Genetics of Tumours of the Urinary System and Male Genital Organs ed John N Eble Guido Sauter Jonathan I Epstein Isabell A
Sesterhenn IARCPress 2004
12 Pathology and Genetics of Tumours of the Nervous System ed Paul Kleihnes Webster K Cavenee IARCPress 2000
13 Blausteinrsquos Pathology of the Female Genital Tract ed Robert J Kurman Springer-Verlag
New York 2002
14 Rosen P P Rosenrsquos Breast Pathology Lippincott WilliamsampWilkins 2001
Literatuacutera použitaacute v ŠPP OKPC04
1 Gomolčaacutek P Zaacuteklady imunohistocheacutemie v patoloacutegii IDVPZ Brno 1997 92 s ISBN 80-7013-239-6
2 Key M et al Immunohistochemical staining methods fourth edition education guide DAKO corporatio Carpinteacuteria California 2006 174 s
3 Lukaacuteš Z Draacuteberovaacute E Feit J Vojtěšek B Imunohistochemickeacute metody v biologii a v bioptickeacute diagnostice Acta facultatis medicae Universitatis
Masarykianae Brunensis Sborniacutek praciacute LF v Brně č 112 LF Masarykovy University Brno 1997 147 s ISBN 80-210-0620-X
4 Taylor CR Cote RJ Immunomicroscopy a diagnostic tool for the surgical pathologist third edition Saunders Elsevier 2006 531 s ISBN
0721601820
5 httpwwwihcworldcom
6 httpdistdakocom
7 Shi S-R Key ME Kalra KL Antigen retrieval in formalinfixed paraffin-embedded tissues an enhancement method for immunohistochemical
staining based on microwave oven heating of tissue sections J Histochem Cytochem 1991 39(6) 741-748
8 Shi S-R Cote RJ Taylor CR Antigen retrieval immunohistochemistry past present and future J Histochem Cytochem 1997 45 (3) 327-343
9 Miller RT Technical immunohistochemistry achieving reliability and reproducibility of immunostains [online] New York Society for Applied
Immunohistochemistry Annual Meeting 2001 [cit 2008-12-12] Dostupneacute na lthttpwwwihcworldcom_booksTechnical-IHCpdfgt
Literatuacutera použitaacute v ŠPP OKPC05
1 WiedGKeebler CM Koos LG Patten SFRosenthal DL Compendium on Diagnostic Cytology
2 Richard M De May The Art and Science of Cytopathology
3 Adam P Taborskyacute L Sobek O Kolbich PCytogy of cerebrospinal fluid
4 Takahashi MColor atlas of cancer cytology
Literatuacutera použitaacute v ŠPP OKPC06
1 WiedGKeebler CM Koos LG Patten SFRosenthal DL Compendium on Diagnostic Cytology
2 Richard M De May The Art and Science of Cytopathology
3 JKobilkovaacute JSirackyacute a kolCytodiagnostika v gynekologii
4 JKobilkovaacuteZLojdaJOndrušABekovaacute Gynekologickaacute cytodiagnostika
5 JKobilkovaacute Zaacuteklady cytopatoloacutegie
10 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Flexibilnyacute rozsah akreditaacutecie
Naacutezov akreditovaneacuteho subjektu Onkologickyacute uacutestav sv Alžbety sro
Heydukova 10 812 50 Bratislava
Uacutestav laboratoacuternej mediciacuteny SZU a OUacuteSA
Oddelenie lekaacuterskej genetiky
Flexibilnyacute rozsah akreditaacutecie je zverejnenyacute na adrese
httpwwwousask_imgDocumentsDocumentyZoznam_akreditovanych_cinnostipdf
Polo
žka Objekt skuacutešky Zavedenaacute metoacuteda
Ostatneacute
špecifikaacutecie Systeacutem
Biologickyacute
materiaacutel
Analyt
Ukazovateľ
Princiacutep
Druh
Typ
Označenie
1 Analyacuteza germinatiacutevnych variantov
11
Ľudskaacute
perifeacuterna krv
-Germinatiacutevne varianty v geacutene
BRCA12
Izolaacutecia DNA
PCR
amplifikaacutecia
Sekvenačnaacute
analyacuteza
ŠPP OLG1
(dolu uved orig
praacutece)
Kvalitatiacutevna skuacuteška
12 -Germinatiacutevne varianty v geacutene RET
Izolaacutecia DNA
PCR
amplifikaacutecia
Sekvenačnaacute
analyacuteza
ŠPP OLG2
(dolu uved orig
praacutece)
13 - - Docirckaz germinatiacutevnych variantov v
geacutene MLH1 a MSH2
Izolaacutecia DNA
PCR
amplifikaacutecia
Sekvenačnaacute
analyacuteza
ŠPP OLG10
(dolu uved orig
praacutece)
14 - - Docirckaz germinatiacutevnych variantov
v geacutene VHL
Izolaacutecia DNA
PCR
amplifikaacutecia
Sekvenačnaacute
analyacuteza
SPP OLG14
(dolu uvedeneacute
origpraacutece)
15
- - Docirckaz germinatiacutevnych variantov
v paneli geacutenov asociovanyacutech
s onkologickyacutemi hereditaacuternymi
syndroacutemami
Izolaacutecia DNA
PCR
amplifikaacutecia
Sekvenačnaacute
analyacuteza
SPP OLG15
(dolu uvedeneacute
origpraacutece)
2 Analyacuteza somatickyacutech variantov
21
Fixovaneacute
natiacutevne tkanivo
- Docirckaz somatickyacutech variantov
v exoacutenoch 2 3 a 4 geacutenu KRAS a
NRAS pri naacutedoroch kolorekta
Izolaacutecia DNA
PCR
amplifikaacutecia
Mini-sekvenačnaacute
analyacuteza
Real-Time PCR
ŠPP OLG5
(dolu uved orig
praacutece)
Kvalitatiacutevna skuacuteška 22
- Docirckaz somatickyacutech variantov
v kodoacutene 600 geacutenu BRAF pri
naacutedoroch štiacutetnej žľazy a maliacutegnom
melanoacuteme
Izolaacutecia DNA
PCR
amplifikaacutecia
Mini-sekvenačnaacute
analyacuteza
Real-Time PCR
ŠPP OLG9
(dolu uved orig
praacutece)
ŠPP OLG5
(dolu uved orig
praacutece)
23
Fixovaneacute
natiacutevne
tkanivocytologi
ckeacute stery
- Docirckaz somatickyacutech variantov
v exoacutenoch 18 19 20 a 21 geacutenu
EGFR pri nemalobunkovom
karcinoacuteme pľuacutec
Izolaacutecia DNA
PCR
amplifikaacutecia
Mini-sekvenačnaacute
analyacuteza
Real-Time PCR
ŠPP OLG11
(dolu uved orig
praacutece)
ŠPP OLG5
(dolu uved orig
praacutece)
11 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Polo
žka Objekt skuacutešky Zavedenaacute metoacuteda
Ostatneacute
špecifikaacutecie Systeacutem
Biologickyacute
materiaacutel
Analyt
Ukazovateľ
Princiacutep
Druh
Typ
Označenie
24 Fixovaneacute
natiacutevne tkanivo
-Docirckaz somatickyacutech variantov
v geacutene BRCA12
Izolaacutecia DNA
PCR
amplifikaacutecia
Sekvenačnaacute
analyacuteza
Mini-skevenačnaacute
analyacuteza
ŠPP OLG16
(dolu uved orig
praacutece)
Kvalitatiacutevna skuacuteška
4 Genotypizaacutecia ľudskyacutech papilomaviacuterusov
41
Bunkovaacute
suzpenzia
fixovaneacute
tkanivo
perifeacuterna krv
-Genotypizaacutecia HPV
Izolaacutecia DNA
PCR
amplifikaacutecia
Real-Time PCR
ŠPP OLG3
(dolu uved orig
praacutece)
Kvalitatiacutevna skuacuteška
5 Docirckaz priacutetomnosti HPV
51 Bunkovaacute
suzpenzia -Docirckaz priacutetomnosti HPV
Izolaacutecia DNA
Real-Time PCR
ŠPP OLG13
(dolu uved orig
praacutece)
Kvalitatiacutevna skuacuteška
6 Docirckaz veľkyacutech geacutenovyacutech prestavieb v geacutenoch asociovanyacutech s onkologickyacutemi hereditaacuternymi syndroacutemami metoacutedou MLPA
61
Ľudskaacute
perifeacuterna krv
Fixovaneacute
natiacutevne tkanivo
- - Docirckaz veľkyacutech geacutenovyacutech
prestavieb v geacutenoch asociovanyacutech s
onkologickyacutemi hereditaacuternymi
syndroacutemami metoacutedou MLPA
Izolaacutecia DNA
PCR
amplifikaacutecia
Fragmentačnaacute
analyacuteza
SPP OLG17
(dolu uvedeneacute
origpraacutece)
Kvalitatiacutevna skuacuteška
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG1
1 Friedman L Ostermeyer E A Szabo CI a kol Confirmation of BRCA1 by analysis of germline mutations linked to breast and ovarian cancer in
ten families Nat Genetics 8 399-404 1994
2 Miki Y Katagiri T Kasumi F a kol Mutation analysis in the BRCA2 gene in primary breast cancer Nat Genetics 2 245-7 1996
3 Wagner T M U Hirtenlehner K Shen P a kol Global sequence diversity of BRCA2 analysis of 71 breast cancer families and 95 control
individuals of worldwilde populatins Hum Mol Genetocs Vol 8 No 3 1999
4 QIAamp DNA Mini Kit and OIAamp DNA Blood Mini Kit Handbook
5 Nanodrop ND 1000 useracutes manual
6 Promega Protocols and applications guide The Source for Discovery PCR cheapter Promega Corporation USA 1996
7 Amersham Pharmacia Biotech DNA Silver Staining Kit instructions
8 BigDye Terminator v 11 Cycle Sequencing Kit Protokol Applied Biosystems
9 Applied Biosystems DNA Sequencing Analysis Software Version 51 for Windows XP and 2000 Platforms User Guide Applied Biosystems
10 Applied Biosystems 31303130xl Genetic Analyzers Getting Started Guide Applied Biosystems
11 Konecny M et al Comprehensive genetic characterization of hereditary breastovarian cancer families from Slovakia Breast Cancer Res Treat
(2011) 126119ndash130
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG2
1 Ceccherini I Hofstra RMW Luo Y a kol DNA polymorphisms and conditions for SSCP analysis of the 20 exons of the RET proto-oncogene
Oncogene 9 3025-3029 1994
2 De Groot et al RET as a dignostic and therapeutic target in sporadic and hereditary endocrine tumors 2006 Endocrine Reviews 27(5) 535-560
3 Martucciello G Lerone M et al Multiple endocrine neoplasias type 2B and RET proto-oncogene Ital J Pediatr 2012 Mar 19389 doi
1011861824-7288-38-9 Review
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG3
1 Weismanovaacute E Weismann P Vizvaacuteryovaacute M a kol New approach to human high-risk papillomavirus (HR-HPV) genotyping Neoplasma 49
217-224 2002
2 Amersham Biosciences GenomicPrep Cells and Tissue DNA Isolation Kit instructions
3 Amersham Pharmacia Biotech QuickPrep Total RNA Extraction Kit instructions
4 Amersham Pharmacia Biotech Ready To Go You-Prime First-Strand Beads instructions
5 Amersham Pharmacia Biotech Ready To Go PCR Beads instructions
6 Amersham Pharmacia Biotech DNA Silver Staining Kit instructions
7 F-HPV typingTM Kit Manual
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG5
1 Van Krieken J H J M Jung A Kirchner T a kol KRAS mutation testing for predicting response to anti-EGFR therapy for colorectal carcinoma
proposal for an European quality assurance program Virchows Arch (2008) 453417-431
2 Lievre A Bachet J Le Corre D a kol KRAS mutation status is predictive of response to cetuximab therapy in colorectal cancer Cancer Res
(2006) 668
3 TheraScreen K-RAS Mutation Manual
4 BigDye Terminator v 11 Cycle Sequencing Kit Protokol Applied Biosystems
5 Applied Biosystems DNA Sequencing Analysis Software Version 51 for Windows XP and 2000 Platforms User Guide Applied Biosystems
6 Applied Biosystems 3500 Genetic Analyzers Getting Started Guide Applied Biosystems
8 SNaPshot Multiplex Kit ndash protocol and manual
12 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG9 1 Nikiforov YE thyroid carcinoma molecular pathways and therapeutic targets Modern pathology 21S37-S43 2008
2 Elisei R Ugolini C Viola D Lupi C et al BRAF V600E mutation and outcome of patients with papillary thyroid carcinoma
A 15-year median follow-up study J Clin endocrine Metab 93(10)3943-3949 2008
3 SNaPshot Multiplex Kit ndash protocol and manual Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG10
1 Brigitte Wolf Silvia Henglmueller at al Spectrum of germ-line MLH1 and MSH2 mutations in Austrian patientswith hereditary nonpolyposis
colorectal cancer The Middle European Journal of Medicine 2005 1177ndash8 269ndash277
2 Elisabeth mangold Constanze Pagenstecher et al Spectrum and frequencies of mutations in MSH2 and MLH1 identified in 1721 german families
suspected of hereditary nonpolyposis colorectal cancer Int J Cancer 2005 116 692-702
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG11
1 Rosell R Moran T Queralt C Porta R Cardenal F Camps C Majem M Lopez-Vivanco G Isla D Provencio M Insa A Massuti
B Gonzalez-Larriba J L Paz-Ares L Bover I Garcia-Campelo R Moreno M A Catot S Rolfo C Reguart N Palmero R Sanchez
JM Bastus R Mayo C Bertran- Alamillo J Molina M A Sanchez J J Taron M (2009) Screening for epidermal growth factor receptor
mutations in lung cancer N Engl J Med 361 958-967
2 Peacuterez-Soler R Chachoua A Hammond L A Rowinsky E K Huberman M Karp M Rigas J Clark G M Santabaacuterbara P Bonomi P
(2004) Determinants of Tumor Response and Survival With Erlotinib in Patients With NonndashSmall-Cell Lung Cancer Journal og Clinical
Oncology 22 16
3 Pines G Koumlstler W JYosef Yarden Department of Biological Regulation The Weizmann Institute of Science Rehovot 76100 Israel (2010)
Oncogenic mutant forms of EGFR lessons in signal transduction and targets for cancer therapy FEBSLett 584 (12) 2699ndash2706
4 ABI PRISM SnaPshot Multiplex Kit ndashProtocol and manual
5 cobasreg EGFR Mutation Test ndash User Manual
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG13
1 cobasreg 4800 HPV Test ndash Dokument č 05990343001-04SK Roche Diagnostics GmbH
2cobasreg 4800 HPV Test ndash Dokument č 05641268001-01 Roche Molecular Systems Inc
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG14
1 Nielsen SM Rhodes L Blanco I a kol 2016 Von Hippel-Lindau Disease Genetics and Role of Genetic Counseling in a Multiple Neoplasia
Syndrome J Clin Oncol 34(18)2172-2181
2 Alberta Health Services 2011 Renal cell carcinoma and genetic testing Clinical Practice Guideline GU-005
3 Chittiboina P Lonser RR 2015 Von Hippel-Lindau disease Handb Clin Neurol132139-156
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG15
1 Hereditary Cancer Solution by Sophia Genetics ndash Users guide using DNA library prep kit by Sophia genetics 48 samples
2 BRCA Hereditary Cancer MASTR Plus kit with drMID for Ilumina NGS systems ndash instructions for use
3 Crawford B Adams S B Sittler et al (2017) Multi-gene panel testing for hereditary cancer predisposition in unsolved high-risk breast and ovarian
cancer patients Breast cancer research and treatment 163(2) 383-390
4 Grissom A A Friend P J (2016) Multigene Panel Testing for Hereditary Cancer Risk Journal of the advanced practitioner in oncology 7(4) 394-
407
5 Lorans M Dow E Macrae FA Winship IM Buchanan DD (2018) Update on Hereditary Colorectal Cancer Improving the Clinical Utility of
Multigene Panel Testing Clin Colorectal Cancer 17(2)e293-e305
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG16
1 Ledermann PARP inhibitors in ovarian cancer Annals of Oncology (2016) 27 i40ndashi44
2 Koczkowska M et al Detection of somatic BRCA12 mutations in ovarian cancer - next-generation sequencing analysis of 100 cases Cancer Med
2016 Jul5(7)1640-6
3 Dougherty BA et al Biological and clinical evidence for somatic mutations in BRCA1 and BRCA2 as predictive markers for olaparib response in
high-grade serous ovarian cancers in the maintenance setting Oncotarget 2017 Jul 48(27)43653-43661
4 Maxwell KN et al BRCA locus-specific loss of heterozygosity in germline BRCA1 and BRCA2 carriers Nat Commun 2017 Aug 228(1)319
5 httpswwwagilentcomcslibrarybrochuresBrochure20Complete20solution20BRCA20MASTR20(Plus)20Dx20v1708pdf
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG17
1 MRC-Holland ndash MLPA General Protocol httpswwwmlpacom
2 Ticha I Kleibl Z Stribrna J a kol Screening for genomic rearragements in a genes in Czech high-risk breastovarian cancer patients high
proportion of population specific alterations in gene Breast Cancer Research and Treatment 2010 124 (2)337-347
3 Sluiter MD van Rensburg EJ Large genomic rearragements of the BRCA1 and BRCA2 genes review of the literature and report of a novel BRCA1
mutation Breast Cancer Research and Treatment 2011 125 325-349
Osoby spocircsobileacute modifikovať a validovať metoacutedy na Oddeleniacute lekaacuterskej genetiky
Meno a priezvisko tituly Spocircsobilosť modifikovať a validovať metoacutedy
ndash čiacuteslo položky v rozsahu akreditaacutecie
Regiacutena Lohajovaacute Behulovaacute RNDr PhD 11 až 61
Katariacutena Zaacutevodnaacute RNDr PhD 11 až 61
Ľudmila Vavrovaacute Ing PhD 11 až 61
Tomaacuteš Slamka Mgr 11 až 61
Lukaacuteš Šebest Mgr PhD 11 až 61
Aster Alemayehu RNDr PhD 11 až 61
13 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Použiteacute skratky
AGLUT ndash aglutinačnaacute reakcia
AOD ndash askorbaacutetoxidaacuteza
BRCA ndash označenie geacutenu asociovaneacuteho s dedičnou formou mamaacuternehoovariaacutelneho karcinoacutemu
CDKN2A ndash označenie geacutenu asociovaneacuteho s dedičnou formou maliacutegneho melanoacutemu
E6E7 - HPV viacuterusoveacute onkogeacuteny asociovaneacute so vznikom a progresiou Ca krčka maternice
FOTO - fotometria
GLD ndash glutamaacutetdehydrogenaacuteza
GPO ndash glycerol-3-fosfaacutet-oxidaacuteza
HPLC ndash High Performance Liquid Chromatography
HPV ndash human papillomavirus (ľudskyacute papilloma viacuterus)
CHOD ndash cholesteroloxidaacuteza
IFCC ndash International Federation for Clinical Chemistry
IMF ndash meranie fluorescencie po značeniacute buniek protilaacutetkami
KOAG ndash Coagulation Point Detection Method
KRAS ndash označenie geacutenu kt somatickeacute mutaacutecie v suacute predikatiacutevnym markerom pri metastazujuacutecom ca hrubeacuteho čreva
LATEX ndash Latex immunoassay method
MLH1 - označenie geacutenu asociovaneacuteho s dedičnou formou kolorektaacutelneho karcinoacutemu
MSH2 - označenie geacutenu asociovaneacuteho s dedičnou formou kolorektaacutelneho karcinoacutemu
NRAS ndash označenie geacutenu kt somatickeacute mutaacutecie v suacute predikatiacutevnym markerom pri metastazujuacutecom ca hrubeacuteho čreva
OHT - Oddelenie hematoloacutegie a transfuzioloacutegie
OID ndash Oddelenie imunodiagnostiky
OKB ndash Oddelenie klinickej biocheacutemie
OKIA - Oddelenie klinickej imunoloacutegie a alergoloacutegie
OKPC - Oddelenie klinickej patoloacutegie a cytoloacutegie
OLG ndash Oddelenie lekaacuterskej genetiky
PAP ndash peroxidaacuteza
PCR ndash polymeraacutezovaacute reťazovaacute reakcia
PHOTO ndash spektrofotometrickaacute metoacuteda
PLP ndash pyridoxalfosfaacutet
POD ndash peroxidaacuteza
RET ndash označenie geacutenu v dedičnej forme medulaacuterneho karcinoacutemu a syndroacutemu mnohopočetnej endokrinnej neoplaacutezie typu 2
RIA - Radio Immunoassay
RT - Real-Time
ŠPP ndash Štandardnyacute pracovnyacute postup
TPO ndash Tyreoidaacutelna peroxidaacuteza
TRACE ndash Time Resolved Amplified Cryptate Emission
6 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Polo
žka Objekt skuacutešky Zavedenaacute metoacuteda
Ostatneacute
špecifikaacutecie Systeacutem
Biologickyacute
materiaacutel
Ukazovateľ
Analyt
Parameter
Princiacutep
Druh
Typ
Označenie
4 seacuterum Stanovenie
špecifickyacutech IgE
SIGE - Stanovenie
špecifickyacutech IgE
Enzyacutemovaacute
imunoanalyacuteza
HY-TEC Specific IgE
HYCOR
(ŠPP OKIA41)
SIGE - Stanovenie
špecifickyacutech IgE
FEIA
(Fluorescenčnaacute
enzyacutemovaacute
imunoanalyacuteza)
ImmunoCAPregSpecific
IgE Phadia
(ŠPP OKIA4 2 )
5 seacuterum
Stanovenie parametrov humoraacutelnej odpovede
Enzyacutemovaacute
imunoanalyacuteza
DSX
potravinoveacute
intolerancie
GLIAA Stanovenie protilaacutetok
triedy IgA proti gliadiacutenu
Anti-Gliadin (GAF-3X)
ELISA-(IgA) Euroimmun
(ŠPP OKIA513)
GLIAG Stanovenie protilaacutetok
triedy IgG proti gliadiacutenu
Anti-Gliadin (GAF-3X)
ELISA-(IgG) Euroimmun
(ŠPP OKIA514)
TTG A Stanovenie protilaacutetok
triedy IgA proti tkanivovej
transglutaminaacuteze
Protilaacutetky proti tkaňoveacute
transglutamnaacuteze ELISA
(IgA) Euroimmun
(ŠPP OKIA515)
ASCA Stanovenie protilaacutetok
triedy IgA proti
Saccharomyces cerevisiae
EIA Anti-ASCA IgA
AIDA
(ŠPP anti-ASCA IgA
516)
ASCAG Stanovenie
protilaacutetok triedy IgG proti
Saccharomyces cerevisiae
EIA Anti-ASCA IgG
AIDA
(ŠPP anti-ASCA IgG
517)
autoprotilaacutetky
RFC Stanovenie protilaacutetok
triedy IgA IgM IgM proti
reumatoidneacutemu faktoru
Rf-Check AIDA
(ŠPP OKIA522)
CCP Stanovenie protilaacutetok
proti cyklickeacutemu
citruliacutenoveacutemu proteiacutenu
RACP Detect AIDA
(ŠPP OKIA523)
6 seacuterum
plazma
Stanovenie
zložiek
komplementu
C1F Vyšetrenie funkčnej
aktivity C1 inhibiacutetora
Enzyacutemovaacute
imunoanalyacuteza
A003-MicroVue C1-
Inhibitor Plus EIA Kit
Quidel (ŠPP OKIA61)
Oddelenie klinickej patoloacutegie a cytoloacutegie -OKPC Uacutestav patoloacutegie SZU a OUacuteSA
Polo
žka Objekt skuacutešky Zavedenaacute metoacuteda
Ostatneacute
špecifikaacutecie Systeacutem
Biologickyacute
materiaacutel
Analyt
Ukazovateľ
Princiacutep
Druh
Typ
Označenie
Oddelenie klinickej patoloacutegie a cytoloacutegie -OKPC
1 tkanivo histopatologickeacute
zmeny
Histologickeacute
vyšetrenie tkaniva
(biopsia)
ŠPP OKPC01
ŠPP OKPC02
ŠPP OKPC03
ŠPP OKPC04
(Literatuacutera viď
priacuteloha č 4)
histoloacutegia peroperačneacute biopsie spracovanie
tvrdyacutech tkaniacutev histocheacutemia 1
imunohistocheacutemia 2 mikroskopickeacute hodnotenie
2
moč
vyacutepotok
otlačok
ascitickaacute
tekutina naacuteter
PAB (punkčnaacute
aspiračnaacute
biopsia)
cytopatologickeacute
zmeny
cytologickeacute
vyšetrenie
negynekolo-gickeacute
ŠPP OKPC05
(Literatuacutera viď
priacuteloha č 4)
farbenie naacuteterov polychromatickou metoacutedou
podľa Papanicolaua13
mikroskopickaacute diagnostika
7 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Polo
žka Objekt skuacutešky Zavedenaacute metoacuteda
Ostatneacute
špecifikaacutecie Systeacutem
Biologickyacute
materiaacutel
Analyt
Ukazovateľ
Princiacutep
Druh
Typ
Označenie
3
gynekologickyacute
ster materiaacutel
odobratyacute na
Liquid based
cytology (LBC)
cytopatologickeacute
zmeny
cytologickeacute
vyšetrenie
gynekologickeacute
Liquid based
cytology (LBC)
ŠPP OKPC06
(Literatuacutera viď
priacuteloha č 4)
farbenie naacuteterov polychromatickou metoacutedou
podľa Papanicolaua3 imunocytocheacutemia
mikroskopickaacute diagnostika
systeacutem diagnostickeacuteho hodnotenia gynekologickej
cytoloacutegie Bethesda 2001
1 Priacuteloha 1 Zoznam histochemickyacutech farbiacich a impregnačnyacutech metoacuted na OKPC UacuteP
1 Farbenie hematoxyliacutenom-eoziacutenom
2 Docirckaz polysacharidov PAS reakciou podľa Mc Manusa
3 Farbenie HP podľa Giemsu
4 Impregnaacutecia podľa Gomoriho
5 Farbenie kolageacutenvyacutech vlaacutekien podľa van Giesona
6 Docirckaz železa Perlsovou reakciou
7 Amyloid kongočerveňou podľa Puchtlerovej
8 Impregnačnaacute metoacuteda podľa Grimeliusa
9 Mallory - farbenie na fibriacuten
10 Kysleacute mukopolysacharidy - Alciaacutenovaacute modraacute
11 Farbenie na docirckaz Melaniacutenu podľa Lignaca
12 Mucikarmiacuten podľa Mayera
13 Docirckaz Mycbacterium tuberculosis podľa Ziehl-Neelsena
14 Bakteacuterie podľa Gramma
15 Docirckaz glykogeacutenu metoacutedou PAS-diastaacuteza
16 Zelenyacute Trichroacutem podľa Massona
17 Docirckaz lipidov podľa Lillieho
18 Rezorciacuten-fuchsiacuten podľa Weigerta na elastickeacute vlaacutekna
19 Docirckaz plesniacute ndash impregnačnaacute metoacuteda podľa Gomoriho
20 Kombinovanaacute metoacuteda PAS ndash Alciaacutenovaacute modraacute
2 Priacuteloha 2 Zoznam všetkyacutech antigeacutenov vyšetrovanyacutech imunohistochemickou metoacutedou na OKPC UacuteP
Protilaacutetka proti antigeacutenu Skratka Vyacuterobca
Aktiacuten (smooth muscle) ASM Dako
Alfa-1-fetoproteiacuten AFP Dako
Androgeacutenovyacute receptor AR Novocastra
Bcl-2 BCL2 Dako
Βetacatenin BCAT Dako
Caldesmon CDES Dako
Calretinin CRT Dako
CD10 CD10 Novocastra
CD20cy CD20 L26 Dako
CD30 CD30 Dako
CD31 CD31 Dako
CD34 Class II CD34 Dako
CD45 CD45 LCA Dako
CD45RO CD45RO UCHL1 Dako
CD56 CD56 Dako
CD68 CD68 Novocastra
CD99 CD99 Dako
CD117 CD117 Dako
CDX2 CDX2 Dako
Cytokeratiacuten 56 CK56 Dako
Cytokeratiacuten 7 CK7 Novocastra
Cytokeratiacuten 18 CK18 Dako
Cytokeratiacuten 19 CK19 Dako
Cytokeratiacuten 20 CK20 Novocastra
Cytokeratiacuten AE1AE3 AE13 Dako
Cytokeratiacuten HMW CKHMW Dako
Dezmiacuten DEZ Novocastra
EGFR EGFR Dako
E-kadheriacuten CAD Dako
Epitelovyacute membraacutenovyacute antigeacuten EMA Dako
Estrogeacutenovyacute receptor ER Novocastra
Gastrin GAST Dako
Glukagon GLUK Dako
Gross cystic disease fluid protein-15 GCDF Dako
Ľudskyacute choriogonadotropiacuten HCG Dako
Helicobacter pylori HP Dako
Hepatocyte HEP Dako
HER2 HER2 Dako
Chromograniacuten A CHROM Dako
8 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Inhibiacuten INH Novocastra
Inzuliacuten INZ Dako
Kalcitoniacuten KALC Dako
Kappa light chains IgK Dako
Karbonickaacute anhydraacuteza IX CAIX BioScience
Karcinoembryonaacutelny antigeacuten (monoklonaacutelna) CEA Dako
Ki-67 Ki-67 Novocastra
Lambda light chains IgL Dako
Mammaglobin MAM Dako
Melan A MELAN Dako
Melanozoacutem HMB45 Dako
Mismatch repair protein MLH1 MLH1 Novocastra
Mismatch repair protein MSH2 MSH2 Novocastra
Mismatch repair protein MSH6 MSH6 Dako
Mismatch repair protein PMS2 PMS2 Dako
Myogenin MG Dako
Enolaacuteza špecifickaacute pre neuroacuteny NSE Dako
OCT34 OCT34 Novocastra
Placentaacuterna alkalickaacute fosfataacuteza PLAP Novocastra
p16 p16 Santa Cruz Biotechnology
p53 p53 Novocastra
p63 p63 Dako
-metyl-CoA Racemaacuteza AMACR Dako
Progesteroacutenovyacute receptor PR Novocastra
Prostatickyacute špecifickyacute antigeacuten PSA Dako
Serotonin SRT Dako
Somatostatin SOM Dako
S-100 S-100 Dako
Synaptofyziacuten SYN Novocastra
Tyreoglobuliacuten THG Dako
Tyreoidnyacute transkripčnyacute faktor -1 TTF-1 Dako
Vimentiacuten VIM Dako
WT1 WT1 Dako
3 Priacuteloha 3 Zoznam cytochemickyacutech farbeniacute použiacutevanyacutech na UacuteP
1 Farbenie hematoxyliacutenom-eoziacutenom
2 Farbenie podľa Giemsa ndash Romanowski
3 Farbenie podľa Papanicolaoua ndash polychroacutem EA-50 (PAP)
4 Imunocytochemickeacute vyšetrenie antigeacutenu p16 a Ki67
4 Priacuteloha 4 Zoznam použitej literatuacutery
Literatuacutera použitaacute v ŠPP OKPC01
1 Rosai and Ackerman Surgical Pathology ed Juan Rosai 9 vyd Mosby Elsevier inc 2004
2 Leverrsquos Histopathology of the Skin ed David E Elder 9 vyd Lippincott WilliamsampWilkins 2005
3 Vacek Z Histologie a histologickaacute technika 1 vyd Institut pro dalšiacute vzdělaacutevaacuteniacute pracovniacuteků ve zdravotnictviacute 1996
4 Mezinaacuterodniacute klasifikace nemociacute pro onkologii 3 vyd Světovaacute zdravotnickaacute organizace 2000
5 Pathology and Genetics of Tumours of Haematopoietic and Lymphoid Tissues ed Elaine S Jaffe Nancy Lee Harris Harald Stein James W
Vardiman IARCPress 2001
6 Pathology and Genetics of Tumours of the Breast and Female Genital Organs ed Fattaneh A Tavassoli Peter Devilee IARCPress 2003
7 Pathology and Genetics of Tumours of the Digestive System ed Stanley R Hamilton Lauri A Aaltonen IARCPress 2000
8 Pathology and Genetics of Tumours of Soft Tissue and Bone ed Christopher D M Fletcher K Krishnan Unni Fredrik Mertens IARCPress 2002
9 Pathology and Genetics of Tumours of the Urinary System and Male Genital Organs ed John N Eble Guido Sauter Jonathan I Epstein Isabell A
Sesterhenn IARCPress 2004
10 Pathology and Genetics of Tumours of the Nervous System ed Paul Kleihnes Webster K Cavenee IARCPress 2000
11 Blausteinrsquos Pathology of the Female Genital Tract ed Robert J Kurman Springer-Verlag New York 2002
12 Rosen P P Rosenrsquos Breast Pathology Lippincott WilliamsampWilkins 2001
Literatuacutera použitaacute v ŠPP OKPC02
1 Čunderliacutekovaacute M Balaacutežovaacute V Vybraneacute kapitoly z histologickej techniky Vydavateľstvo Osveta 1990 s167 ISBN 80-217-0269-9
2 Vacek Z Histologie a histologickaacute technika 1 vyd Institut pro dalšiacute vzdělaacutevaacuteniacute pracovniacuteků ve zdravotnictviacute 1996
3 Susan C Lester Manual of Surgical Pathology 2 edition Elsevier Churchill Livingstone 2006
4 Bancroft JD Gamble M Theory and practice of histological techniques Churchil-Livingstone 6th edition 2008 ISBN978-0-443-10279-0 s725
5 Callis GM Bone In Bancroft JD Gamble M Theory and practice of histological techniques Churchil-Livingstone 6th edition 2008 s333 ndash
363
Literatuacutera použitaacute v ŠPP OKPC03
1 Susan C Lester Manual of Surgical Pathology 2 edition Elsevier Churchill Livingstone 2006
2 Rosai and Ackerman Surgical Pathology ed Juan Rosai 9 vyd Mosby Elsevier inc 2004
3 Leverrsquos Histopathology of the Skin ed David E Elder 9 vyd Lippincott WilliamsampWilkins 2005
4 Vacek Z Histologie a histologickaacute technika 1 vyd Institut pro dalšiacute vzdělaacutevaacuteniacute pracovniacuteků ve zdravotnictviacute 1996
5 Mezinaacuterodniacute klasifikace nemociacute pro onkologii 3 vyd Světovaacute zdravotnickaacute organizace 2000
6 Pathology and Genetics of Tumours of Haematopoietic and Lymphoid Tissues ed Elaine S Jaffe Nancy Lee Harris Harald Stein James W
Vardiman IARCPress 2001
9 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
7 Pathology and Genetics of Tumours of the Breast and Female Genital Organs ed Fattaneh ATavassoli Peter Devilee IARCPress 2003
8 Pathology and Genetics of Tumours of the Digestive System ed Stanley R Hamilton Lauri A Aaltonen IARCPress 2000
9 Pathology and Genetics of Tumours of Soft Tissue and Bone ed Christopher D M
10 Fletcher K Krishnan Unni Fredrik Mertens IARCPress 2002
11 Pathology and Genetics of Tumours of the Urinary System and Male Genital Organs ed John N Eble Guido Sauter Jonathan I Epstein Isabell A
Sesterhenn IARCPress 2004
12 Pathology and Genetics of Tumours of the Nervous System ed Paul Kleihnes Webster K Cavenee IARCPress 2000
13 Blausteinrsquos Pathology of the Female Genital Tract ed Robert J Kurman Springer-Verlag
New York 2002
14 Rosen P P Rosenrsquos Breast Pathology Lippincott WilliamsampWilkins 2001
Literatuacutera použitaacute v ŠPP OKPC04
1 Gomolčaacutek P Zaacuteklady imunohistocheacutemie v patoloacutegii IDVPZ Brno 1997 92 s ISBN 80-7013-239-6
2 Key M et al Immunohistochemical staining methods fourth edition education guide DAKO corporatio Carpinteacuteria California 2006 174 s
3 Lukaacuteš Z Draacuteberovaacute E Feit J Vojtěšek B Imunohistochemickeacute metody v biologii a v bioptickeacute diagnostice Acta facultatis medicae Universitatis
Masarykianae Brunensis Sborniacutek praciacute LF v Brně č 112 LF Masarykovy University Brno 1997 147 s ISBN 80-210-0620-X
4 Taylor CR Cote RJ Immunomicroscopy a diagnostic tool for the surgical pathologist third edition Saunders Elsevier 2006 531 s ISBN
0721601820
5 httpwwwihcworldcom
6 httpdistdakocom
7 Shi S-R Key ME Kalra KL Antigen retrieval in formalinfixed paraffin-embedded tissues an enhancement method for immunohistochemical
staining based on microwave oven heating of tissue sections J Histochem Cytochem 1991 39(6) 741-748
8 Shi S-R Cote RJ Taylor CR Antigen retrieval immunohistochemistry past present and future J Histochem Cytochem 1997 45 (3) 327-343
9 Miller RT Technical immunohistochemistry achieving reliability and reproducibility of immunostains [online] New York Society for Applied
Immunohistochemistry Annual Meeting 2001 [cit 2008-12-12] Dostupneacute na lthttpwwwihcworldcom_booksTechnical-IHCpdfgt
Literatuacutera použitaacute v ŠPP OKPC05
1 WiedGKeebler CM Koos LG Patten SFRosenthal DL Compendium on Diagnostic Cytology
2 Richard M De May The Art and Science of Cytopathology
3 Adam P Taborskyacute L Sobek O Kolbich PCytogy of cerebrospinal fluid
4 Takahashi MColor atlas of cancer cytology
Literatuacutera použitaacute v ŠPP OKPC06
1 WiedGKeebler CM Koos LG Patten SFRosenthal DL Compendium on Diagnostic Cytology
2 Richard M De May The Art and Science of Cytopathology
3 JKobilkovaacute JSirackyacute a kolCytodiagnostika v gynekologii
4 JKobilkovaacuteZLojdaJOndrušABekovaacute Gynekologickaacute cytodiagnostika
5 JKobilkovaacute Zaacuteklady cytopatoloacutegie
10 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Flexibilnyacute rozsah akreditaacutecie
Naacutezov akreditovaneacuteho subjektu Onkologickyacute uacutestav sv Alžbety sro
Heydukova 10 812 50 Bratislava
Uacutestav laboratoacuternej mediciacuteny SZU a OUacuteSA
Oddelenie lekaacuterskej genetiky
Flexibilnyacute rozsah akreditaacutecie je zverejnenyacute na adrese
httpwwwousask_imgDocumentsDocumentyZoznam_akreditovanych_cinnostipdf
Polo
žka Objekt skuacutešky Zavedenaacute metoacuteda
Ostatneacute
špecifikaacutecie Systeacutem
Biologickyacute
materiaacutel
Analyt
Ukazovateľ
Princiacutep
Druh
Typ
Označenie
1 Analyacuteza germinatiacutevnych variantov
11
Ľudskaacute
perifeacuterna krv
-Germinatiacutevne varianty v geacutene
BRCA12
Izolaacutecia DNA
PCR
amplifikaacutecia
Sekvenačnaacute
analyacuteza
ŠPP OLG1
(dolu uved orig
praacutece)
Kvalitatiacutevna skuacuteška
12 -Germinatiacutevne varianty v geacutene RET
Izolaacutecia DNA
PCR
amplifikaacutecia
Sekvenačnaacute
analyacuteza
ŠPP OLG2
(dolu uved orig
praacutece)
13 - - Docirckaz germinatiacutevnych variantov v
geacutene MLH1 a MSH2
Izolaacutecia DNA
PCR
amplifikaacutecia
Sekvenačnaacute
analyacuteza
ŠPP OLG10
(dolu uved orig
praacutece)
14 - - Docirckaz germinatiacutevnych variantov
v geacutene VHL
Izolaacutecia DNA
PCR
amplifikaacutecia
Sekvenačnaacute
analyacuteza
SPP OLG14
(dolu uvedeneacute
origpraacutece)
15
- - Docirckaz germinatiacutevnych variantov
v paneli geacutenov asociovanyacutech
s onkologickyacutemi hereditaacuternymi
syndroacutemami
Izolaacutecia DNA
PCR
amplifikaacutecia
Sekvenačnaacute
analyacuteza
SPP OLG15
(dolu uvedeneacute
origpraacutece)
2 Analyacuteza somatickyacutech variantov
21
Fixovaneacute
natiacutevne tkanivo
- Docirckaz somatickyacutech variantov
v exoacutenoch 2 3 a 4 geacutenu KRAS a
NRAS pri naacutedoroch kolorekta
Izolaacutecia DNA
PCR
amplifikaacutecia
Mini-sekvenačnaacute
analyacuteza
Real-Time PCR
ŠPP OLG5
(dolu uved orig
praacutece)
Kvalitatiacutevna skuacuteška 22
- Docirckaz somatickyacutech variantov
v kodoacutene 600 geacutenu BRAF pri
naacutedoroch štiacutetnej žľazy a maliacutegnom
melanoacuteme
Izolaacutecia DNA
PCR
amplifikaacutecia
Mini-sekvenačnaacute
analyacuteza
Real-Time PCR
ŠPP OLG9
(dolu uved orig
praacutece)
ŠPP OLG5
(dolu uved orig
praacutece)
23
Fixovaneacute
natiacutevne
tkanivocytologi
ckeacute stery
- Docirckaz somatickyacutech variantov
v exoacutenoch 18 19 20 a 21 geacutenu
EGFR pri nemalobunkovom
karcinoacuteme pľuacutec
Izolaacutecia DNA
PCR
amplifikaacutecia
Mini-sekvenačnaacute
analyacuteza
Real-Time PCR
ŠPP OLG11
(dolu uved orig
praacutece)
ŠPP OLG5
(dolu uved orig
praacutece)
11 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Polo
žka Objekt skuacutešky Zavedenaacute metoacuteda
Ostatneacute
špecifikaacutecie Systeacutem
Biologickyacute
materiaacutel
Analyt
Ukazovateľ
Princiacutep
Druh
Typ
Označenie
24 Fixovaneacute
natiacutevne tkanivo
-Docirckaz somatickyacutech variantov
v geacutene BRCA12
Izolaacutecia DNA
PCR
amplifikaacutecia
Sekvenačnaacute
analyacuteza
Mini-skevenačnaacute
analyacuteza
ŠPP OLG16
(dolu uved orig
praacutece)
Kvalitatiacutevna skuacuteška
4 Genotypizaacutecia ľudskyacutech papilomaviacuterusov
41
Bunkovaacute
suzpenzia
fixovaneacute
tkanivo
perifeacuterna krv
-Genotypizaacutecia HPV
Izolaacutecia DNA
PCR
amplifikaacutecia
Real-Time PCR
ŠPP OLG3
(dolu uved orig
praacutece)
Kvalitatiacutevna skuacuteška
5 Docirckaz priacutetomnosti HPV
51 Bunkovaacute
suzpenzia -Docirckaz priacutetomnosti HPV
Izolaacutecia DNA
Real-Time PCR
ŠPP OLG13
(dolu uved orig
praacutece)
Kvalitatiacutevna skuacuteška
6 Docirckaz veľkyacutech geacutenovyacutech prestavieb v geacutenoch asociovanyacutech s onkologickyacutemi hereditaacuternymi syndroacutemami metoacutedou MLPA
61
Ľudskaacute
perifeacuterna krv
Fixovaneacute
natiacutevne tkanivo
- - Docirckaz veľkyacutech geacutenovyacutech
prestavieb v geacutenoch asociovanyacutech s
onkologickyacutemi hereditaacuternymi
syndroacutemami metoacutedou MLPA
Izolaacutecia DNA
PCR
amplifikaacutecia
Fragmentačnaacute
analyacuteza
SPP OLG17
(dolu uvedeneacute
origpraacutece)
Kvalitatiacutevna skuacuteška
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG1
1 Friedman L Ostermeyer E A Szabo CI a kol Confirmation of BRCA1 by analysis of germline mutations linked to breast and ovarian cancer in
ten families Nat Genetics 8 399-404 1994
2 Miki Y Katagiri T Kasumi F a kol Mutation analysis in the BRCA2 gene in primary breast cancer Nat Genetics 2 245-7 1996
3 Wagner T M U Hirtenlehner K Shen P a kol Global sequence diversity of BRCA2 analysis of 71 breast cancer families and 95 control
individuals of worldwilde populatins Hum Mol Genetocs Vol 8 No 3 1999
4 QIAamp DNA Mini Kit and OIAamp DNA Blood Mini Kit Handbook
5 Nanodrop ND 1000 useracutes manual
6 Promega Protocols and applications guide The Source for Discovery PCR cheapter Promega Corporation USA 1996
7 Amersham Pharmacia Biotech DNA Silver Staining Kit instructions
8 BigDye Terminator v 11 Cycle Sequencing Kit Protokol Applied Biosystems
9 Applied Biosystems DNA Sequencing Analysis Software Version 51 for Windows XP and 2000 Platforms User Guide Applied Biosystems
10 Applied Biosystems 31303130xl Genetic Analyzers Getting Started Guide Applied Biosystems
11 Konecny M et al Comprehensive genetic characterization of hereditary breastovarian cancer families from Slovakia Breast Cancer Res Treat
(2011) 126119ndash130
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG2
1 Ceccherini I Hofstra RMW Luo Y a kol DNA polymorphisms and conditions for SSCP analysis of the 20 exons of the RET proto-oncogene
Oncogene 9 3025-3029 1994
2 De Groot et al RET as a dignostic and therapeutic target in sporadic and hereditary endocrine tumors 2006 Endocrine Reviews 27(5) 535-560
3 Martucciello G Lerone M et al Multiple endocrine neoplasias type 2B and RET proto-oncogene Ital J Pediatr 2012 Mar 19389 doi
1011861824-7288-38-9 Review
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG3
1 Weismanovaacute E Weismann P Vizvaacuteryovaacute M a kol New approach to human high-risk papillomavirus (HR-HPV) genotyping Neoplasma 49
217-224 2002
2 Amersham Biosciences GenomicPrep Cells and Tissue DNA Isolation Kit instructions
3 Amersham Pharmacia Biotech QuickPrep Total RNA Extraction Kit instructions
4 Amersham Pharmacia Biotech Ready To Go You-Prime First-Strand Beads instructions
5 Amersham Pharmacia Biotech Ready To Go PCR Beads instructions
6 Amersham Pharmacia Biotech DNA Silver Staining Kit instructions
7 F-HPV typingTM Kit Manual
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG5
1 Van Krieken J H J M Jung A Kirchner T a kol KRAS mutation testing for predicting response to anti-EGFR therapy for colorectal carcinoma
proposal for an European quality assurance program Virchows Arch (2008) 453417-431
2 Lievre A Bachet J Le Corre D a kol KRAS mutation status is predictive of response to cetuximab therapy in colorectal cancer Cancer Res
(2006) 668
3 TheraScreen K-RAS Mutation Manual
4 BigDye Terminator v 11 Cycle Sequencing Kit Protokol Applied Biosystems
5 Applied Biosystems DNA Sequencing Analysis Software Version 51 for Windows XP and 2000 Platforms User Guide Applied Biosystems
6 Applied Biosystems 3500 Genetic Analyzers Getting Started Guide Applied Biosystems
8 SNaPshot Multiplex Kit ndash protocol and manual
12 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG9 1 Nikiforov YE thyroid carcinoma molecular pathways and therapeutic targets Modern pathology 21S37-S43 2008
2 Elisei R Ugolini C Viola D Lupi C et al BRAF V600E mutation and outcome of patients with papillary thyroid carcinoma
A 15-year median follow-up study J Clin endocrine Metab 93(10)3943-3949 2008
3 SNaPshot Multiplex Kit ndash protocol and manual Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG10
1 Brigitte Wolf Silvia Henglmueller at al Spectrum of germ-line MLH1 and MSH2 mutations in Austrian patientswith hereditary nonpolyposis
colorectal cancer The Middle European Journal of Medicine 2005 1177ndash8 269ndash277
2 Elisabeth mangold Constanze Pagenstecher et al Spectrum and frequencies of mutations in MSH2 and MLH1 identified in 1721 german families
suspected of hereditary nonpolyposis colorectal cancer Int J Cancer 2005 116 692-702
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG11
1 Rosell R Moran T Queralt C Porta R Cardenal F Camps C Majem M Lopez-Vivanco G Isla D Provencio M Insa A Massuti
B Gonzalez-Larriba J L Paz-Ares L Bover I Garcia-Campelo R Moreno M A Catot S Rolfo C Reguart N Palmero R Sanchez
JM Bastus R Mayo C Bertran- Alamillo J Molina M A Sanchez J J Taron M (2009) Screening for epidermal growth factor receptor
mutations in lung cancer N Engl J Med 361 958-967
2 Peacuterez-Soler R Chachoua A Hammond L A Rowinsky E K Huberman M Karp M Rigas J Clark G M Santabaacuterbara P Bonomi P
(2004) Determinants of Tumor Response and Survival With Erlotinib in Patients With NonndashSmall-Cell Lung Cancer Journal og Clinical
Oncology 22 16
3 Pines G Koumlstler W JYosef Yarden Department of Biological Regulation The Weizmann Institute of Science Rehovot 76100 Israel (2010)
Oncogenic mutant forms of EGFR lessons in signal transduction and targets for cancer therapy FEBSLett 584 (12) 2699ndash2706
4 ABI PRISM SnaPshot Multiplex Kit ndashProtocol and manual
5 cobasreg EGFR Mutation Test ndash User Manual
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG13
1 cobasreg 4800 HPV Test ndash Dokument č 05990343001-04SK Roche Diagnostics GmbH
2cobasreg 4800 HPV Test ndash Dokument č 05641268001-01 Roche Molecular Systems Inc
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG14
1 Nielsen SM Rhodes L Blanco I a kol 2016 Von Hippel-Lindau Disease Genetics and Role of Genetic Counseling in a Multiple Neoplasia
Syndrome J Clin Oncol 34(18)2172-2181
2 Alberta Health Services 2011 Renal cell carcinoma and genetic testing Clinical Practice Guideline GU-005
3 Chittiboina P Lonser RR 2015 Von Hippel-Lindau disease Handb Clin Neurol132139-156
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG15
1 Hereditary Cancer Solution by Sophia Genetics ndash Users guide using DNA library prep kit by Sophia genetics 48 samples
2 BRCA Hereditary Cancer MASTR Plus kit with drMID for Ilumina NGS systems ndash instructions for use
3 Crawford B Adams S B Sittler et al (2017) Multi-gene panel testing for hereditary cancer predisposition in unsolved high-risk breast and ovarian
cancer patients Breast cancer research and treatment 163(2) 383-390
4 Grissom A A Friend P J (2016) Multigene Panel Testing for Hereditary Cancer Risk Journal of the advanced practitioner in oncology 7(4) 394-
407
5 Lorans M Dow E Macrae FA Winship IM Buchanan DD (2018) Update on Hereditary Colorectal Cancer Improving the Clinical Utility of
Multigene Panel Testing Clin Colorectal Cancer 17(2)e293-e305
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG16
1 Ledermann PARP inhibitors in ovarian cancer Annals of Oncology (2016) 27 i40ndashi44
2 Koczkowska M et al Detection of somatic BRCA12 mutations in ovarian cancer - next-generation sequencing analysis of 100 cases Cancer Med
2016 Jul5(7)1640-6
3 Dougherty BA et al Biological and clinical evidence for somatic mutations in BRCA1 and BRCA2 as predictive markers for olaparib response in
high-grade serous ovarian cancers in the maintenance setting Oncotarget 2017 Jul 48(27)43653-43661
4 Maxwell KN et al BRCA locus-specific loss of heterozygosity in germline BRCA1 and BRCA2 carriers Nat Commun 2017 Aug 228(1)319
5 httpswwwagilentcomcslibrarybrochuresBrochure20Complete20solution20BRCA20MASTR20(Plus)20Dx20v1708pdf
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG17
1 MRC-Holland ndash MLPA General Protocol httpswwwmlpacom
2 Ticha I Kleibl Z Stribrna J a kol Screening for genomic rearragements in a genes in Czech high-risk breastovarian cancer patients high
proportion of population specific alterations in gene Breast Cancer Research and Treatment 2010 124 (2)337-347
3 Sluiter MD van Rensburg EJ Large genomic rearragements of the BRCA1 and BRCA2 genes review of the literature and report of a novel BRCA1
mutation Breast Cancer Research and Treatment 2011 125 325-349
Osoby spocircsobileacute modifikovať a validovať metoacutedy na Oddeleniacute lekaacuterskej genetiky
Meno a priezvisko tituly Spocircsobilosť modifikovať a validovať metoacutedy
ndash čiacuteslo položky v rozsahu akreditaacutecie
Regiacutena Lohajovaacute Behulovaacute RNDr PhD 11 až 61
Katariacutena Zaacutevodnaacute RNDr PhD 11 až 61
Ľudmila Vavrovaacute Ing PhD 11 až 61
Tomaacuteš Slamka Mgr 11 až 61
Lukaacuteš Šebest Mgr PhD 11 až 61
Aster Alemayehu RNDr PhD 11 až 61
13 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Použiteacute skratky
AGLUT ndash aglutinačnaacute reakcia
AOD ndash askorbaacutetoxidaacuteza
BRCA ndash označenie geacutenu asociovaneacuteho s dedičnou formou mamaacuternehoovariaacutelneho karcinoacutemu
CDKN2A ndash označenie geacutenu asociovaneacuteho s dedičnou formou maliacutegneho melanoacutemu
E6E7 - HPV viacuterusoveacute onkogeacuteny asociovaneacute so vznikom a progresiou Ca krčka maternice
FOTO - fotometria
GLD ndash glutamaacutetdehydrogenaacuteza
GPO ndash glycerol-3-fosfaacutet-oxidaacuteza
HPLC ndash High Performance Liquid Chromatography
HPV ndash human papillomavirus (ľudskyacute papilloma viacuterus)
CHOD ndash cholesteroloxidaacuteza
IFCC ndash International Federation for Clinical Chemistry
IMF ndash meranie fluorescencie po značeniacute buniek protilaacutetkami
KOAG ndash Coagulation Point Detection Method
KRAS ndash označenie geacutenu kt somatickeacute mutaacutecie v suacute predikatiacutevnym markerom pri metastazujuacutecom ca hrubeacuteho čreva
LATEX ndash Latex immunoassay method
MLH1 - označenie geacutenu asociovaneacuteho s dedičnou formou kolorektaacutelneho karcinoacutemu
MSH2 - označenie geacutenu asociovaneacuteho s dedičnou formou kolorektaacutelneho karcinoacutemu
NRAS ndash označenie geacutenu kt somatickeacute mutaacutecie v suacute predikatiacutevnym markerom pri metastazujuacutecom ca hrubeacuteho čreva
OHT - Oddelenie hematoloacutegie a transfuzioloacutegie
OID ndash Oddelenie imunodiagnostiky
OKB ndash Oddelenie klinickej biocheacutemie
OKIA - Oddelenie klinickej imunoloacutegie a alergoloacutegie
OKPC - Oddelenie klinickej patoloacutegie a cytoloacutegie
OLG ndash Oddelenie lekaacuterskej genetiky
PAP ndash peroxidaacuteza
PCR ndash polymeraacutezovaacute reťazovaacute reakcia
PHOTO ndash spektrofotometrickaacute metoacuteda
PLP ndash pyridoxalfosfaacutet
POD ndash peroxidaacuteza
RET ndash označenie geacutenu v dedičnej forme medulaacuterneho karcinoacutemu a syndroacutemu mnohopočetnej endokrinnej neoplaacutezie typu 2
RIA - Radio Immunoassay
RT - Real-Time
ŠPP ndash Štandardnyacute pracovnyacute postup
TPO ndash Tyreoidaacutelna peroxidaacuteza
TRACE ndash Time Resolved Amplified Cryptate Emission
7 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Polo
žka Objekt skuacutešky Zavedenaacute metoacuteda
Ostatneacute
špecifikaacutecie Systeacutem
Biologickyacute
materiaacutel
Analyt
Ukazovateľ
Princiacutep
Druh
Typ
Označenie
3
gynekologickyacute
ster materiaacutel
odobratyacute na
Liquid based
cytology (LBC)
cytopatologickeacute
zmeny
cytologickeacute
vyšetrenie
gynekologickeacute
Liquid based
cytology (LBC)
ŠPP OKPC06
(Literatuacutera viď
priacuteloha č 4)
farbenie naacuteterov polychromatickou metoacutedou
podľa Papanicolaua3 imunocytocheacutemia
mikroskopickaacute diagnostika
systeacutem diagnostickeacuteho hodnotenia gynekologickej
cytoloacutegie Bethesda 2001
1 Priacuteloha 1 Zoznam histochemickyacutech farbiacich a impregnačnyacutech metoacuted na OKPC UacuteP
1 Farbenie hematoxyliacutenom-eoziacutenom
2 Docirckaz polysacharidov PAS reakciou podľa Mc Manusa
3 Farbenie HP podľa Giemsu
4 Impregnaacutecia podľa Gomoriho
5 Farbenie kolageacutenvyacutech vlaacutekien podľa van Giesona
6 Docirckaz železa Perlsovou reakciou
7 Amyloid kongočerveňou podľa Puchtlerovej
8 Impregnačnaacute metoacuteda podľa Grimeliusa
9 Mallory - farbenie na fibriacuten
10 Kysleacute mukopolysacharidy - Alciaacutenovaacute modraacute
11 Farbenie na docirckaz Melaniacutenu podľa Lignaca
12 Mucikarmiacuten podľa Mayera
13 Docirckaz Mycbacterium tuberculosis podľa Ziehl-Neelsena
14 Bakteacuterie podľa Gramma
15 Docirckaz glykogeacutenu metoacutedou PAS-diastaacuteza
16 Zelenyacute Trichroacutem podľa Massona
17 Docirckaz lipidov podľa Lillieho
18 Rezorciacuten-fuchsiacuten podľa Weigerta na elastickeacute vlaacutekna
19 Docirckaz plesniacute ndash impregnačnaacute metoacuteda podľa Gomoriho
20 Kombinovanaacute metoacuteda PAS ndash Alciaacutenovaacute modraacute
2 Priacuteloha 2 Zoznam všetkyacutech antigeacutenov vyšetrovanyacutech imunohistochemickou metoacutedou na OKPC UacuteP
Protilaacutetka proti antigeacutenu Skratka Vyacuterobca
Aktiacuten (smooth muscle) ASM Dako
Alfa-1-fetoproteiacuten AFP Dako
Androgeacutenovyacute receptor AR Novocastra
Bcl-2 BCL2 Dako
Βetacatenin BCAT Dako
Caldesmon CDES Dako
Calretinin CRT Dako
CD10 CD10 Novocastra
CD20cy CD20 L26 Dako
CD30 CD30 Dako
CD31 CD31 Dako
CD34 Class II CD34 Dako
CD45 CD45 LCA Dako
CD45RO CD45RO UCHL1 Dako
CD56 CD56 Dako
CD68 CD68 Novocastra
CD99 CD99 Dako
CD117 CD117 Dako
CDX2 CDX2 Dako
Cytokeratiacuten 56 CK56 Dako
Cytokeratiacuten 7 CK7 Novocastra
Cytokeratiacuten 18 CK18 Dako
Cytokeratiacuten 19 CK19 Dako
Cytokeratiacuten 20 CK20 Novocastra
Cytokeratiacuten AE1AE3 AE13 Dako
Cytokeratiacuten HMW CKHMW Dako
Dezmiacuten DEZ Novocastra
EGFR EGFR Dako
E-kadheriacuten CAD Dako
Epitelovyacute membraacutenovyacute antigeacuten EMA Dako
Estrogeacutenovyacute receptor ER Novocastra
Gastrin GAST Dako
Glukagon GLUK Dako
Gross cystic disease fluid protein-15 GCDF Dako
Ľudskyacute choriogonadotropiacuten HCG Dako
Helicobacter pylori HP Dako
Hepatocyte HEP Dako
HER2 HER2 Dako
Chromograniacuten A CHROM Dako
8 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Inhibiacuten INH Novocastra
Inzuliacuten INZ Dako
Kalcitoniacuten KALC Dako
Kappa light chains IgK Dako
Karbonickaacute anhydraacuteza IX CAIX BioScience
Karcinoembryonaacutelny antigeacuten (monoklonaacutelna) CEA Dako
Ki-67 Ki-67 Novocastra
Lambda light chains IgL Dako
Mammaglobin MAM Dako
Melan A MELAN Dako
Melanozoacutem HMB45 Dako
Mismatch repair protein MLH1 MLH1 Novocastra
Mismatch repair protein MSH2 MSH2 Novocastra
Mismatch repair protein MSH6 MSH6 Dako
Mismatch repair protein PMS2 PMS2 Dako
Myogenin MG Dako
Enolaacuteza špecifickaacute pre neuroacuteny NSE Dako
OCT34 OCT34 Novocastra
Placentaacuterna alkalickaacute fosfataacuteza PLAP Novocastra
p16 p16 Santa Cruz Biotechnology
p53 p53 Novocastra
p63 p63 Dako
-metyl-CoA Racemaacuteza AMACR Dako
Progesteroacutenovyacute receptor PR Novocastra
Prostatickyacute špecifickyacute antigeacuten PSA Dako
Serotonin SRT Dako
Somatostatin SOM Dako
S-100 S-100 Dako
Synaptofyziacuten SYN Novocastra
Tyreoglobuliacuten THG Dako
Tyreoidnyacute transkripčnyacute faktor -1 TTF-1 Dako
Vimentiacuten VIM Dako
WT1 WT1 Dako
3 Priacuteloha 3 Zoznam cytochemickyacutech farbeniacute použiacutevanyacutech na UacuteP
1 Farbenie hematoxyliacutenom-eoziacutenom
2 Farbenie podľa Giemsa ndash Romanowski
3 Farbenie podľa Papanicolaoua ndash polychroacutem EA-50 (PAP)
4 Imunocytochemickeacute vyšetrenie antigeacutenu p16 a Ki67
4 Priacuteloha 4 Zoznam použitej literatuacutery
Literatuacutera použitaacute v ŠPP OKPC01
1 Rosai and Ackerman Surgical Pathology ed Juan Rosai 9 vyd Mosby Elsevier inc 2004
2 Leverrsquos Histopathology of the Skin ed David E Elder 9 vyd Lippincott WilliamsampWilkins 2005
3 Vacek Z Histologie a histologickaacute technika 1 vyd Institut pro dalšiacute vzdělaacutevaacuteniacute pracovniacuteků ve zdravotnictviacute 1996
4 Mezinaacuterodniacute klasifikace nemociacute pro onkologii 3 vyd Světovaacute zdravotnickaacute organizace 2000
5 Pathology and Genetics of Tumours of Haematopoietic and Lymphoid Tissues ed Elaine S Jaffe Nancy Lee Harris Harald Stein James W
Vardiman IARCPress 2001
6 Pathology and Genetics of Tumours of the Breast and Female Genital Organs ed Fattaneh A Tavassoli Peter Devilee IARCPress 2003
7 Pathology and Genetics of Tumours of the Digestive System ed Stanley R Hamilton Lauri A Aaltonen IARCPress 2000
8 Pathology and Genetics of Tumours of Soft Tissue and Bone ed Christopher D M Fletcher K Krishnan Unni Fredrik Mertens IARCPress 2002
9 Pathology and Genetics of Tumours of the Urinary System and Male Genital Organs ed John N Eble Guido Sauter Jonathan I Epstein Isabell A
Sesterhenn IARCPress 2004
10 Pathology and Genetics of Tumours of the Nervous System ed Paul Kleihnes Webster K Cavenee IARCPress 2000
11 Blausteinrsquos Pathology of the Female Genital Tract ed Robert J Kurman Springer-Verlag New York 2002
12 Rosen P P Rosenrsquos Breast Pathology Lippincott WilliamsampWilkins 2001
Literatuacutera použitaacute v ŠPP OKPC02
1 Čunderliacutekovaacute M Balaacutežovaacute V Vybraneacute kapitoly z histologickej techniky Vydavateľstvo Osveta 1990 s167 ISBN 80-217-0269-9
2 Vacek Z Histologie a histologickaacute technika 1 vyd Institut pro dalšiacute vzdělaacutevaacuteniacute pracovniacuteků ve zdravotnictviacute 1996
3 Susan C Lester Manual of Surgical Pathology 2 edition Elsevier Churchill Livingstone 2006
4 Bancroft JD Gamble M Theory and practice of histological techniques Churchil-Livingstone 6th edition 2008 ISBN978-0-443-10279-0 s725
5 Callis GM Bone In Bancroft JD Gamble M Theory and practice of histological techniques Churchil-Livingstone 6th edition 2008 s333 ndash
363
Literatuacutera použitaacute v ŠPP OKPC03
1 Susan C Lester Manual of Surgical Pathology 2 edition Elsevier Churchill Livingstone 2006
2 Rosai and Ackerman Surgical Pathology ed Juan Rosai 9 vyd Mosby Elsevier inc 2004
3 Leverrsquos Histopathology of the Skin ed David E Elder 9 vyd Lippincott WilliamsampWilkins 2005
4 Vacek Z Histologie a histologickaacute technika 1 vyd Institut pro dalšiacute vzdělaacutevaacuteniacute pracovniacuteků ve zdravotnictviacute 1996
5 Mezinaacuterodniacute klasifikace nemociacute pro onkologii 3 vyd Světovaacute zdravotnickaacute organizace 2000
6 Pathology and Genetics of Tumours of Haematopoietic and Lymphoid Tissues ed Elaine S Jaffe Nancy Lee Harris Harald Stein James W
Vardiman IARCPress 2001
9 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
7 Pathology and Genetics of Tumours of the Breast and Female Genital Organs ed Fattaneh ATavassoli Peter Devilee IARCPress 2003
8 Pathology and Genetics of Tumours of the Digestive System ed Stanley R Hamilton Lauri A Aaltonen IARCPress 2000
9 Pathology and Genetics of Tumours of Soft Tissue and Bone ed Christopher D M
10 Fletcher K Krishnan Unni Fredrik Mertens IARCPress 2002
11 Pathology and Genetics of Tumours of the Urinary System and Male Genital Organs ed John N Eble Guido Sauter Jonathan I Epstein Isabell A
Sesterhenn IARCPress 2004
12 Pathology and Genetics of Tumours of the Nervous System ed Paul Kleihnes Webster K Cavenee IARCPress 2000
13 Blausteinrsquos Pathology of the Female Genital Tract ed Robert J Kurman Springer-Verlag
New York 2002
14 Rosen P P Rosenrsquos Breast Pathology Lippincott WilliamsampWilkins 2001
Literatuacutera použitaacute v ŠPP OKPC04
1 Gomolčaacutek P Zaacuteklady imunohistocheacutemie v patoloacutegii IDVPZ Brno 1997 92 s ISBN 80-7013-239-6
2 Key M et al Immunohistochemical staining methods fourth edition education guide DAKO corporatio Carpinteacuteria California 2006 174 s
3 Lukaacuteš Z Draacuteberovaacute E Feit J Vojtěšek B Imunohistochemickeacute metody v biologii a v bioptickeacute diagnostice Acta facultatis medicae Universitatis
Masarykianae Brunensis Sborniacutek praciacute LF v Brně č 112 LF Masarykovy University Brno 1997 147 s ISBN 80-210-0620-X
4 Taylor CR Cote RJ Immunomicroscopy a diagnostic tool for the surgical pathologist third edition Saunders Elsevier 2006 531 s ISBN
0721601820
5 httpwwwihcworldcom
6 httpdistdakocom
7 Shi S-R Key ME Kalra KL Antigen retrieval in formalinfixed paraffin-embedded tissues an enhancement method for immunohistochemical
staining based on microwave oven heating of tissue sections J Histochem Cytochem 1991 39(6) 741-748
8 Shi S-R Cote RJ Taylor CR Antigen retrieval immunohistochemistry past present and future J Histochem Cytochem 1997 45 (3) 327-343
9 Miller RT Technical immunohistochemistry achieving reliability and reproducibility of immunostains [online] New York Society for Applied
Immunohistochemistry Annual Meeting 2001 [cit 2008-12-12] Dostupneacute na lthttpwwwihcworldcom_booksTechnical-IHCpdfgt
Literatuacutera použitaacute v ŠPP OKPC05
1 WiedGKeebler CM Koos LG Patten SFRosenthal DL Compendium on Diagnostic Cytology
2 Richard M De May The Art and Science of Cytopathology
3 Adam P Taborskyacute L Sobek O Kolbich PCytogy of cerebrospinal fluid
4 Takahashi MColor atlas of cancer cytology
Literatuacutera použitaacute v ŠPP OKPC06
1 WiedGKeebler CM Koos LG Patten SFRosenthal DL Compendium on Diagnostic Cytology
2 Richard M De May The Art and Science of Cytopathology
3 JKobilkovaacute JSirackyacute a kolCytodiagnostika v gynekologii
4 JKobilkovaacuteZLojdaJOndrušABekovaacute Gynekologickaacute cytodiagnostika
5 JKobilkovaacute Zaacuteklady cytopatoloacutegie
10 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Flexibilnyacute rozsah akreditaacutecie
Naacutezov akreditovaneacuteho subjektu Onkologickyacute uacutestav sv Alžbety sro
Heydukova 10 812 50 Bratislava
Uacutestav laboratoacuternej mediciacuteny SZU a OUacuteSA
Oddelenie lekaacuterskej genetiky
Flexibilnyacute rozsah akreditaacutecie je zverejnenyacute na adrese
httpwwwousask_imgDocumentsDocumentyZoznam_akreditovanych_cinnostipdf
Polo
žka Objekt skuacutešky Zavedenaacute metoacuteda
Ostatneacute
špecifikaacutecie Systeacutem
Biologickyacute
materiaacutel
Analyt
Ukazovateľ
Princiacutep
Druh
Typ
Označenie
1 Analyacuteza germinatiacutevnych variantov
11
Ľudskaacute
perifeacuterna krv
-Germinatiacutevne varianty v geacutene
BRCA12
Izolaacutecia DNA
PCR
amplifikaacutecia
Sekvenačnaacute
analyacuteza
ŠPP OLG1
(dolu uved orig
praacutece)
Kvalitatiacutevna skuacuteška
12 -Germinatiacutevne varianty v geacutene RET
Izolaacutecia DNA
PCR
amplifikaacutecia
Sekvenačnaacute
analyacuteza
ŠPP OLG2
(dolu uved orig
praacutece)
13 - - Docirckaz germinatiacutevnych variantov v
geacutene MLH1 a MSH2
Izolaacutecia DNA
PCR
amplifikaacutecia
Sekvenačnaacute
analyacuteza
ŠPP OLG10
(dolu uved orig
praacutece)
14 - - Docirckaz germinatiacutevnych variantov
v geacutene VHL
Izolaacutecia DNA
PCR
amplifikaacutecia
Sekvenačnaacute
analyacuteza
SPP OLG14
(dolu uvedeneacute
origpraacutece)
15
- - Docirckaz germinatiacutevnych variantov
v paneli geacutenov asociovanyacutech
s onkologickyacutemi hereditaacuternymi
syndroacutemami
Izolaacutecia DNA
PCR
amplifikaacutecia
Sekvenačnaacute
analyacuteza
SPP OLG15
(dolu uvedeneacute
origpraacutece)
2 Analyacuteza somatickyacutech variantov
21
Fixovaneacute
natiacutevne tkanivo
- Docirckaz somatickyacutech variantov
v exoacutenoch 2 3 a 4 geacutenu KRAS a
NRAS pri naacutedoroch kolorekta
Izolaacutecia DNA
PCR
amplifikaacutecia
Mini-sekvenačnaacute
analyacuteza
Real-Time PCR
ŠPP OLG5
(dolu uved orig
praacutece)
Kvalitatiacutevna skuacuteška 22
- Docirckaz somatickyacutech variantov
v kodoacutene 600 geacutenu BRAF pri
naacutedoroch štiacutetnej žľazy a maliacutegnom
melanoacuteme
Izolaacutecia DNA
PCR
amplifikaacutecia
Mini-sekvenačnaacute
analyacuteza
Real-Time PCR
ŠPP OLG9
(dolu uved orig
praacutece)
ŠPP OLG5
(dolu uved orig
praacutece)
23
Fixovaneacute
natiacutevne
tkanivocytologi
ckeacute stery
- Docirckaz somatickyacutech variantov
v exoacutenoch 18 19 20 a 21 geacutenu
EGFR pri nemalobunkovom
karcinoacuteme pľuacutec
Izolaacutecia DNA
PCR
amplifikaacutecia
Mini-sekvenačnaacute
analyacuteza
Real-Time PCR
ŠPP OLG11
(dolu uved orig
praacutece)
ŠPP OLG5
(dolu uved orig
praacutece)
11 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Polo
žka Objekt skuacutešky Zavedenaacute metoacuteda
Ostatneacute
špecifikaacutecie Systeacutem
Biologickyacute
materiaacutel
Analyt
Ukazovateľ
Princiacutep
Druh
Typ
Označenie
24 Fixovaneacute
natiacutevne tkanivo
-Docirckaz somatickyacutech variantov
v geacutene BRCA12
Izolaacutecia DNA
PCR
amplifikaacutecia
Sekvenačnaacute
analyacuteza
Mini-skevenačnaacute
analyacuteza
ŠPP OLG16
(dolu uved orig
praacutece)
Kvalitatiacutevna skuacuteška
4 Genotypizaacutecia ľudskyacutech papilomaviacuterusov
41
Bunkovaacute
suzpenzia
fixovaneacute
tkanivo
perifeacuterna krv
-Genotypizaacutecia HPV
Izolaacutecia DNA
PCR
amplifikaacutecia
Real-Time PCR
ŠPP OLG3
(dolu uved orig
praacutece)
Kvalitatiacutevna skuacuteška
5 Docirckaz priacutetomnosti HPV
51 Bunkovaacute
suzpenzia -Docirckaz priacutetomnosti HPV
Izolaacutecia DNA
Real-Time PCR
ŠPP OLG13
(dolu uved orig
praacutece)
Kvalitatiacutevna skuacuteška
6 Docirckaz veľkyacutech geacutenovyacutech prestavieb v geacutenoch asociovanyacutech s onkologickyacutemi hereditaacuternymi syndroacutemami metoacutedou MLPA
61
Ľudskaacute
perifeacuterna krv
Fixovaneacute
natiacutevne tkanivo
- - Docirckaz veľkyacutech geacutenovyacutech
prestavieb v geacutenoch asociovanyacutech s
onkologickyacutemi hereditaacuternymi
syndroacutemami metoacutedou MLPA
Izolaacutecia DNA
PCR
amplifikaacutecia
Fragmentačnaacute
analyacuteza
SPP OLG17
(dolu uvedeneacute
origpraacutece)
Kvalitatiacutevna skuacuteška
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG1
1 Friedman L Ostermeyer E A Szabo CI a kol Confirmation of BRCA1 by analysis of germline mutations linked to breast and ovarian cancer in
ten families Nat Genetics 8 399-404 1994
2 Miki Y Katagiri T Kasumi F a kol Mutation analysis in the BRCA2 gene in primary breast cancer Nat Genetics 2 245-7 1996
3 Wagner T M U Hirtenlehner K Shen P a kol Global sequence diversity of BRCA2 analysis of 71 breast cancer families and 95 control
individuals of worldwilde populatins Hum Mol Genetocs Vol 8 No 3 1999
4 QIAamp DNA Mini Kit and OIAamp DNA Blood Mini Kit Handbook
5 Nanodrop ND 1000 useracutes manual
6 Promega Protocols and applications guide The Source for Discovery PCR cheapter Promega Corporation USA 1996
7 Amersham Pharmacia Biotech DNA Silver Staining Kit instructions
8 BigDye Terminator v 11 Cycle Sequencing Kit Protokol Applied Biosystems
9 Applied Biosystems DNA Sequencing Analysis Software Version 51 for Windows XP and 2000 Platforms User Guide Applied Biosystems
10 Applied Biosystems 31303130xl Genetic Analyzers Getting Started Guide Applied Biosystems
11 Konecny M et al Comprehensive genetic characterization of hereditary breastovarian cancer families from Slovakia Breast Cancer Res Treat
(2011) 126119ndash130
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG2
1 Ceccherini I Hofstra RMW Luo Y a kol DNA polymorphisms and conditions for SSCP analysis of the 20 exons of the RET proto-oncogene
Oncogene 9 3025-3029 1994
2 De Groot et al RET as a dignostic and therapeutic target in sporadic and hereditary endocrine tumors 2006 Endocrine Reviews 27(5) 535-560
3 Martucciello G Lerone M et al Multiple endocrine neoplasias type 2B and RET proto-oncogene Ital J Pediatr 2012 Mar 19389 doi
1011861824-7288-38-9 Review
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG3
1 Weismanovaacute E Weismann P Vizvaacuteryovaacute M a kol New approach to human high-risk papillomavirus (HR-HPV) genotyping Neoplasma 49
217-224 2002
2 Amersham Biosciences GenomicPrep Cells and Tissue DNA Isolation Kit instructions
3 Amersham Pharmacia Biotech QuickPrep Total RNA Extraction Kit instructions
4 Amersham Pharmacia Biotech Ready To Go You-Prime First-Strand Beads instructions
5 Amersham Pharmacia Biotech Ready To Go PCR Beads instructions
6 Amersham Pharmacia Biotech DNA Silver Staining Kit instructions
7 F-HPV typingTM Kit Manual
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG5
1 Van Krieken J H J M Jung A Kirchner T a kol KRAS mutation testing for predicting response to anti-EGFR therapy for colorectal carcinoma
proposal for an European quality assurance program Virchows Arch (2008) 453417-431
2 Lievre A Bachet J Le Corre D a kol KRAS mutation status is predictive of response to cetuximab therapy in colorectal cancer Cancer Res
(2006) 668
3 TheraScreen K-RAS Mutation Manual
4 BigDye Terminator v 11 Cycle Sequencing Kit Protokol Applied Biosystems
5 Applied Biosystems DNA Sequencing Analysis Software Version 51 for Windows XP and 2000 Platforms User Guide Applied Biosystems
6 Applied Biosystems 3500 Genetic Analyzers Getting Started Guide Applied Biosystems
8 SNaPshot Multiplex Kit ndash protocol and manual
12 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG9 1 Nikiforov YE thyroid carcinoma molecular pathways and therapeutic targets Modern pathology 21S37-S43 2008
2 Elisei R Ugolini C Viola D Lupi C et al BRAF V600E mutation and outcome of patients with papillary thyroid carcinoma
A 15-year median follow-up study J Clin endocrine Metab 93(10)3943-3949 2008
3 SNaPshot Multiplex Kit ndash protocol and manual Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG10
1 Brigitte Wolf Silvia Henglmueller at al Spectrum of germ-line MLH1 and MSH2 mutations in Austrian patientswith hereditary nonpolyposis
colorectal cancer The Middle European Journal of Medicine 2005 1177ndash8 269ndash277
2 Elisabeth mangold Constanze Pagenstecher et al Spectrum and frequencies of mutations in MSH2 and MLH1 identified in 1721 german families
suspected of hereditary nonpolyposis colorectal cancer Int J Cancer 2005 116 692-702
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG11
1 Rosell R Moran T Queralt C Porta R Cardenal F Camps C Majem M Lopez-Vivanco G Isla D Provencio M Insa A Massuti
B Gonzalez-Larriba J L Paz-Ares L Bover I Garcia-Campelo R Moreno M A Catot S Rolfo C Reguart N Palmero R Sanchez
JM Bastus R Mayo C Bertran- Alamillo J Molina M A Sanchez J J Taron M (2009) Screening for epidermal growth factor receptor
mutations in lung cancer N Engl J Med 361 958-967
2 Peacuterez-Soler R Chachoua A Hammond L A Rowinsky E K Huberman M Karp M Rigas J Clark G M Santabaacuterbara P Bonomi P
(2004) Determinants of Tumor Response and Survival With Erlotinib in Patients With NonndashSmall-Cell Lung Cancer Journal og Clinical
Oncology 22 16
3 Pines G Koumlstler W JYosef Yarden Department of Biological Regulation The Weizmann Institute of Science Rehovot 76100 Israel (2010)
Oncogenic mutant forms of EGFR lessons in signal transduction and targets for cancer therapy FEBSLett 584 (12) 2699ndash2706
4 ABI PRISM SnaPshot Multiplex Kit ndashProtocol and manual
5 cobasreg EGFR Mutation Test ndash User Manual
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG13
1 cobasreg 4800 HPV Test ndash Dokument č 05990343001-04SK Roche Diagnostics GmbH
2cobasreg 4800 HPV Test ndash Dokument č 05641268001-01 Roche Molecular Systems Inc
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG14
1 Nielsen SM Rhodes L Blanco I a kol 2016 Von Hippel-Lindau Disease Genetics and Role of Genetic Counseling in a Multiple Neoplasia
Syndrome J Clin Oncol 34(18)2172-2181
2 Alberta Health Services 2011 Renal cell carcinoma and genetic testing Clinical Practice Guideline GU-005
3 Chittiboina P Lonser RR 2015 Von Hippel-Lindau disease Handb Clin Neurol132139-156
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG15
1 Hereditary Cancer Solution by Sophia Genetics ndash Users guide using DNA library prep kit by Sophia genetics 48 samples
2 BRCA Hereditary Cancer MASTR Plus kit with drMID for Ilumina NGS systems ndash instructions for use
3 Crawford B Adams S B Sittler et al (2017) Multi-gene panel testing for hereditary cancer predisposition in unsolved high-risk breast and ovarian
cancer patients Breast cancer research and treatment 163(2) 383-390
4 Grissom A A Friend P J (2016) Multigene Panel Testing for Hereditary Cancer Risk Journal of the advanced practitioner in oncology 7(4) 394-
407
5 Lorans M Dow E Macrae FA Winship IM Buchanan DD (2018) Update on Hereditary Colorectal Cancer Improving the Clinical Utility of
Multigene Panel Testing Clin Colorectal Cancer 17(2)e293-e305
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG16
1 Ledermann PARP inhibitors in ovarian cancer Annals of Oncology (2016) 27 i40ndashi44
2 Koczkowska M et al Detection of somatic BRCA12 mutations in ovarian cancer - next-generation sequencing analysis of 100 cases Cancer Med
2016 Jul5(7)1640-6
3 Dougherty BA et al Biological and clinical evidence for somatic mutations in BRCA1 and BRCA2 as predictive markers for olaparib response in
high-grade serous ovarian cancers in the maintenance setting Oncotarget 2017 Jul 48(27)43653-43661
4 Maxwell KN et al BRCA locus-specific loss of heterozygosity in germline BRCA1 and BRCA2 carriers Nat Commun 2017 Aug 228(1)319
5 httpswwwagilentcomcslibrarybrochuresBrochure20Complete20solution20BRCA20MASTR20(Plus)20Dx20v1708pdf
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG17
1 MRC-Holland ndash MLPA General Protocol httpswwwmlpacom
2 Ticha I Kleibl Z Stribrna J a kol Screening for genomic rearragements in a genes in Czech high-risk breastovarian cancer patients high
proportion of population specific alterations in gene Breast Cancer Research and Treatment 2010 124 (2)337-347
3 Sluiter MD van Rensburg EJ Large genomic rearragements of the BRCA1 and BRCA2 genes review of the literature and report of a novel BRCA1
mutation Breast Cancer Research and Treatment 2011 125 325-349
Osoby spocircsobileacute modifikovať a validovať metoacutedy na Oddeleniacute lekaacuterskej genetiky
Meno a priezvisko tituly Spocircsobilosť modifikovať a validovať metoacutedy
ndash čiacuteslo položky v rozsahu akreditaacutecie
Regiacutena Lohajovaacute Behulovaacute RNDr PhD 11 až 61
Katariacutena Zaacutevodnaacute RNDr PhD 11 až 61
Ľudmila Vavrovaacute Ing PhD 11 až 61
Tomaacuteš Slamka Mgr 11 až 61
Lukaacuteš Šebest Mgr PhD 11 až 61
Aster Alemayehu RNDr PhD 11 až 61
13 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Použiteacute skratky
AGLUT ndash aglutinačnaacute reakcia
AOD ndash askorbaacutetoxidaacuteza
BRCA ndash označenie geacutenu asociovaneacuteho s dedičnou formou mamaacuternehoovariaacutelneho karcinoacutemu
CDKN2A ndash označenie geacutenu asociovaneacuteho s dedičnou formou maliacutegneho melanoacutemu
E6E7 - HPV viacuterusoveacute onkogeacuteny asociovaneacute so vznikom a progresiou Ca krčka maternice
FOTO - fotometria
GLD ndash glutamaacutetdehydrogenaacuteza
GPO ndash glycerol-3-fosfaacutet-oxidaacuteza
HPLC ndash High Performance Liquid Chromatography
HPV ndash human papillomavirus (ľudskyacute papilloma viacuterus)
CHOD ndash cholesteroloxidaacuteza
IFCC ndash International Federation for Clinical Chemistry
IMF ndash meranie fluorescencie po značeniacute buniek protilaacutetkami
KOAG ndash Coagulation Point Detection Method
KRAS ndash označenie geacutenu kt somatickeacute mutaacutecie v suacute predikatiacutevnym markerom pri metastazujuacutecom ca hrubeacuteho čreva
LATEX ndash Latex immunoassay method
MLH1 - označenie geacutenu asociovaneacuteho s dedičnou formou kolorektaacutelneho karcinoacutemu
MSH2 - označenie geacutenu asociovaneacuteho s dedičnou formou kolorektaacutelneho karcinoacutemu
NRAS ndash označenie geacutenu kt somatickeacute mutaacutecie v suacute predikatiacutevnym markerom pri metastazujuacutecom ca hrubeacuteho čreva
OHT - Oddelenie hematoloacutegie a transfuzioloacutegie
OID ndash Oddelenie imunodiagnostiky
OKB ndash Oddelenie klinickej biocheacutemie
OKIA - Oddelenie klinickej imunoloacutegie a alergoloacutegie
OKPC - Oddelenie klinickej patoloacutegie a cytoloacutegie
OLG ndash Oddelenie lekaacuterskej genetiky
PAP ndash peroxidaacuteza
PCR ndash polymeraacutezovaacute reťazovaacute reakcia
PHOTO ndash spektrofotometrickaacute metoacuteda
PLP ndash pyridoxalfosfaacutet
POD ndash peroxidaacuteza
RET ndash označenie geacutenu v dedičnej forme medulaacuterneho karcinoacutemu a syndroacutemu mnohopočetnej endokrinnej neoplaacutezie typu 2
RIA - Radio Immunoassay
RT - Real-Time
ŠPP ndash Štandardnyacute pracovnyacute postup
TPO ndash Tyreoidaacutelna peroxidaacuteza
TRACE ndash Time Resolved Amplified Cryptate Emission
8 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Inhibiacuten INH Novocastra
Inzuliacuten INZ Dako
Kalcitoniacuten KALC Dako
Kappa light chains IgK Dako
Karbonickaacute anhydraacuteza IX CAIX BioScience
Karcinoembryonaacutelny antigeacuten (monoklonaacutelna) CEA Dako
Ki-67 Ki-67 Novocastra
Lambda light chains IgL Dako
Mammaglobin MAM Dako
Melan A MELAN Dako
Melanozoacutem HMB45 Dako
Mismatch repair protein MLH1 MLH1 Novocastra
Mismatch repair protein MSH2 MSH2 Novocastra
Mismatch repair protein MSH6 MSH6 Dako
Mismatch repair protein PMS2 PMS2 Dako
Myogenin MG Dako
Enolaacuteza špecifickaacute pre neuroacuteny NSE Dako
OCT34 OCT34 Novocastra
Placentaacuterna alkalickaacute fosfataacuteza PLAP Novocastra
p16 p16 Santa Cruz Biotechnology
p53 p53 Novocastra
p63 p63 Dako
-metyl-CoA Racemaacuteza AMACR Dako
Progesteroacutenovyacute receptor PR Novocastra
Prostatickyacute špecifickyacute antigeacuten PSA Dako
Serotonin SRT Dako
Somatostatin SOM Dako
S-100 S-100 Dako
Synaptofyziacuten SYN Novocastra
Tyreoglobuliacuten THG Dako
Tyreoidnyacute transkripčnyacute faktor -1 TTF-1 Dako
Vimentiacuten VIM Dako
WT1 WT1 Dako
3 Priacuteloha 3 Zoznam cytochemickyacutech farbeniacute použiacutevanyacutech na UacuteP
1 Farbenie hematoxyliacutenom-eoziacutenom
2 Farbenie podľa Giemsa ndash Romanowski
3 Farbenie podľa Papanicolaoua ndash polychroacutem EA-50 (PAP)
4 Imunocytochemickeacute vyšetrenie antigeacutenu p16 a Ki67
4 Priacuteloha 4 Zoznam použitej literatuacutery
Literatuacutera použitaacute v ŠPP OKPC01
1 Rosai and Ackerman Surgical Pathology ed Juan Rosai 9 vyd Mosby Elsevier inc 2004
2 Leverrsquos Histopathology of the Skin ed David E Elder 9 vyd Lippincott WilliamsampWilkins 2005
3 Vacek Z Histologie a histologickaacute technika 1 vyd Institut pro dalšiacute vzdělaacutevaacuteniacute pracovniacuteků ve zdravotnictviacute 1996
4 Mezinaacuterodniacute klasifikace nemociacute pro onkologii 3 vyd Světovaacute zdravotnickaacute organizace 2000
5 Pathology and Genetics of Tumours of Haematopoietic and Lymphoid Tissues ed Elaine S Jaffe Nancy Lee Harris Harald Stein James W
Vardiman IARCPress 2001
6 Pathology and Genetics of Tumours of the Breast and Female Genital Organs ed Fattaneh A Tavassoli Peter Devilee IARCPress 2003
7 Pathology and Genetics of Tumours of the Digestive System ed Stanley R Hamilton Lauri A Aaltonen IARCPress 2000
8 Pathology and Genetics of Tumours of Soft Tissue and Bone ed Christopher D M Fletcher K Krishnan Unni Fredrik Mertens IARCPress 2002
9 Pathology and Genetics of Tumours of the Urinary System and Male Genital Organs ed John N Eble Guido Sauter Jonathan I Epstein Isabell A
Sesterhenn IARCPress 2004
10 Pathology and Genetics of Tumours of the Nervous System ed Paul Kleihnes Webster K Cavenee IARCPress 2000
11 Blausteinrsquos Pathology of the Female Genital Tract ed Robert J Kurman Springer-Verlag New York 2002
12 Rosen P P Rosenrsquos Breast Pathology Lippincott WilliamsampWilkins 2001
Literatuacutera použitaacute v ŠPP OKPC02
1 Čunderliacutekovaacute M Balaacutežovaacute V Vybraneacute kapitoly z histologickej techniky Vydavateľstvo Osveta 1990 s167 ISBN 80-217-0269-9
2 Vacek Z Histologie a histologickaacute technika 1 vyd Institut pro dalšiacute vzdělaacutevaacuteniacute pracovniacuteků ve zdravotnictviacute 1996
3 Susan C Lester Manual of Surgical Pathology 2 edition Elsevier Churchill Livingstone 2006
4 Bancroft JD Gamble M Theory and practice of histological techniques Churchil-Livingstone 6th edition 2008 ISBN978-0-443-10279-0 s725
5 Callis GM Bone In Bancroft JD Gamble M Theory and practice of histological techniques Churchil-Livingstone 6th edition 2008 s333 ndash
363
Literatuacutera použitaacute v ŠPP OKPC03
1 Susan C Lester Manual of Surgical Pathology 2 edition Elsevier Churchill Livingstone 2006
2 Rosai and Ackerman Surgical Pathology ed Juan Rosai 9 vyd Mosby Elsevier inc 2004
3 Leverrsquos Histopathology of the Skin ed David E Elder 9 vyd Lippincott WilliamsampWilkins 2005
4 Vacek Z Histologie a histologickaacute technika 1 vyd Institut pro dalšiacute vzdělaacutevaacuteniacute pracovniacuteků ve zdravotnictviacute 1996
5 Mezinaacuterodniacute klasifikace nemociacute pro onkologii 3 vyd Světovaacute zdravotnickaacute organizace 2000
6 Pathology and Genetics of Tumours of Haematopoietic and Lymphoid Tissues ed Elaine S Jaffe Nancy Lee Harris Harald Stein James W
Vardiman IARCPress 2001
9 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
7 Pathology and Genetics of Tumours of the Breast and Female Genital Organs ed Fattaneh ATavassoli Peter Devilee IARCPress 2003
8 Pathology and Genetics of Tumours of the Digestive System ed Stanley R Hamilton Lauri A Aaltonen IARCPress 2000
9 Pathology and Genetics of Tumours of Soft Tissue and Bone ed Christopher D M
10 Fletcher K Krishnan Unni Fredrik Mertens IARCPress 2002
11 Pathology and Genetics of Tumours of the Urinary System and Male Genital Organs ed John N Eble Guido Sauter Jonathan I Epstein Isabell A
Sesterhenn IARCPress 2004
12 Pathology and Genetics of Tumours of the Nervous System ed Paul Kleihnes Webster K Cavenee IARCPress 2000
13 Blausteinrsquos Pathology of the Female Genital Tract ed Robert J Kurman Springer-Verlag
New York 2002
14 Rosen P P Rosenrsquos Breast Pathology Lippincott WilliamsampWilkins 2001
Literatuacutera použitaacute v ŠPP OKPC04
1 Gomolčaacutek P Zaacuteklady imunohistocheacutemie v patoloacutegii IDVPZ Brno 1997 92 s ISBN 80-7013-239-6
2 Key M et al Immunohistochemical staining methods fourth edition education guide DAKO corporatio Carpinteacuteria California 2006 174 s
3 Lukaacuteš Z Draacuteberovaacute E Feit J Vojtěšek B Imunohistochemickeacute metody v biologii a v bioptickeacute diagnostice Acta facultatis medicae Universitatis
Masarykianae Brunensis Sborniacutek praciacute LF v Brně č 112 LF Masarykovy University Brno 1997 147 s ISBN 80-210-0620-X
4 Taylor CR Cote RJ Immunomicroscopy a diagnostic tool for the surgical pathologist third edition Saunders Elsevier 2006 531 s ISBN
0721601820
5 httpwwwihcworldcom
6 httpdistdakocom
7 Shi S-R Key ME Kalra KL Antigen retrieval in formalinfixed paraffin-embedded tissues an enhancement method for immunohistochemical
staining based on microwave oven heating of tissue sections J Histochem Cytochem 1991 39(6) 741-748
8 Shi S-R Cote RJ Taylor CR Antigen retrieval immunohistochemistry past present and future J Histochem Cytochem 1997 45 (3) 327-343
9 Miller RT Technical immunohistochemistry achieving reliability and reproducibility of immunostains [online] New York Society for Applied
Immunohistochemistry Annual Meeting 2001 [cit 2008-12-12] Dostupneacute na lthttpwwwihcworldcom_booksTechnical-IHCpdfgt
Literatuacutera použitaacute v ŠPP OKPC05
1 WiedGKeebler CM Koos LG Patten SFRosenthal DL Compendium on Diagnostic Cytology
2 Richard M De May The Art and Science of Cytopathology
3 Adam P Taborskyacute L Sobek O Kolbich PCytogy of cerebrospinal fluid
4 Takahashi MColor atlas of cancer cytology
Literatuacutera použitaacute v ŠPP OKPC06
1 WiedGKeebler CM Koos LG Patten SFRosenthal DL Compendium on Diagnostic Cytology
2 Richard M De May The Art and Science of Cytopathology
3 JKobilkovaacute JSirackyacute a kolCytodiagnostika v gynekologii
4 JKobilkovaacuteZLojdaJOndrušABekovaacute Gynekologickaacute cytodiagnostika
5 JKobilkovaacute Zaacuteklady cytopatoloacutegie
10 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Flexibilnyacute rozsah akreditaacutecie
Naacutezov akreditovaneacuteho subjektu Onkologickyacute uacutestav sv Alžbety sro
Heydukova 10 812 50 Bratislava
Uacutestav laboratoacuternej mediciacuteny SZU a OUacuteSA
Oddelenie lekaacuterskej genetiky
Flexibilnyacute rozsah akreditaacutecie je zverejnenyacute na adrese
httpwwwousask_imgDocumentsDocumentyZoznam_akreditovanych_cinnostipdf
Polo
žka Objekt skuacutešky Zavedenaacute metoacuteda
Ostatneacute
špecifikaacutecie Systeacutem
Biologickyacute
materiaacutel
Analyt
Ukazovateľ
Princiacutep
Druh
Typ
Označenie
1 Analyacuteza germinatiacutevnych variantov
11
Ľudskaacute
perifeacuterna krv
-Germinatiacutevne varianty v geacutene
BRCA12
Izolaacutecia DNA
PCR
amplifikaacutecia
Sekvenačnaacute
analyacuteza
ŠPP OLG1
(dolu uved orig
praacutece)
Kvalitatiacutevna skuacuteška
12 -Germinatiacutevne varianty v geacutene RET
Izolaacutecia DNA
PCR
amplifikaacutecia
Sekvenačnaacute
analyacuteza
ŠPP OLG2
(dolu uved orig
praacutece)
13 - - Docirckaz germinatiacutevnych variantov v
geacutene MLH1 a MSH2
Izolaacutecia DNA
PCR
amplifikaacutecia
Sekvenačnaacute
analyacuteza
ŠPP OLG10
(dolu uved orig
praacutece)
14 - - Docirckaz germinatiacutevnych variantov
v geacutene VHL
Izolaacutecia DNA
PCR
amplifikaacutecia
Sekvenačnaacute
analyacuteza
SPP OLG14
(dolu uvedeneacute
origpraacutece)
15
- - Docirckaz germinatiacutevnych variantov
v paneli geacutenov asociovanyacutech
s onkologickyacutemi hereditaacuternymi
syndroacutemami
Izolaacutecia DNA
PCR
amplifikaacutecia
Sekvenačnaacute
analyacuteza
SPP OLG15
(dolu uvedeneacute
origpraacutece)
2 Analyacuteza somatickyacutech variantov
21
Fixovaneacute
natiacutevne tkanivo
- Docirckaz somatickyacutech variantov
v exoacutenoch 2 3 a 4 geacutenu KRAS a
NRAS pri naacutedoroch kolorekta
Izolaacutecia DNA
PCR
amplifikaacutecia
Mini-sekvenačnaacute
analyacuteza
Real-Time PCR
ŠPP OLG5
(dolu uved orig
praacutece)
Kvalitatiacutevna skuacuteška 22
- Docirckaz somatickyacutech variantov
v kodoacutene 600 geacutenu BRAF pri
naacutedoroch štiacutetnej žľazy a maliacutegnom
melanoacuteme
Izolaacutecia DNA
PCR
amplifikaacutecia
Mini-sekvenačnaacute
analyacuteza
Real-Time PCR
ŠPP OLG9
(dolu uved orig
praacutece)
ŠPP OLG5
(dolu uved orig
praacutece)
23
Fixovaneacute
natiacutevne
tkanivocytologi
ckeacute stery
- Docirckaz somatickyacutech variantov
v exoacutenoch 18 19 20 a 21 geacutenu
EGFR pri nemalobunkovom
karcinoacuteme pľuacutec
Izolaacutecia DNA
PCR
amplifikaacutecia
Mini-sekvenačnaacute
analyacuteza
Real-Time PCR
ŠPP OLG11
(dolu uved orig
praacutece)
ŠPP OLG5
(dolu uved orig
praacutece)
11 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Polo
žka Objekt skuacutešky Zavedenaacute metoacuteda
Ostatneacute
špecifikaacutecie Systeacutem
Biologickyacute
materiaacutel
Analyt
Ukazovateľ
Princiacutep
Druh
Typ
Označenie
24 Fixovaneacute
natiacutevne tkanivo
-Docirckaz somatickyacutech variantov
v geacutene BRCA12
Izolaacutecia DNA
PCR
amplifikaacutecia
Sekvenačnaacute
analyacuteza
Mini-skevenačnaacute
analyacuteza
ŠPP OLG16
(dolu uved orig
praacutece)
Kvalitatiacutevna skuacuteška
4 Genotypizaacutecia ľudskyacutech papilomaviacuterusov
41
Bunkovaacute
suzpenzia
fixovaneacute
tkanivo
perifeacuterna krv
-Genotypizaacutecia HPV
Izolaacutecia DNA
PCR
amplifikaacutecia
Real-Time PCR
ŠPP OLG3
(dolu uved orig
praacutece)
Kvalitatiacutevna skuacuteška
5 Docirckaz priacutetomnosti HPV
51 Bunkovaacute
suzpenzia -Docirckaz priacutetomnosti HPV
Izolaacutecia DNA
Real-Time PCR
ŠPP OLG13
(dolu uved orig
praacutece)
Kvalitatiacutevna skuacuteška
6 Docirckaz veľkyacutech geacutenovyacutech prestavieb v geacutenoch asociovanyacutech s onkologickyacutemi hereditaacuternymi syndroacutemami metoacutedou MLPA
61
Ľudskaacute
perifeacuterna krv
Fixovaneacute
natiacutevne tkanivo
- - Docirckaz veľkyacutech geacutenovyacutech
prestavieb v geacutenoch asociovanyacutech s
onkologickyacutemi hereditaacuternymi
syndroacutemami metoacutedou MLPA
Izolaacutecia DNA
PCR
amplifikaacutecia
Fragmentačnaacute
analyacuteza
SPP OLG17
(dolu uvedeneacute
origpraacutece)
Kvalitatiacutevna skuacuteška
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG1
1 Friedman L Ostermeyer E A Szabo CI a kol Confirmation of BRCA1 by analysis of germline mutations linked to breast and ovarian cancer in
ten families Nat Genetics 8 399-404 1994
2 Miki Y Katagiri T Kasumi F a kol Mutation analysis in the BRCA2 gene in primary breast cancer Nat Genetics 2 245-7 1996
3 Wagner T M U Hirtenlehner K Shen P a kol Global sequence diversity of BRCA2 analysis of 71 breast cancer families and 95 control
individuals of worldwilde populatins Hum Mol Genetocs Vol 8 No 3 1999
4 QIAamp DNA Mini Kit and OIAamp DNA Blood Mini Kit Handbook
5 Nanodrop ND 1000 useracutes manual
6 Promega Protocols and applications guide The Source for Discovery PCR cheapter Promega Corporation USA 1996
7 Amersham Pharmacia Biotech DNA Silver Staining Kit instructions
8 BigDye Terminator v 11 Cycle Sequencing Kit Protokol Applied Biosystems
9 Applied Biosystems DNA Sequencing Analysis Software Version 51 for Windows XP and 2000 Platforms User Guide Applied Biosystems
10 Applied Biosystems 31303130xl Genetic Analyzers Getting Started Guide Applied Biosystems
11 Konecny M et al Comprehensive genetic characterization of hereditary breastovarian cancer families from Slovakia Breast Cancer Res Treat
(2011) 126119ndash130
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG2
1 Ceccherini I Hofstra RMW Luo Y a kol DNA polymorphisms and conditions for SSCP analysis of the 20 exons of the RET proto-oncogene
Oncogene 9 3025-3029 1994
2 De Groot et al RET as a dignostic and therapeutic target in sporadic and hereditary endocrine tumors 2006 Endocrine Reviews 27(5) 535-560
3 Martucciello G Lerone M et al Multiple endocrine neoplasias type 2B and RET proto-oncogene Ital J Pediatr 2012 Mar 19389 doi
1011861824-7288-38-9 Review
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG3
1 Weismanovaacute E Weismann P Vizvaacuteryovaacute M a kol New approach to human high-risk papillomavirus (HR-HPV) genotyping Neoplasma 49
217-224 2002
2 Amersham Biosciences GenomicPrep Cells and Tissue DNA Isolation Kit instructions
3 Amersham Pharmacia Biotech QuickPrep Total RNA Extraction Kit instructions
4 Amersham Pharmacia Biotech Ready To Go You-Prime First-Strand Beads instructions
5 Amersham Pharmacia Biotech Ready To Go PCR Beads instructions
6 Amersham Pharmacia Biotech DNA Silver Staining Kit instructions
7 F-HPV typingTM Kit Manual
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG5
1 Van Krieken J H J M Jung A Kirchner T a kol KRAS mutation testing for predicting response to anti-EGFR therapy for colorectal carcinoma
proposal for an European quality assurance program Virchows Arch (2008) 453417-431
2 Lievre A Bachet J Le Corre D a kol KRAS mutation status is predictive of response to cetuximab therapy in colorectal cancer Cancer Res
(2006) 668
3 TheraScreen K-RAS Mutation Manual
4 BigDye Terminator v 11 Cycle Sequencing Kit Protokol Applied Biosystems
5 Applied Biosystems DNA Sequencing Analysis Software Version 51 for Windows XP and 2000 Platforms User Guide Applied Biosystems
6 Applied Biosystems 3500 Genetic Analyzers Getting Started Guide Applied Biosystems
8 SNaPshot Multiplex Kit ndash protocol and manual
12 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG9 1 Nikiforov YE thyroid carcinoma molecular pathways and therapeutic targets Modern pathology 21S37-S43 2008
2 Elisei R Ugolini C Viola D Lupi C et al BRAF V600E mutation and outcome of patients with papillary thyroid carcinoma
A 15-year median follow-up study J Clin endocrine Metab 93(10)3943-3949 2008
3 SNaPshot Multiplex Kit ndash protocol and manual Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG10
1 Brigitte Wolf Silvia Henglmueller at al Spectrum of germ-line MLH1 and MSH2 mutations in Austrian patientswith hereditary nonpolyposis
colorectal cancer The Middle European Journal of Medicine 2005 1177ndash8 269ndash277
2 Elisabeth mangold Constanze Pagenstecher et al Spectrum and frequencies of mutations in MSH2 and MLH1 identified in 1721 german families
suspected of hereditary nonpolyposis colorectal cancer Int J Cancer 2005 116 692-702
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG11
1 Rosell R Moran T Queralt C Porta R Cardenal F Camps C Majem M Lopez-Vivanco G Isla D Provencio M Insa A Massuti
B Gonzalez-Larriba J L Paz-Ares L Bover I Garcia-Campelo R Moreno M A Catot S Rolfo C Reguart N Palmero R Sanchez
JM Bastus R Mayo C Bertran- Alamillo J Molina M A Sanchez J J Taron M (2009) Screening for epidermal growth factor receptor
mutations in lung cancer N Engl J Med 361 958-967
2 Peacuterez-Soler R Chachoua A Hammond L A Rowinsky E K Huberman M Karp M Rigas J Clark G M Santabaacuterbara P Bonomi P
(2004) Determinants of Tumor Response and Survival With Erlotinib in Patients With NonndashSmall-Cell Lung Cancer Journal og Clinical
Oncology 22 16
3 Pines G Koumlstler W JYosef Yarden Department of Biological Regulation The Weizmann Institute of Science Rehovot 76100 Israel (2010)
Oncogenic mutant forms of EGFR lessons in signal transduction and targets for cancer therapy FEBSLett 584 (12) 2699ndash2706
4 ABI PRISM SnaPshot Multiplex Kit ndashProtocol and manual
5 cobasreg EGFR Mutation Test ndash User Manual
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG13
1 cobasreg 4800 HPV Test ndash Dokument č 05990343001-04SK Roche Diagnostics GmbH
2cobasreg 4800 HPV Test ndash Dokument č 05641268001-01 Roche Molecular Systems Inc
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG14
1 Nielsen SM Rhodes L Blanco I a kol 2016 Von Hippel-Lindau Disease Genetics and Role of Genetic Counseling in a Multiple Neoplasia
Syndrome J Clin Oncol 34(18)2172-2181
2 Alberta Health Services 2011 Renal cell carcinoma and genetic testing Clinical Practice Guideline GU-005
3 Chittiboina P Lonser RR 2015 Von Hippel-Lindau disease Handb Clin Neurol132139-156
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG15
1 Hereditary Cancer Solution by Sophia Genetics ndash Users guide using DNA library prep kit by Sophia genetics 48 samples
2 BRCA Hereditary Cancer MASTR Plus kit with drMID for Ilumina NGS systems ndash instructions for use
3 Crawford B Adams S B Sittler et al (2017) Multi-gene panel testing for hereditary cancer predisposition in unsolved high-risk breast and ovarian
cancer patients Breast cancer research and treatment 163(2) 383-390
4 Grissom A A Friend P J (2016) Multigene Panel Testing for Hereditary Cancer Risk Journal of the advanced practitioner in oncology 7(4) 394-
407
5 Lorans M Dow E Macrae FA Winship IM Buchanan DD (2018) Update on Hereditary Colorectal Cancer Improving the Clinical Utility of
Multigene Panel Testing Clin Colorectal Cancer 17(2)e293-e305
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG16
1 Ledermann PARP inhibitors in ovarian cancer Annals of Oncology (2016) 27 i40ndashi44
2 Koczkowska M et al Detection of somatic BRCA12 mutations in ovarian cancer - next-generation sequencing analysis of 100 cases Cancer Med
2016 Jul5(7)1640-6
3 Dougherty BA et al Biological and clinical evidence for somatic mutations in BRCA1 and BRCA2 as predictive markers for olaparib response in
high-grade serous ovarian cancers in the maintenance setting Oncotarget 2017 Jul 48(27)43653-43661
4 Maxwell KN et al BRCA locus-specific loss of heterozygosity in germline BRCA1 and BRCA2 carriers Nat Commun 2017 Aug 228(1)319
5 httpswwwagilentcomcslibrarybrochuresBrochure20Complete20solution20BRCA20MASTR20(Plus)20Dx20v1708pdf
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG17
1 MRC-Holland ndash MLPA General Protocol httpswwwmlpacom
2 Ticha I Kleibl Z Stribrna J a kol Screening for genomic rearragements in a genes in Czech high-risk breastovarian cancer patients high
proportion of population specific alterations in gene Breast Cancer Research and Treatment 2010 124 (2)337-347
3 Sluiter MD van Rensburg EJ Large genomic rearragements of the BRCA1 and BRCA2 genes review of the literature and report of a novel BRCA1
mutation Breast Cancer Research and Treatment 2011 125 325-349
Osoby spocircsobileacute modifikovať a validovať metoacutedy na Oddeleniacute lekaacuterskej genetiky
Meno a priezvisko tituly Spocircsobilosť modifikovať a validovať metoacutedy
ndash čiacuteslo položky v rozsahu akreditaacutecie
Regiacutena Lohajovaacute Behulovaacute RNDr PhD 11 až 61
Katariacutena Zaacutevodnaacute RNDr PhD 11 až 61
Ľudmila Vavrovaacute Ing PhD 11 až 61
Tomaacuteš Slamka Mgr 11 až 61
Lukaacuteš Šebest Mgr PhD 11 až 61
Aster Alemayehu RNDr PhD 11 až 61
13 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Použiteacute skratky
AGLUT ndash aglutinačnaacute reakcia
AOD ndash askorbaacutetoxidaacuteza
BRCA ndash označenie geacutenu asociovaneacuteho s dedičnou formou mamaacuternehoovariaacutelneho karcinoacutemu
CDKN2A ndash označenie geacutenu asociovaneacuteho s dedičnou formou maliacutegneho melanoacutemu
E6E7 - HPV viacuterusoveacute onkogeacuteny asociovaneacute so vznikom a progresiou Ca krčka maternice
FOTO - fotometria
GLD ndash glutamaacutetdehydrogenaacuteza
GPO ndash glycerol-3-fosfaacutet-oxidaacuteza
HPLC ndash High Performance Liquid Chromatography
HPV ndash human papillomavirus (ľudskyacute papilloma viacuterus)
CHOD ndash cholesteroloxidaacuteza
IFCC ndash International Federation for Clinical Chemistry
IMF ndash meranie fluorescencie po značeniacute buniek protilaacutetkami
KOAG ndash Coagulation Point Detection Method
KRAS ndash označenie geacutenu kt somatickeacute mutaacutecie v suacute predikatiacutevnym markerom pri metastazujuacutecom ca hrubeacuteho čreva
LATEX ndash Latex immunoassay method
MLH1 - označenie geacutenu asociovaneacuteho s dedičnou formou kolorektaacutelneho karcinoacutemu
MSH2 - označenie geacutenu asociovaneacuteho s dedičnou formou kolorektaacutelneho karcinoacutemu
NRAS ndash označenie geacutenu kt somatickeacute mutaacutecie v suacute predikatiacutevnym markerom pri metastazujuacutecom ca hrubeacuteho čreva
OHT - Oddelenie hematoloacutegie a transfuzioloacutegie
OID ndash Oddelenie imunodiagnostiky
OKB ndash Oddelenie klinickej biocheacutemie
OKIA - Oddelenie klinickej imunoloacutegie a alergoloacutegie
OKPC - Oddelenie klinickej patoloacutegie a cytoloacutegie
OLG ndash Oddelenie lekaacuterskej genetiky
PAP ndash peroxidaacuteza
PCR ndash polymeraacutezovaacute reťazovaacute reakcia
PHOTO ndash spektrofotometrickaacute metoacuteda
PLP ndash pyridoxalfosfaacutet
POD ndash peroxidaacuteza
RET ndash označenie geacutenu v dedičnej forme medulaacuterneho karcinoacutemu a syndroacutemu mnohopočetnej endokrinnej neoplaacutezie typu 2
RIA - Radio Immunoassay
RT - Real-Time
ŠPP ndash Štandardnyacute pracovnyacute postup
TPO ndash Tyreoidaacutelna peroxidaacuteza
TRACE ndash Time Resolved Amplified Cryptate Emission
9 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
7 Pathology and Genetics of Tumours of the Breast and Female Genital Organs ed Fattaneh ATavassoli Peter Devilee IARCPress 2003
8 Pathology and Genetics of Tumours of the Digestive System ed Stanley R Hamilton Lauri A Aaltonen IARCPress 2000
9 Pathology and Genetics of Tumours of Soft Tissue and Bone ed Christopher D M
10 Fletcher K Krishnan Unni Fredrik Mertens IARCPress 2002
11 Pathology and Genetics of Tumours of the Urinary System and Male Genital Organs ed John N Eble Guido Sauter Jonathan I Epstein Isabell A
Sesterhenn IARCPress 2004
12 Pathology and Genetics of Tumours of the Nervous System ed Paul Kleihnes Webster K Cavenee IARCPress 2000
13 Blausteinrsquos Pathology of the Female Genital Tract ed Robert J Kurman Springer-Verlag
New York 2002
14 Rosen P P Rosenrsquos Breast Pathology Lippincott WilliamsampWilkins 2001
Literatuacutera použitaacute v ŠPP OKPC04
1 Gomolčaacutek P Zaacuteklady imunohistocheacutemie v patoloacutegii IDVPZ Brno 1997 92 s ISBN 80-7013-239-6
2 Key M et al Immunohistochemical staining methods fourth edition education guide DAKO corporatio Carpinteacuteria California 2006 174 s
3 Lukaacuteš Z Draacuteberovaacute E Feit J Vojtěšek B Imunohistochemickeacute metody v biologii a v bioptickeacute diagnostice Acta facultatis medicae Universitatis
Masarykianae Brunensis Sborniacutek praciacute LF v Brně č 112 LF Masarykovy University Brno 1997 147 s ISBN 80-210-0620-X
4 Taylor CR Cote RJ Immunomicroscopy a diagnostic tool for the surgical pathologist third edition Saunders Elsevier 2006 531 s ISBN
0721601820
5 httpwwwihcworldcom
6 httpdistdakocom
7 Shi S-R Key ME Kalra KL Antigen retrieval in formalinfixed paraffin-embedded tissues an enhancement method for immunohistochemical
staining based on microwave oven heating of tissue sections J Histochem Cytochem 1991 39(6) 741-748
8 Shi S-R Cote RJ Taylor CR Antigen retrieval immunohistochemistry past present and future J Histochem Cytochem 1997 45 (3) 327-343
9 Miller RT Technical immunohistochemistry achieving reliability and reproducibility of immunostains [online] New York Society for Applied
Immunohistochemistry Annual Meeting 2001 [cit 2008-12-12] Dostupneacute na lthttpwwwihcworldcom_booksTechnical-IHCpdfgt
Literatuacutera použitaacute v ŠPP OKPC05
1 WiedGKeebler CM Koos LG Patten SFRosenthal DL Compendium on Diagnostic Cytology
2 Richard M De May The Art and Science of Cytopathology
3 Adam P Taborskyacute L Sobek O Kolbich PCytogy of cerebrospinal fluid
4 Takahashi MColor atlas of cancer cytology
Literatuacutera použitaacute v ŠPP OKPC06
1 WiedGKeebler CM Koos LG Patten SFRosenthal DL Compendium on Diagnostic Cytology
2 Richard M De May The Art and Science of Cytopathology
3 JKobilkovaacute JSirackyacute a kolCytodiagnostika v gynekologii
4 JKobilkovaacuteZLojdaJOndrušABekovaacute Gynekologickaacute cytodiagnostika
5 JKobilkovaacute Zaacuteklady cytopatoloacutegie
10 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Flexibilnyacute rozsah akreditaacutecie
Naacutezov akreditovaneacuteho subjektu Onkologickyacute uacutestav sv Alžbety sro
Heydukova 10 812 50 Bratislava
Uacutestav laboratoacuternej mediciacuteny SZU a OUacuteSA
Oddelenie lekaacuterskej genetiky
Flexibilnyacute rozsah akreditaacutecie je zverejnenyacute na adrese
httpwwwousask_imgDocumentsDocumentyZoznam_akreditovanych_cinnostipdf
Polo
žka Objekt skuacutešky Zavedenaacute metoacuteda
Ostatneacute
špecifikaacutecie Systeacutem
Biologickyacute
materiaacutel
Analyt
Ukazovateľ
Princiacutep
Druh
Typ
Označenie
1 Analyacuteza germinatiacutevnych variantov
11
Ľudskaacute
perifeacuterna krv
-Germinatiacutevne varianty v geacutene
BRCA12
Izolaacutecia DNA
PCR
amplifikaacutecia
Sekvenačnaacute
analyacuteza
ŠPP OLG1
(dolu uved orig
praacutece)
Kvalitatiacutevna skuacuteška
12 -Germinatiacutevne varianty v geacutene RET
Izolaacutecia DNA
PCR
amplifikaacutecia
Sekvenačnaacute
analyacuteza
ŠPP OLG2
(dolu uved orig
praacutece)
13 - - Docirckaz germinatiacutevnych variantov v
geacutene MLH1 a MSH2
Izolaacutecia DNA
PCR
amplifikaacutecia
Sekvenačnaacute
analyacuteza
ŠPP OLG10
(dolu uved orig
praacutece)
14 - - Docirckaz germinatiacutevnych variantov
v geacutene VHL
Izolaacutecia DNA
PCR
amplifikaacutecia
Sekvenačnaacute
analyacuteza
SPP OLG14
(dolu uvedeneacute
origpraacutece)
15
- - Docirckaz germinatiacutevnych variantov
v paneli geacutenov asociovanyacutech
s onkologickyacutemi hereditaacuternymi
syndroacutemami
Izolaacutecia DNA
PCR
amplifikaacutecia
Sekvenačnaacute
analyacuteza
SPP OLG15
(dolu uvedeneacute
origpraacutece)
2 Analyacuteza somatickyacutech variantov
21
Fixovaneacute
natiacutevne tkanivo
- Docirckaz somatickyacutech variantov
v exoacutenoch 2 3 a 4 geacutenu KRAS a
NRAS pri naacutedoroch kolorekta
Izolaacutecia DNA
PCR
amplifikaacutecia
Mini-sekvenačnaacute
analyacuteza
Real-Time PCR
ŠPP OLG5
(dolu uved orig
praacutece)
Kvalitatiacutevna skuacuteška 22
- Docirckaz somatickyacutech variantov
v kodoacutene 600 geacutenu BRAF pri
naacutedoroch štiacutetnej žľazy a maliacutegnom
melanoacuteme
Izolaacutecia DNA
PCR
amplifikaacutecia
Mini-sekvenačnaacute
analyacuteza
Real-Time PCR
ŠPP OLG9
(dolu uved orig
praacutece)
ŠPP OLG5
(dolu uved orig
praacutece)
23
Fixovaneacute
natiacutevne
tkanivocytologi
ckeacute stery
- Docirckaz somatickyacutech variantov
v exoacutenoch 18 19 20 a 21 geacutenu
EGFR pri nemalobunkovom
karcinoacuteme pľuacutec
Izolaacutecia DNA
PCR
amplifikaacutecia
Mini-sekvenačnaacute
analyacuteza
Real-Time PCR
ŠPP OLG11
(dolu uved orig
praacutece)
ŠPP OLG5
(dolu uved orig
praacutece)
11 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Polo
žka Objekt skuacutešky Zavedenaacute metoacuteda
Ostatneacute
špecifikaacutecie Systeacutem
Biologickyacute
materiaacutel
Analyt
Ukazovateľ
Princiacutep
Druh
Typ
Označenie
24 Fixovaneacute
natiacutevne tkanivo
-Docirckaz somatickyacutech variantov
v geacutene BRCA12
Izolaacutecia DNA
PCR
amplifikaacutecia
Sekvenačnaacute
analyacuteza
Mini-skevenačnaacute
analyacuteza
ŠPP OLG16
(dolu uved orig
praacutece)
Kvalitatiacutevna skuacuteška
4 Genotypizaacutecia ľudskyacutech papilomaviacuterusov
41
Bunkovaacute
suzpenzia
fixovaneacute
tkanivo
perifeacuterna krv
-Genotypizaacutecia HPV
Izolaacutecia DNA
PCR
amplifikaacutecia
Real-Time PCR
ŠPP OLG3
(dolu uved orig
praacutece)
Kvalitatiacutevna skuacuteška
5 Docirckaz priacutetomnosti HPV
51 Bunkovaacute
suzpenzia -Docirckaz priacutetomnosti HPV
Izolaacutecia DNA
Real-Time PCR
ŠPP OLG13
(dolu uved orig
praacutece)
Kvalitatiacutevna skuacuteška
6 Docirckaz veľkyacutech geacutenovyacutech prestavieb v geacutenoch asociovanyacutech s onkologickyacutemi hereditaacuternymi syndroacutemami metoacutedou MLPA
61
Ľudskaacute
perifeacuterna krv
Fixovaneacute
natiacutevne tkanivo
- - Docirckaz veľkyacutech geacutenovyacutech
prestavieb v geacutenoch asociovanyacutech s
onkologickyacutemi hereditaacuternymi
syndroacutemami metoacutedou MLPA
Izolaacutecia DNA
PCR
amplifikaacutecia
Fragmentačnaacute
analyacuteza
SPP OLG17
(dolu uvedeneacute
origpraacutece)
Kvalitatiacutevna skuacuteška
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG1
1 Friedman L Ostermeyer E A Szabo CI a kol Confirmation of BRCA1 by analysis of germline mutations linked to breast and ovarian cancer in
ten families Nat Genetics 8 399-404 1994
2 Miki Y Katagiri T Kasumi F a kol Mutation analysis in the BRCA2 gene in primary breast cancer Nat Genetics 2 245-7 1996
3 Wagner T M U Hirtenlehner K Shen P a kol Global sequence diversity of BRCA2 analysis of 71 breast cancer families and 95 control
individuals of worldwilde populatins Hum Mol Genetocs Vol 8 No 3 1999
4 QIAamp DNA Mini Kit and OIAamp DNA Blood Mini Kit Handbook
5 Nanodrop ND 1000 useracutes manual
6 Promega Protocols and applications guide The Source for Discovery PCR cheapter Promega Corporation USA 1996
7 Amersham Pharmacia Biotech DNA Silver Staining Kit instructions
8 BigDye Terminator v 11 Cycle Sequencing Kit Protokol Applied Biosystems
9 Applied Biosystems DNA Sequencing Analysis Software Version 51 for Windows XP and 2000 Platforms User Guide Applied Biosystems
10 Applied Biosystems 31303130xl Genetic Analyzers Getting Started Guide Applied Biosystems
11 Konecny M et al Comprehensive genetic characterization of hereditary breastovarian cancer families from Slovakia Breast Cancer Res Treat
(2011) 126119ndash130
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG2
1 Ceccherini I Hofstra RMW Luo Y a kol DNA polymorphisms and conditions for SSCP analysis of the 20 exons of the RET proto-oncogene
Oncogene 9 3025-3029 1994
2 De Groot et al RET as a dignostic and therapeutic target in sporadic and hereditary endocrine tumors 2006 Endocrine Reviews 27(5) 535-560
3 Martucciello G Lerone M et al Multiple endocrine neoplasias type 2B and RET proto-oncogene Ital J Pediatr 2012 Mar 19389 doi
1011861824-7288-38-9 Review
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG3
1 Weismanovaacute E Weismann P Vizvaacuteryovaacute M a kol New approach to human high-risk papillomavirus (HR-HPV) genotyping Neoplasma 49
217-224 2002
2 Amersham Biosciences GenomicPrep Cells and Tissue DNA Isolation Kit instructions
3 Amersham Pharmacia Biotech QuickPrep Total RNA Extraction Kit instructions
4 Amersham Pharmacia Biotech Ready To Go You-Prime First-Strand Beads instructions
5 Amersham Pharmacia Biotech Ready To Go PCR Beads instructions
6 Amersham Pharmacia Biotech DNA Silver Staining Kit instructions
7 F-HPV typingTM Kit Manual
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG5
1 Van Krieken J H J M Jung A Kirchner T a kol KRAS mutation testing for predicting response to anti-EGFR therapy for colorectal carcinoma
proposal for an European quality assurance program Virchows Arch (2008) 453417-431
2 Lievre A Bachet J Le Corre D a kol KRAS mutation status is predictive of response to cetuximab therapy in colorectal cancer Cancer Res
(2006) 668
3 TheraScreen K-RAS Mutation Manual
4 BigDye Terminator v 11 Cycle Sequencing Kit Protokol Applied Biosystems
5 Applied Biosystems DNA Sequencing Analysis Software Version 51 for Windows XP and 2000 Platforms User Guide Applied Biosystems
6 Applied Biosystems 3500 Genetic Analyzers Getting Started Guide Applied Biosystems
8 SNaPshot Multiplex Kit ndash protocol and manual
12 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG9 1 Nikiforov YE thyroid carcinoma molecular pathways and therapeutic targets Modern pathology 21S37-S43 2008
2 Elisei R Ugolini C Viola D Lupi C et al BRAF V600E mutation and outcome of patients with papillary thyroid carcinoma
A 15-year median follow-up study J Clin endocrine Metab 93(10)3943-3949 2008
3 SNaPshot Multiplex Kit ndash protocol and manual Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG10
1 Brigitte Wolf Silvia Henglmueller at al Spectrum of germ-line MLH1 and MSH2 mutations in Austrian patientswith hereditary nonpolyposis
colorectal cancer The Middle European Journal of Medicine 2005 1177ndash8 269ndash277
2 Elisabeth mangold Constanze Pagenstecher et al Spectrum and frequencies of mutations in MSH2 and MLH1 identified in 1721 german families
suspected of hereditary nonpolyposis colorectal cancer Int J Cancer 2005 116 692-702
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG11
1 Rosell R Moran T Queralt C Porta R Cardenal F Camps C Majem M Lopez-Vivanco G Isla D Provencio M Insa A Massuti
B Gonzalez-Larriba J L Paz-Ares L Bover I Garcia-Campelo R Moreno M A Catot S Rolfo C Reguart N Palmero R Sanchez
JM Bastus R Mayo C Bertran- Alamillo J Molina M A Sanchez J J Taron M (2009) Screening for epidermal growth factor receptor
mutations in lung cancer N Engl J Med 361 958-967
2 Peacuterez-Soler R Chachoua A Hammond L A Rowinsky E K Huberman M Karp M Rigas J Clark G M Santabaacuterbara P Bonomi P
(2004) Determinants of Tumor Response and Survival With Erlotinib in Patients With NonndashSmall-Cell Lung Cancer Journal og Clinical
Oncology 22 16
3 Pines G Koumlstler W JYosef Yarden Department of Biological Regulation The Weizmann Institute of Science Rehovot 76100 Israel (2010)
Oncogenic mutant forms of EGFR lessons in signal transduction and targets for cancer therapy FEBSLett 584 (12) 2699ndash2706
4 ABI PRISM SnaPshot Multiplex Kit ndashProtocol and manual
5 cobasreg EGFR Mutation Test ndash User Manual
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG13
1 cobasreg 4800 HPV Test ndash Dokument č 05990343001-04SK Roche Diagnostics GmbH
2cobasreg 4800 HPV Test ndash Dokument č 05641268001-01 Roche Molecular Systems Inc
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG14
1 Nielsen SM Rhodes L Blanco I a kol 2016 Von Hippel-Lindau Disease Genetics and Role of Genetic Counseling in a Multiple Neoplasia
Syndrome J Clin Oncol 34(18)2172-2181
2 Alberta Health Services 2011 Renal cell carcinoma and genetic testing Clinical Practice Guideline GU-005
3 Chittiboina P Lonser RR 2015 Von Hippel-Lindau disease Handb Clin Neurol132139-156
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG15
1 Hereditary Cancer Solution by Sophia Genetics ndash Users guide using DNA library prep kit by Sophia genetics 48 samples
2 BRCA Hereditary Cancer MASTR Plus kit with drMID for Ilumina NGS systems ndash instructions for use
3 Crawford B Adams S B Sittler et al (2017) Multi-gene panel testing for hereditary cancer predisposition in unsolved high-risk breast and ovarian
cancer patients Breast cancer research and treatment 163(2) 383-390
4 Grissom A A Friend P J (2016) Multigene Panel Testing for Hereditary Cancer Risk Journal of the advanced practitioner in oncology 7(4) 394-
407
5 Lorans M Dow E Macrae FA Winship IM Buchanan DD (2018) Update on Hereditary Colorectal Cancer Improving the Clinical Utility of
Multigene Panel Testing Clin Colorectal Cancer 17(2)e293-e305
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG16
1 Ledermann PARP inhibitors in ovarian cancer Annals of Oncology (2016) 27 i40ndashi44
2 Koczkowska M et al Detection of somatic BRCA12 mutations in ovarian cancer - next-generation sequencing analysis of 100 cases Cancer Med
2016 Jul5(7)1640-6
3 Dougherty BA et al Biological and clinical evidence for somatic mutations in BRCA1 and BRCA2 as predictive markers for olaparib response in
high-grade serous ovarian cancers in the maintenance setting Oncotarget 2017 Jul 48(27)43653-43661
4 Maxwell KN et al BRCA locus-specific loss of heterozygosity in germline BRCA1 and BRCA2 carriers Nat Commun 2017 Aug 228(1)319
5 httpswwwagilentcomcslibrarybrochuresBrochure20Complete20solution20BRCA20MASTR20(Plus)20Dx20v1708pdf
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG17
1 MRC-Holland ndash MLPA General Protocol httpswwwmlpacom
2 Ticha I Kleibl Z Stribrna J a kol Screening for genomic rearragements in a genes in Czech high-risk breastovarian cancer patients high
proportion of population specific alterations in gene Breast Cancer Research and Treatment 2010 124 (2)337-347
3 Sluiter MD van Rensburg EJ Large genomic rearragements of the BRCA1 and BRCA2 genes review of the literature and report of a novel BRCA1
mutation Breast Cancer Research and Treatment 2011 125 325-349
Osoby spocircsobileacute modifikovať a validovať metoacutedy na Oddeleniacute lekaacuterskej genetiky
Meno a priezvisko tituly Spocircsobilosť modifikovať a validovať metoacutedy
ndash čiacuteslo položky v rozsahu akreditaacutecie
Regiacutena Lohajovaacute Behulovaacute RNDr PhD 11 až 61
Katariacutena Zaacutevodnaacute RNDr PhD 11 až 61
Ľudmila Vavrovaacute Ing PhD 11 až 61
Tomaacuteš Slamka Mgr 11 až 61
Lukaacuteš Šebest Mgr PhD 11 až 61
Aster Alemayehu RNDr PhD 11 až 61
13 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Použiteacute skratky
AGLUT ndash aglutinačnaacute reakcia
AOD ndash askorbaacutetoxidaacuteza
BRCA ndash označenie geacutenu asociovaneacuteho s dedičnou formou mamaacuternehoovariaacutelneho karcinoacutemu
CDKN2A ndash označenie geacutenu asociovaneacuteho s dedičnou formou maliacutegneho melanoacutemu
E6E7 - HPV viacuterusoveacute onkogeacuteny asociovaneacute so vznikom a progresiou Ca krčka maternice
FOTO - fotometria
GLD ndash glutamaacutetdehydrogenaacuteza
GPO ndash glycerol-3-fosfaacutet-oxidaacuteza
HPLC ndash High Performance Liquid Chromatography
HPV ndash human papillomavirus (ľudskyacute papilloma viacuterus)
CHOD ndash cholesteroloxidaacuteza
IFCC ndash International Federation for Clinical Chemistry
IMF ndash meranie fluorescencie po značeniacute buniek protilaacutetkami
KOAG ndash Coagulation Point Detection Method
KRAS ndash označenie geacutenu kt somatickeacute mutaacutecie v suacute predikatiacutevnym markerom pri metastazujuacutecom ca hrubeacuteho čreva
LATEX ndash Latex immunoassay method
MLH1 - označenie geacutenu asociovaneacuteho s dedičnou formou kolorektaacutelneho karcinoacutemu
MSH2 - označenie geacutenu asociovaneacuteho s dedičnou formou kolorektaacutelneho karcinoacutemu
NRAS ndash označenie geacutenu kt somatickeacute mutaacutecie v suacute predikatiacutevnym markerom pri metastazujuacutecom ca hrubeacuteho čreva
OHT - Oddelenie hematoloacutegie a transfuzioloacutegie
OID ndash Oddelenie imunodiagnostiky
OKB ndash Oddelenie klinickej biocheacutemie
OKIA - Oddelenie klinickej imunoloacutegie a alergoloacutegie
OKPC - Oddelenie klinickej patoloacutegie a cytoloacutegie
OLG ndash Oddelenie lekaacuterskej genetiky
PAP ndash peroxidaacuteza
PCR ndash polymeraacutezovaacute reťazovaacute reakcia
PHOTO ndash spektrofotometrickaacute metoacuteda
PLP ndash pyridoxalfosfaacutet
POD ndash peroxidaacuteza
RET ndash označenie geacutenu v dedičnej forme medulaacuterneho karcinoacutemu a syndroacutemu mnohopočetnej endokrinnej neoplaacutezie typu 2
RIA - Radio Immunoassay
RT - Real-Time
ŠPP ndash Štandardnyacute pracovnyacute postup
TPO ndash Tyreoidaacutelna peroxidaacuteza
TRACE ndash Time Resolved Amplified Cryptate Emission
10 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Flexibilnyacute rozsah akreditaacutecie
Naacutezov akreditovaneacuteho subjektu Onkologickyacute uacutestav sv Alžbety sro
Heydukova 10 812 50 Bratislava
Uacutestav laboratoacuternej mediciacuteny SZU a OUacuteSA
Oddelenie lekaacuterskej genetiky
Flexibilnyacute rozsah akreditaacutecie je zverejnenyacute na adrese
httpwwwousask_imgDocumentsDocumentyZoznam_akreditovanych_cinnostipdf
Polo
žka Objekt skuacutešky Zavedenaacute metoacuteda
Ostatneacute
špecifikaacutecie Systeacutem
Biologickyacute
materiaacutel
Analyt
Ukazovateľ
Princiacutep
Druh
Typ
Označenie
1 Analyacuteza germinatiacutevnych variantov
11
Ľudskaacute
perifeacuterna krv
-Germinatiacutevne varianty v geacutene
BRCA12
Izolaacutecia DNA
PCR
amplifikaacutecia
Sekvenačnaacute
analyacuteza
ŠPP OLG1
(dolu uved orig
praacutece)
Kvalitatiacutevna skuacuteška
12 -Germinatiacutevne varianty v geacutene RET
Izolaacutecia DNA
PCR
amplifikaacutecia
Sekvenačnaacute
analyacuteza
ŠPP OLG2
(dolu uved orig
praacutece)
13 - - Docirckaz germinatiacutevnych variantov v
geacutene MLH1 a MSH2
Izolaacutecia DNA
PCR
amplifikaacutecia
Sekvenačnaacute
analyacuteza
ŠPP OLG10
(dolu uved orig
praacutece)
14 - - Docirckaz germinatiacutevnych variantov
v geacutene VHL
Izolaacutecia DNA
PCR
amplifikaacutecia
Sekvenačnaacute
analyacuteza
SPP OLG14
(dolu uvedeneacute
origpraacutece)
15
- - Docirckaz germinatiacutevnych variantov
v paneli geacutenov asociovanyacutech
s onkologickyacutemi hereditaacuternymi
syndroacutemami
Izolaacutecia DNA
PCR
amplifikaacutecia
Sekvenačnaacute
analyacuteza
SPP OLG15
(dolu uvedeneacute
origpraacutece)
2 Analyacuteza somatickyacutech variantov
21
Fixovaneacute
natiacutevne tkanivo
- Docirckaz somatickyacutech variantov
v exoacutenoch 2 3 a 4 geacutenu KRAS a
NRAS pri naacutedoroch kolorekta
Izolaacutecia DNA
PCR
amplifikaacutecia
Mini-sekvenačnaacute
analyacuteza
Real-Time PCR
ŠPP OLG5
(dolu uved orig
praacutece)
Kvalitatiacutevna skuacuteška 22
- Docirckaz somatickyacutech variantov
v kodoacutene 600 geacutenu BRAF pri
naacutedoroch štiacutetnej žľazy a maliacutegnom
melanoacuteme
Izolaacutecia DNA
PCR
amplifikaacutecia
Mini-sekvenačnaacute
analyacuteza
Real-Time PCR
ŠPP OLG9
(dolu uved orig
praacutece)
ŠPP OLG5
(dolu uved orig
praacutece)
23
Fixovaneacute
natiacutevne
tkanivocytologi
ckeacute stery
- Docirckaz somatickyacutech variantov
v exoacutenoch 18 19 20 a 21 geacutenu
EGFR pri nemalobunkovom
karcinoacuteme pľuacutec
Izolaacutecia DNA
PCR
amplifikaacutecia
Mini-sekvenačnaacute
analyacuteza
Real-Time PCR
ŠPP OLG11
(dolu uved orig
praacutece)
ŠPP OLG5
(dolu uved orig
praacutece)
11 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Polo
žka Objekt skuacutešky Zavedenaacute metoacuteda
Ostatneacute
špecifikaacutecie Systeacutem
Biologickyacute
materiaacutel
Analyt
Ukazovateľ
Princiacutep
Druh
Typ
Označenie
24 Fixovaneacute
natiacutevne tkanivo
-Docirckaz somatickyacutech variantov
v geacutene BRCA12
Izolaacutecia DNA
PCR
amplifikaacutecia
Sekvenačnaacute
analyacuteza
Mini-skevenačnaacute
analyacuteza
ŠPP OLG16
(dolu uved orig
praacutece)
Kvalitatiacutevna skuacuteška
4 Genotypizaacutecia ľudskyacutech papilomaviacuterusov
41
Bunkovaacute
suzpenzia
fixovaneacute
tkanivo
perifeacuterna krv
-Genotypizaacutecia HPV
Izolaacutecia DNA
PCR
amplifikaacutecia
Real-Time PCR
ŠPP OLG3
(dolu uved orig
praacutece)
Kvalitatiacutevna skuacuteška
5 Docirckaz priacutetomnosti HPV
51 Bunkovaacute
suzpenzia -Docirckaz priacutetomnosti HPV
Izolaacutecia DNA
Real-Time PCR
ŠPP OLG13
(dolu uved orig
praacutece)
Kvalitatiacutevna skuacuteška
6 Docirckaz veľkyacutech geacutenovyacutech prestavieb v geacutenoch asociovanyacutech s onkologickyacutemi hereditaacuternymi syndroacutemami metoacutedou MLPA
61
Ľudskaacute
perifeacuterna krv
Fixovaneacute
natiacutevne tkanivo
- - Docirckaz veľkyacutech geacutenovyacutech
prestavieb v geacutenoch asociovanyacutech s
onkologickyacutemi hereditaacuternymi
syndroacutemami metoacutedou MLPA
Izolaacutecia DNA
PCR
amplifikaacutecia
Fragmentačnaacute
analyacuteza
SPP OLG17
(dolu uvedeneacute
origpraacutece)
Kvalitatiacutevna skuacuteška
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG1
1 Friedman L Ostermeyer E A Szabo CI a kol Confirmation of BRCA1 by analysis of germline mutations linked to breast and ovarian cancer in
ten families Nat Genetics 8 399-404 1994
2 Miki Y Katagiri T Kasumi F a kol Mutation analysis in the BRCA2 gene in primary breast cancer Nat Genetics 2 245-7 1996
3 Wagner T M U Hirtenlehner K Shen P a kol Global sequence diversity of BRCA2 analysis of 71 breast cancer families and 95 control
individuals of worldwilde populatins Hum Mol Genetocs Vol 8 No 3 1999
4 QIAamp DNA Mini Kit and OIAamp DNA Blood Mini Kit Handbook
5 Nanodrop ND 1000 useracutes manual
6 Promega Protocols and applications guide The Source for Discovery PCR cheapter Promega Corporation USA 1996
7 Amersham Pharmacia Biotech DNA Silver Staining Kit instructions
8 BigDye Terminator v 11 Cycle Sequencing Kit Protokol Applied Biosystems
9 Applied Biosystems DNA Sequencing Analysis Software Version 51 for Windows XP and 2000 Platforms User Guide Applied Biosystems
10 Applied Biosystems 31303130xl Genetic Analyzers Getting Started Guide Applied Biosystems
11 Konecny M et al Comprehensive genetic characterization of hereditary breastovarian cancer families from Slovakia Breast Cancer Res Treat
(2011) 126119ndash130
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG2
1 Ceccherini I Hofstra RMW Luo Y a kol DNA polymorphisms and conditions for SSCP analysis of the 20 exons of the RET proto-oncogene
Oncogene 9 3025-3029 1994
2 De Groot et al RET as a dignostic and therapeutic target in sporadic and hereditary endocrine tumors 2006 Endocrine Reviews 27(5) 535-560
3 Martucciello G Lerone M et al Multiple endocrine neoplasias type 2B and RET proto-oncogene Ital J Pediatr 2012 Mar 19389 doi
1011861824-7288-38-9 Review
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG3
1 Weismanovaacute E Weismann P Vizvaacuteryovaacute M a kol New approach to human high-risk papillomavirus (HR-HPV) genotyping Neoplasma 49
217-224 2002
2 Amersham Biosciences GenomicPrep Cells and Tissue DNA Isolation Kit instructions
3 Amersham Pharmacia Biotech QuickPrep Total RNA Extraction Kit instructions
4 Amersham Pharmacia Biotech Ready To Go You-Prime First-Strand Beads instructions
5 Amersham Pharmacia Biotech Ready To Go PCR Beads instructions
6 Amersham Pharmacia Biotech DNA Silver Staining Kit instructions
7 F-HPV typingTM Kit Manual
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG5
1 Van Krieken J H J M Jung A Kirchner T a kol KRAS mutation testing for predicting response to anti-EGFR therapy for colorectal carcinoma
proposal for an European quality assurance program Virchows Arch (2008) 453417-431
2 Lievre A Bachet J Le Corre D a kol KRAS mutation status is predictive of response to cetuximab therapy in colorectal cancer Cancer Res
(2006) 668
3 TheraScreen K-RAS Mutation Manual
4 BigDye Terminator v 11 Cycle Sequencing Kit Protokol Applied Biosystems
5 Applied Biosystems DNA Sequencing Analysis Software Version 51 for Windows XP and 2000 Platforms User Guide Applied Biosystems
6 Applied Biosystems 3500 Genetic Analyzers Getting Started Guide Applied Biosystems
8 SNaPshot Multiplex Kit ndash protocol and manual
12 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG9 1 Nikiforov YE thyroid carcinoma molecular pathways and therapeutic targets Modern pathology 21S37-S43 2008
2 Elisei R Ugolini C Viola D Lupi C et al BRAF V600E mutation and outcome of patients with papillary thyroid carcinoma
A 15-year median follow-up study J Clin endocrine Metab 93(10)3943-3949 2008
3 SNaPshot Multiplex Kit ndash protocol and manual Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG10
1 Brigitte Wolf Silvia Henglmueller at al Spectrum of germ-line MLH1 and MSH2 mutations in Austrian patientswith hereditary nonpolyposis
colorectal cancer The Middle European Journal of Medicine 2005 1177ndash8 269ndash277
2 Elisabeth mangold Constanze Pagenstecher et al Spectrum and frequencies of mutations in MSH2 and MLH1 identified in 1721 german families
suspected of hereditary nonpolyposis colorectal cancer Int J Cancer 2005 116 692-702
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG11
1 Rosell R Moran T Queralt C Porta R Cardenal F Camps C Majem M Lopez-Vivanco G Isla D Provencio M Insa A Massuti
B Gonzalez-Larriba J L Paz-Ares L Bover I Garcia-Campelo R Moreno M A Catot S Rolfo C Reguart N Palmero R Sanchez
JM Bastus R Mayo C Bertran- Alamillo J Molina M A Sanchez J J Taron M (2009) Screening for epidermal growth factor receptor
mutations in lung cancer N Engl J Med 361 958-967
2 Peacuterez-Soler R Chachoua A Hammond L A Rowinsky E K Huberman M Karp M Rigas J Clark G M Santabaacuterbara P Bonomi P
(2004) Determinants of Tumor Response and Survival With Erlotinib in Patients With NonndashSmall-Cell Lung Cancer Journal og Clinical
Oncology 22 16
3 Pines G Koumlstler W JYosef Yarden Department of Biological Regulation The Weizmann Institute of Science Rehovot 76100 Israel (2010)
Oncogenic mutant forms of EGFR lessons in signal transduction and targets for cancer therapy FEBSLett 584 (12) 2699ndash2706
4 ABI PRISM SnaPshot Multiplex Kit ndashProtocol and manual
5 cobasreg EGFR Mutation Test ndash User Manual
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG13
1 cobasreg 4800 HPV Test ndash Dokument č 05990343001-04SK Roche Diagnostics GmbH
2cobasreg 4800 HPV Test ndash Dokument č 05641268001-01 Roche Molecular Systems Inc
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG14
1 Nielsen SM Rhodes L Blanco I a kol 2016 Von Hippel-Lindau Disease Genetics and Role of Genetic Counseling in a Multiple Neoplasia
Syndrome J Clin Oncol 34(18)2172-2181
2 Alberta Health Services 2011 Renal cell carcinoma and genetic testing Clinical Practice Guideline GU-005
3 Chittiboina P Lonser RR 2015 Von Hippel-Lindau disease Handb Clin Neurol132139-156
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG15
1 Hereditary Cancer Solution by Sophia Genetics ndash Users guide using DNA library prep kit by Sophia genetics 48 samples
2 BRCA Hereditary Cancer MASTR Plus kit with drMID for Ilumina NGS systems ndash instructions for use
3 Crawford B Adams S B Sittler et al (2017) Multi-gene panel testing for hereditary cancer predisposition in unsolved high-risk breast and ovarian
cancer patients Breast cancer research and treatment 163(2) 383-390
4 Grissom A A Friend P J (2016) Multigene Panel Testing for Hereditary Cancer Risk Journal of the advanced practitioner in oncology 7(4) 394-
407
5 Lorans M Dow E Macrae FA Winship IM Buchanan DD (2018) Update on Hereditary Colorectal Cancer Improving the Clinical Utility of
Multigene Panel Testing Clin Colorectal Cancer 17(2)e293-e305
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG16
1 Ledermann PARP inhibitors in ovarian cancer Annals of Oncology (2016) 27 i40ndashi44
2 Koczkowska M et al Detection of somatic BRCA12 mutations in ovarian cancer - next-generation sequencing analysis of 100 cases Cancer Med
2016 Jul5(7)1640-6
3 Dougherty BA et al Biological and clinical evidence for somatic mutations in BRCA1 and BRCA2 as predictive markers for olaparib response in
high-grade serous ovarian cancers in the maintenance setting Oncotarget 2017 Jul 48(27)43653-43661
4 Maxwell KN et al BRCA locus-specific loss of heterozygosity in germline BRCA1 and BRCA2 carriers Nat Commun 2017 Aug 228(1)319
5 httpswwwagilentcomcslibrarybrochuresBrochure20Complete20solution20BRCA20MASTR20(Plus)20Dx20v1708pdf
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG17
1 MRC-Holland ndash MLPA General Protocol httpswwwmlpacom
2 Ticha I Kleibl Z Stribrna J a kol Screening for genomic rearragements in a genes in Czech high-risk breastovarian cancer patients high
proportion of population specific alterations in gene Breast Cancer Research and Treatment 2010 124 (2)337-347
3 Sluiter MD van Rensburg EJ Large genomic rearragements of the BRCA1 and BRCA2 genes review of the literature and report of a novel BRCA1
mutation Breast Cancer Research and Treatment 2011 125 325-349
Osoby spocircsobileacute modifikovať a validovať metoacutedy na Oddeleniacute lekaacuterskej genetiky
Meno a priezvisko tituly Spocircsobilosť modifikovať a validovať metoacutedy
ndash čiacuteslo položky v rozsahu akreditaacutecie
Regiacutena Lohajovaacute Behulovaacute RNDr PhD 11 až 61
Katariacutena Zaacutevodnaacute RNDr PhD 11 až 61
Ľudmila Vavrovaacute Ing PhD 11 až 61
Tomaacuteš Slamka Mgr 11 až 61
Lukaacuteš Šebest Mgr PhD 11 až 61
Aster Alemayehu RNDr PhD 11 až 61
13 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Použiteacute skratky
AGLUT ndash aglutinačnaacute reakcia
AOD ndash askorbaacutetoxidaacuteza
BRCA ndash označenie geacutenu asociovaneacuteho s dedičnou formou mamaacuternehoovariaacutelneho karcinoacutemu
CDKN2A ndash označenie geacutenu asociovaneacuteho s dedičnou formou maliacutegneho melanoacutemu
E6E7 - HPV viacuterusoveacute onkogeacuteny asociovaneacute so vznikom a progresiou Ca krčka maternice
FOTO - fotometria
GLD ndash glutamaacutetdehydrogenaacuteza
GPO ndash glycerol-3-fosfaacutet-oxidaacuteza
HPLC ndash High Performance Liquid Chromatography
HPV ndash human papillomavirus (ľudskyacute papilloma viacuterus)
CHOD ndash cholesteroloxidaacuteza
IFCC ndash International Federation for Clinical Chemistry
IMF ndash meranie fluorescencie po značeniacute buniek protilaacutetkami
KOAG ndash Coagulation Point Detection Method
KRAS ndash označenie geacutenu kt somatickeacute mutaacutecie v suacute predikatiacutevnym markerom pri metastazujuacutecom ca hrubeacuteho čreva
LATEX ndash Latex immunoassay method
MLH1 - označenie geacutenu asociovaneacuteho s dedičnou formou kolorektaacutelneho karcinoacutemu
MSH2 - označenie geacutenu asociovaneacuteho s dedičnou formou kolorektaacutelneho karcinoacutemu
NRAS ndash označenie geacutenu kt somatickeacute mutaacutecie v suacute predikatiacutevnym markerom pri metastazujuacutecom ca hrubeacuteho čreva
OHT - Oddelenie hematoloacutegie a transfuzioloacutegie
OID ndash Oddelenie imunodiagnostiky
OKB ndash Oddelenie klinickej biocheacutemie
OKIA - Oddelenie klinickej imunoloacutegie a alergoloacutegie
OKPC - Oddelenie klinickej patoloacutegie a cytoloacutegie
OLG ndash Oddelenie lekaacuterskej genetiky
PAP ndash peroxidaacuteza
PCR ndash polymeraacutezovaacute reťazovaacute reakcia
PHOTO ndash spektrofotometrickaacute metoacuteda
PLP ndash pyridoxalfosfaacutet
POD ndash peroxidaacuteza
RET ndash označenie geacutenu v dedičnej forme medulaacuterneho karcinoacutemu a syndroacutemu mnohopočetnej endokrinnej neoplaacutezie typu 2
RIA - Radio Immunoassay
RT - Real-Time
ŠPP ndash Štandardnyacute pracovnyacute postup
TPO ndash Tyreoidaacutelna peroxidaacuteza
TRACE ndash Time Resolved Amplified Cryptate Emission
11 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Polo
žka Objekt skuacutešky Zavedenaacute metoacuteda
Ostatneacute
špecifikaacutecie Systeacutem
Biologickyacute
materiaacutel
Analyt
Ukazovateľ
Princiacutep
Druh
Typ
Označenie
24 Fixovaneacute
natiacutevne tkanivo
-Docirckaz somatickyacutech variantov
v geacutene BRCA12
Izolaacutecia DNA
PCR
amplifikaacutecia
Sekvenačnaacute
analyacuteza
Mini-skevenačnaacute
analyacuteza
ŠPP OLG16
(dolu uved orig
praacutece)
Kvalitatiacutevna skuacuteška
4 Genotypizaacutecia ľudskyacutech papilomaviacuterusov
41
Bunkovaacute
suzpenzia
fixovaneacute
tkanivo
perifeacuterna krv
-Genotypizaacutecia HPV
Izolaacutecia DNA
PCR
amplifikaacutecia
Real-Time PCR
ŠPP OLG3
(dolu uved orig
praacutece)
Kvalitatiacutevna skuacuteška
5 Docirckaz priacutetomnosti HPV
51 Bunkovaacute
suzpenzia -Docirckaz priacutetomnosti HPV
Izolaacutecia DNA
Real-Time PCR
ŠPP OLG13
(dolu uved orig
praacutece)
Kvalitatiacutevna skuacuteška
6 Docirckaz veľkyacutech geacutenovyacutech prestavieb v geacutenoch asociovanyacutech s onkologickyacutemi hereditaacuternymi syndroacutemami metoacutedou MLPA
61
Ľudskaacute
perifeacuterna krv
Fixovaneacute
natiacutevne tkanivo
- - Docirckaz veľkyacutech geacutenovyacutech
prestavieb v geacutenoch asociovanyacutech s
onkologickyacutemi hereditaacuternymi
syndroacutemami metoacutedou MLPA
Izolaacutecia DNA
PCR
amplifikaacutecia
Fragmentačnaacute
analyacuteza
SPP OLG17
(dolu uvedeneacute
origpraacutece)
Kvalitatiacutevna skuacuteška
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG1
1 Friedman L Ostermeyer E A Szabo CI a kol Confirmation of BRCA1 by analysis of germline mutations linked to breast and ovarian cancer in
ten families Nat Genetics 8 399-404 1994
2 Miki Y Katagiri T Kasumi F a kol Mutation analysis in the BRCA2 gene in primary breast cancer Nat Genetics 2 245-7 1996
3 Wagner T M U Hirtenlehner K Shen P a kol Global sequence diversity of BRCA2 analysis of 71 breast cancer families and 95 control
individuals of worldwilde populatins Hum Mol Genetocs Vol 8 No 3 1999
4 QIAamp DNA Mini Kit and OIAamp DNA Blood Mini Kit Handbook
5 Nanodrop ND 1000 useracutes manual
6 Promega Protocols and applications guide The Source for Discovery PCR cheapter Promega Corporation USA 1996
7 Amersham Pharmacia Biotech DNA Silver Staining Kit instructions
8 BigDye Terminator v 11 Cycle Sequencing Kit Protokol Applied Biosystems
9 Applied Biosystems DNA Sequencing Analysis Software Version 51 for Windows XP and 2000 Platforms User Guide Applied Biosystems
10 Applied Biosystems 31303130xl Genetic Analyzers Getting Started Guide Applied Biosystems
11 Konecny M et al Comprehensive genetic characterization of hereditary breastovarian cancer families from Slovakia Breast Cancer Res Treat
(2011) 126119ndash130
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG2
1 Ceccherini I Hofstra RMW Luo Y a kol DNA polymorphisms and conditions for SSCP analysis of the 20 exons of the RET proto-oncogene
Oncogene 9 3025-3029 1994
2 De Groot et al RET as a dignostic and therapeutic target in sporadic and hereditary endocrine tumors 2006 Endocrine Reviews 27(5) 535-560
3 Martucciello G Lerone M et al Multiple endocrine neoplasias type 2B and RET proto-oncogene Ital J Pediatr 2012 Mar 19389 doi
1011861824-7288-38-9 Review
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG3
1 Weismanovaacute E Weismann P Vizvaacuteryovaacute M a kol New approach to human high-risk papillomavirus (HR-HPV) genotyping Neoplasma 49
217-224 2002
2 Amersham Biosciences GenomicPrep Cells and Tissue DNA Isolation Kit instructions
3 Amersham Pharmacia Biotech QuickPrep Total RNA Extraction Kit instructions
4 Amersham Pharmacia Biotech Ready To Go You-Prime First-Strand Beads instructions
5 Amersham Pharmacia Biotech Ready To Go PCR Beads instructions
6 Amersham Pharmacia Biotech DNA Silver Staining Kit instructions
7 F-HPV typingTM Kit Manual
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG5
1 Van Krieken J H J M Jung A Kirchner T a kol KRAS mutation testing for predicting response to anti-EGFR therapy for colorectal carcinoma
proposal for an European quality assurance program Virchows Arch (2008) 453417-431
2 Lievre A Bachet J Le Corre D a kol KRAS mutation status is predictive of response to cetuximab therapy in colorectal cancer Cancer Res
(2006) 668
3 TheraScreen K-RAS Mutation Manual
4 BigDye Terminator v 11 Cycle Sequencing Kit Protokol Applied Biosystems
5 Applied Biosystems DNA Sequencing Analysis Software Version 51 for Windows XP and 2000 Platforms User Guide Applied Biosystems
6 Applied Biosystems 3500 Genetic Analyzers Getting Started Guide Applied Biosystems
8 SNaPshot Multiplex Kit ndash protocol and manual
12 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG9 1 Nikiforov YE thyroid carcinoma molecular pathways and therapeutic targets Modern pathology 21S37-S43 2008
2 Elisei R Ugolini C Viola D Lupi C et al BRAF V600E mutation and outcome of patients with papillary thyroid carcinoma
A 15-year median follow-up study J Clin endocrine Metab 93(10)3943-3949 2008
3 SNaPshot Multiplex Kit ndash protocol and manual Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG10
1 Brigitte Wolf Silvia Henglmueller at al Spectrum of germ-line MLH1 and MSH2 mutations in Austrian patientswith hereditary nonpolyposis
colorectal cancer The Middle European Journal of Medicine 2005 1177ndash8 269ndash277
2 Elisabeth mangold Constanze Pagenstecher et al Spectrum and frequencies of mutations in MSH2 and MLH1 identified in 1721 german families
suspected of hereditary nonpolyposis colorectal cancer Int J Cancer 2005 116 692-702
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG11
1 Rosell R Moran T Queralt C Porta R Cardenal F Camps C Majem M Lopez-Vivanco G Isla D Provencio M Insa A Massuti
B Gonzalez-Larriba J L Paz-Ares L Bover I Garcia-Campelo R Moreno M A Catot S Rolfo C Reguart N Palmero R Sanchez
JM Bastus R Mayo C Bertran- Alamillo J Molina M A Sanchez J J Taron M (2009) Screening for epidermal growth factor receptor
mutations in lung cancer N Engl J Med 361 958-967
2 Peacuterez-Soler R Chachoua A Hammond L A Rowinsky E K Huberman M Karp M Rigas J Clark G M Santabaacuterbara P Bonomi P
(2004) Determinants of Tumor Response and Survival With Erlotinib in Patients With NonndashSmall-Cell Lung Cancer Journal og Clinical
Oncology 22 16
3 Pines G Koumlstler W JYosef Yarden Department of Biological Regulation The Weizmann Institute of Science Rehovot 76100 Israel (2010)
Oncogenic mutant forms of EGFR lessons in signal transduction and targets for cancer therapy FEBSLett 584 (12) 2699ndash2706
4 ABI PRISM SnaPshot Multiplex Kit ndashProtocol and manual
5 cobasreg EGFR Mutation Test ndash User Manual
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG13
1 cobasreg 4800 HPV Test ndash Dokument č 05990343001-04SK Roche Diagnostics GmbH
2cobasreg 4800 HPV Test ndash Dokument č 05641268001-01 Roche Molecular Systems Inc
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG14
1 Nielsen SM Rhodes L Blanco I a kol 2016 Von Hippel-Lindau Disease Genetics and Role of Genetic Counseling in a Multiple Neoplasia
Syndrome J Clin Oncol 34(18)2172-2181
2 Alberta Health Services 2011 Renal cell carcinoma and genetic testing Clinical Practice Guideline GU-005
3 Chittiboina P Lonser RR 2015 Von Hippel-Lindau disease Handb Clin Neurol132139-156
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG15
1 Hereditary Cancer Solution by Sophia Genetics ndash Users guide using DNA library prep kit by Sophia genetics 48 samples
2 BRCA Hereditary Cancer MASTR Plus kit with drMID for Ilumina NGS systems ndash instructions for use
3 Crawford B Adams S B Sittler et al (2017) Multi-gene panel testing for hereditary cancer predisposition in unsolved high-risk breast and ovarian
cancer patients Breast cancer research and treatment 163(2) 383-390
4 Grissom A A Friend P J (2016) Multigene Panel Testing for Hereditary Cancer Risk Journal of the advanced practitioner in oncology 7(4) 394-
407
5 Lorans M Dow E Macrae FA Winship IM Buchanan DD (2018) Update on Hereditary Colorectal Cancer Improving the Clinical Utility of
Multigene Panel Testing Clin Colorectal Cancer 17(2)e293-e305
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG16
1 Ledermann PARP inhibitors in ovarian cancer Annals of Oncology (2016) 27 i40ndashi44
2 Koczkowska M et al Detection of somatic BRCA12 mutations in ovarian cancer - next-generation sequencing analysis of 100 cases Cancer Med
2016 Jul5(7)1640-6
3 Dougherty BA et al Biological and clinical evidence for somatic mutations in BRCA1 and BRCA2 as predictive markers for olaparib response in
high-grade serous ovarian cancers in the maintenance setting Oncotarget 2017 Jul 48(27)43653-43661
4 Maxwell KN et al BRCA locus-specific loss of heterozygosity in germline BRCA1 and BRCA2 carriers Nat Commun 2017 Aug 228(1)319
5 httpswwwagilentcomcslibrarybrochuresBrochure20Complete20solution20BRCA20MASTR20(Plus)20Dx20v1708pdf
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG17
1 MRC-Holland ndash MLPA General Protocol httpswwwmlpacom
2 Ticha I Kleibl Z Stribrna J a kol Screening for genomic rearragements in a genes in Czech high-risk breastovarian cancer patients high
proportion of population specific alterations in gene Breast Cancer Research and Treatment 2010 124 (2)337-347
3 Sluiter MD van Rensburg EJ Large genomic rearragements of the BRCA1 and BRCA2 genes review of the literature and report of a novel BRCA1
mutation Breast Cancer Research and Treatment 2011 125 325-349
Osoby spocircsobileacute modifikovať a validovať metoacutedy na Oddeleniacute lekaacuterskej genetiky
Meno a priezvisko tituly Spocircsobilosť modifikovať a validovať metoacutedy
ndash čiacuteslo položky v rozsahu akreditaacutecie
Regiacutena Lohajovaacute Behulovaacute RNDr PhD 11 až 61
Katariacutena Zaacutevodnaacute RNDr PhD 11 až 61
Ľudmila Vavrovaacute Ing PhD 11 až 61
Tomaacuteš Slamka Mgr 11 až 61
Lukaacuteš Šebest Mgr PhD 11 až 61
Aster Alemayehu RNDr PhD 11 až 61
13 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Použiteacute skratky
AGLUT ndash aglutinačnaacute reakcia
AOD ndash askorbaacutetoxidaacuteza
BRCA ndash označenie geacutenu asociovaneacuteho s dedičnou formou mamaacuternehoovariaacutelneho karcinoacutemu
CDKN2A ndash označenie geacutenu asociovaneacuteho s dedičnou formou maliacutegneho melanoacutemu
E6E7 - HPV viacuterusoveacute onkogeacuteny asociovaneacute so vznikom a progresiou Ca krčka maternice
FOTO - fotometria
GLD ndash glutamaacutetdehydrogenaacuteza
GPO ndash glycerol-3-fosfaacutet-oxidaacuteza
HPLC ndash High Performance Liquid Chromatography
HPV ndash human papillomavirus (ľudskyacute papilloma viacuterus)
CHOD ndash cholesteroloxidaacuteza
IFCC ndash International Federation for Clinical Chemistry
IMF ndash meranie fluorescencie po značeniacute buniek protilaacutetkami
KOAG ndash Coagulation Point Detection Method
KRAS ndash označenie geacutenu kt somatickeacute mutaacutecie v suacute predikatiacutevnym markerom pri metastazujuacutecom ca hrubeacuteho čreva
LATEX ndash Latex immunoassay method
MLH1 - označenie geacutenu asociovaneacuteho s dedičnou formou kolorektaacutelneho karcinoacutemu
MSH2 - označenie geacutenu asociovaneacuteho s dedičnou formou kolorektaacutelneho karcinoacutemu
NRAS ndash označenie geacutenu kt somatickeacute mutaacutecie v suacute predikatiacutevnym markerom pri metastazujuacutecom ca hrubeacuteho čreva
OHT - Oddelenie hematoloacutegie a transfuzioloacutegie
OID ndash Oddelenie imunodiagnostiky
OKB ndash Oddelenie klinickej biocheacutemie
OKIA - Oddelenie klinickej imunoloacutegie a alergoloacutegie
OKPC - Oddelenie klinickej patoloacutegie a cytoloacutegie
OLG ndash Oddelenie lekaacuterskej genetiky
PAP ndash peroxidaacuteza
PCR ndash polymeraacutezovaacute reťazovaacute reakcia
PHOTO ndash spektrofotometrickaacute metoacuteda
PLP ndash pyridoxalfosfaacutet
POD ndash peroxidaacuteza
RET ndash označenie geacutenu v dedičnej forme medulaacuterneho karcinoacutemu a syndroacutemu mnohopočetnej endokrinnej neoplaacutezie typu 2
RIA - Radio Immunoassay
RT - Real-Time
ŠPP ndash Štandardnyacute pracovnyacute postup
TPO ndash Tyreoidaacutelna peroxidaacuteza
TRACE ndash Time Resolved Amplified Cryptate Emission
12 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG9 1 Nikiforov YE thyroid carcinoma molecular pathways and therapeutic targets Modern pathology 21S37-S43 2008
2 Elisei R Ugolini C Viola D Lupi C et al BRAF V600E mutation and outcome of patients with papillary thyroid carcinoma
A 15-year median follow-up study J Clin endocrine Metab 93(10)3943-3949 2008
3 SNaPshot Multiplex Kit ndash protocol and manual Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG10
1 Brigitte Wolf Silvia Henglmueller at al Spectrum of germ-line MLH1 and MSH2 mutations in Austrian patientswith hereditary nonpolyposis
colorectal cancer The Middle European Journal of Medicine 2005 1177ndash8 269ndash277
2 Elisabeth mangold Constanze Pagenstecher et al Spectrum and frequencies of mutations in MSH2 and MLH1 identified in 1721 german families
suspected of hereditary nonpolyposis colorectal cancer Int J Cancer 2005 116 692-702
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG11
1 Rosell R Moran T Queralt C Porta R Cardenal F Camps C Majem M Lopez-Vivanco G Isla D Provencio M Insa A Massuti
B Gonzalez-Larriba J L Paz-Ares L Bover I Garcia-Campelo R Moreno M A Catot S Rolfo C Reguart N Palmero R Sanchez
JM Bastus R Mayo C Bertran- Alamillo J Molina M A Sanchez J J Taron M (2009) Screening for epidermal growth factor receptor
mutations in lung cancer N Engl J Med 361 958-967
2 Peacuterez-Soler R Chachoua A Hammond L A Rowinsky E K Huberman M Karp M Rigas J Clark G M Santabaacuterbara P Bonomi P
(2004) Determinants of Tumor Response and Survival With Erlotinib in Patients With NonndashSmall-Cell Lung Cancer Journal og Clinical
Oncology 22 16
3 Pines G Koumlstler W JYosef Yarden Department of Biological Regulation The Weizmann Institute of Science Rehovot 76100 Israel (2010)
Oncogenic mutant forms of EGFR lessons in signal transduction and targets for cancer therapy FEBSLett 584 (12) 2699ndash2706
4 ABI PRISM SnaPshot Multiplex Kit ndashProtocol and manual
5 cobasreg EGFR Mutation Test ndash User Manual
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG13
1 cobasreg 4800 HPV Test ndash Dokument č 05990343001-04SK Roche Diagnostics GmbH
2cobasreg 4800 HPV Test ndash Dokument č 05641268001-01 Roche Molecular Systems Inc
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG14
1 Nielsen SM Rhodes L Blanco I a kol 2016 Von Hippel-Lindau Disease Genetics and Role of Genetic Counseling in a Multiple Neoplasia
Syndrome J Clin Oncol 34(18)2172-2181
2 Alberta Health Services 2011 Renal cell carcinoma and genetic testing Clinical Practice Guideline GU-005
3 Chittiboina P Lonser RR 2015 Von Hippel-Lindau disease Handb Clin Neurol132139-156
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG15
1 Hereditary Cancer Solution by Sophia Genetics ndash Users guide using DNA library prep kit by Sophia genetics 48 samples
2 BRCA Hereditary Cancer MASTR Plus kit with drMID for Ilumina NGS systems ndash instructions for use
3 Crawford B Adams S B Sittler et al (2017) Multi-gene panel testing for hereditary cancer predisposition in unsolved high-risk breast and ovarian
cancer patients Breast cancer research and treatment 163(2) 383-390
4 Grissom A A Friend P J (2016) Multigene Panel Testing for Hereditary Cancer Risk Journal of the advanced practitioner in oncology 7(4) 394-
407
5 Lorans M Dow E Macrae FA Winship IM Buchanan DD (2018) Update on Hereditary Colorectal Cancer Improving the Clinical Utility of
Multigene Panel Testing Clin Colorectal Cancer 17(2)e293-e305
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG16
1 Ledermann PARP inhibitors in ovarian cancer Annals of Oncology (2016) 27 i40ndashi44
2 Koczkowska M et al Detection of somatic BRCA12 mutations in ovarian cancer - next-generation sequencing analysis of 100 cases Cancer Med
2016 Jul5(7)1640-6
3 Dougherty BA et al Biological and clinical evidence for somatic mutations in BRCA1 and BRCA2 as predictive markers for olaparib response in
high-grade serous ovarian cancers in the maintenance setting Oncotarget 2017 Jul 48(27)43653-43661
4 Maxwell KN et al BRCA locus-specific loss of heterozygosity in germline BRCA1 and BRCA2 carriers Nat Commun 2017 Aug 228(1)319
5 httpswwwagilentcomcslibrarybrochuresBrochure20Complete20solution20BRCA20MASTR20(Plus)20Dx20v1708pdf
Zoznam originaacutelnych praacutec použityacutech v ŠPP OLG17
1 MRC-Holland ndash MLPA General Protocol httpswwwmlpacom
2 Ticha I Kleibl Z Stribrna J a kol Screening for genomic rearragements in a genes in Czech high-risk breastovarian cancer patients high
proportion of population specific alterations in gene Breast Cancer Research and Treatment 2010 124 (2)337-347
3 Sluiter MD van Rensburg EJ Large genomic rearragements of the BRCA1 and BRCA2 genes review of the literature and report of a novel BRCA1
mutation Breast Cancer Research and Treatment 2011 125 325-349
Osoby spocircsobileacute modifikovať a validovať metoacutedy na Oddeleniacute lekaacuterskej genetiky
Meno a priezvisko tituly Spocircsobilosť modifikovať a validovať metoacutedy
ndash čiacuteslo položky v rozsahu akreditaacutecie
Regiacutena Lohajovaacute Behulovaacute RNDr PhD 11 až 61
Katariacutena Zaacutevodnaacute RNDr PhD 11 až 61
Ľudmila Vavrovaacute Ing PhD 11 až 61
Tomaacuteš Slamka Mgr 11 až 61
Lukaacuteš Šebest Mgr PhD 11 až 61
Aster Alemayehu RNDr PhD 11 až 61
13 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Použiteacute skratky
AGLUT ndash aglutinačnaacute reakcia
AOD ndash askorbaacutetoxidaacuteza
BRCA ndash označenie geacutenu asociovaneacuteho s dedičnou formou mamaacuternehoovariaacutelneho karcinoacutemu
CDKN2A ndash označenie geacutenu asociovaneacuteho s dedičnou formou maliacutegneho melanoacutemu
E6E7 - HPV viacuterusoveacute onkogeacuteny asociovaneacute so vznikom a progresiou Ca krčka maternice
FOTO - fotometria
GLD ndash glutamaacutetdehydrogenaacuteza
GPO ndash glycerol-3-fosfaacutet-oxidaacuteza
HPLC ndash High Performance Liquid Chromatography
HPV ndash human papillomavirus (ľudskyacute papilloma viacuterus)
CHOD ndash cholesteroloxidaacuteza
IFCC ndash International Federation for Clinical Chemistry
IMF ndash meranie fluorescencie po značeniacute buniek protilaacutetkami
KOAG ndash Coagulation Point Detection Method
KRAS ndash označenie geacutenu kt somatickeacute mutaacutecie v suacute predikatiacutevnym markerom pri metastazujuacutecom ca hrubeacuteho čreva
LATEX ndash Latex immunoassay method
MLH1 - označenie geacutenu asociovaneacuteho s dedičnou formou kolorektaacutelneho karcinoacutemu
MSH2 - označenie geacutenu asociovaneacuteho s dedičnou formou kolorektaacutelneho karcinoacutemu
NRAS ndash označenie geacutenu kt somatickeacute mutaacutecie v suacute predikatiacutevnym markerom pri metastazujuacutecom ca hrubeacuteho čreva
OHT - Oddelenie hematoloacutegie a transfuzioloacutegie
OID ndash Oddelenie imunodiagnostiky
OKB ndash Oddelenie klinickej biocheacutemie
OKIA - Oddelenie klinickej imunoloacutegie a alergoloacutegie
OKPC - Oddelenie klinickej patoloacutegie a cytoloacutegie
OLG ndash Oddelenie lekaacuterskej genetiky
PAP ndash peroxidaacuteza
PCR ndash polymeraacutezovaacute reťazovaacute reakcia
PHOTO ndash spektrofotometrickaacute metoacuteda
PLP ndash pyridoxalfosfaacutet
POD ndash peroxidaacuteza
RET ndash označenie geacutenu v dedičnej forme medulaacuterneho karcinoacutemu a syndroacutemu mnohopočetnej endokrinnej neoplaacutezie typu 2
RIA - Radio Immunoassay
RT - Real-Time
ŠPP ndash Štandardnyacute pracovnyacute postup
TPO ndash Tyreoidaacutelna peroxidaacuteza
TRACE ndash Time Resolved Amplified Cryptate Emission
13 z 13
Priacuteloha k rozhodnutiu č 152807620191 a k Osvedčeniu o akreditaacutecii č M-003 zo dňa 23042019 Priacuteloha je neoddeliteľnou suacutečasťou
uvedeneacuteho osvedčenia
Použiteacute skratky
AGLUT ndash aglutinačnaacute reakcia
AOD ndash askorbaacutetoxidaacuteza
BRCA ndash označenie geacutenu asociovaneacuteho s dedičnou formou mamaacuternehoovariaacutelneho karcinoacutemu
CDKN2A ndash označenie geacutenu asociovaneacuteho s dedičnou formou maliacutegneho melanoacutemu
E6E7 - HPV viacuterusoveacute onkogeacuteny asociovaneacute so vznikom a progresiou Ca krčka maternice
FOTO - fotometria
GLD ndash glutamaacutetdehydrogenaacuteza
GPO ndash glycerol-3-fosfaacutet-oxidaacuteza
HPLC ndash High Performance Liquid Chromatography
HPV ndash human papillomavirus (ľudskyacute papilloma viacuterus)
CHOD ndash cholesteroloxidaacuteza
IFCC ndash International Federation for Clinical Chemistry
IMF ndash meranie fluorescencie po značeniacute buniek protilaacutetkami
KOAG ndash Coagulation Point Detection Method
KRAS ndash označenie geacutenu kt somatickeacute mutaacutecie v suacute predikatiacutevnym markerom pri metastazujuacutecom ca hrubeacuteho čreva
LATEX ndash Latex immunoassay method
MLH1 - označenie geacutenu asociovaneacuteho s dedičnou formou kolorektaacutelneho karcinoacutemu
MSH2 - označenie geacutenu asociovaneacuteho s dedičnou formou kolorektaacutelneho karcinoacutemu
NRAS ndash označenie geacutenu kt somatickeacute mutaacutecie v suacute predikatiacutevnym markerom pri metastazujuacutecom ca hrubeacuteho čreva
OHT - Oddelenie hematoloacutegie a transfuzioloacutegie
OID ndash Oddelenie imunodiagnostiky
OKB ndash Oddelenie klinickej biocheacutemie
OKIA - Oddelenie klinickej imunoloacutegie a alergoloacutegie
OKPC - Oddelenie klinickej patoloacutegie a cytoloacutegie
OLG ndash Oddelenie lekaacuterskej genetiky
PAP ndash peroxidaacuteza
PCR ndash polymeraacutezovaacute reťazovaacute reakcia
PHOTO ndash spektrofotometrickaacute metoacuteda
PLP ndash pyridoxalfosfaacutet
POD ndash peroxidaacuteza
RET ndash označenie geacutenu v dedičnej forme medulaacuterneho karcinoacutemu a syndroacutemu mnohopočetnej endokrinnej neoplaacutezie typu 2
RIA - Radio Immunoassay
RT - Real-Time
ŠPP ndash Štandardnyacute pracovnyacute postup
TPO ndash Tyreoidaacutelna peroxidaacuteza
TRACE ndash Time Resolved Amplified Cryptate Emission