protocol uk

8/11/2019 Protocol Uk

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PROTOCOL FOR THE DETERMINATION OF THE TESTS OF CONFIRMATIONESR ANALYSER : MICROSED-SYSTEM.

1. INTRODUCTION

1.1 Before beginning the tests, it recommends to attentively read all the attached documents and particularly the documents ICSH recommendations for measurement of erythrocytesedimentation rate, NCCLS document H !"# and $H%&LBS&'#.1 recommendation for standardi(ation, safety and )uality control of erythrocyte sedimentation rate.

1. *he tool +IC -sed!System is a small analyser that directly measures the sedimentation fromthe collecting tube /ith a system of revelation to infrared rays to a /avelength of '%% nm.

1.# *he results are given by an e0trapolation on a curve dra/n by a correlation, performed in thethree different laboratories, among the instrument and the standard system $estergren.

1. Besides the final result is compensated to a temperature of reference to 123 in accordance /iththe +anley table. It is necessary to do this because during the analysis the temperature isal/ays chec4ed and finally correlated into the right degree provided from +anley.

1.5 *he technical characteristics of the +IC -sed!System are visible to page. # of this document.

2. TESTS OF EVALUATION

2.1 Correl !"o# $e!%ee# MICRO&e'-S(&!e) #' &! #' r' *e&!er+re# )e!,o'.2.2 Te&! or !,e e l/ !"o# o !,e 0o) e#& !"o# o !,e !e) er !/re.2. Te&! or !,e e l/ !"o# o !,e /!o) !"0 0o) e#& !"o# "# 0 &e o r" !"o# o !,e r !"o

$loo'30"!r !e.2.4 Te&! o re ro'/0"$"l"!( .2.5 6/ l"!( 0o#!rol !,ro/+, !,e e) lo()e#! o !,e ,e) !olo+( 0o#!rol Pre0"&"o#-R !e

MATERIALS #' METHODS

#.1 N3 # analysers +IC -sed!System.#. N3 # mi0er -*-+I6.#.# N3 #%%! %% pipettes $estergren#. N3 # 7its of hematology controls 89recision! ate :#.5 N3 #%%! %% vacuum tubes ;5mm.#.> N3 # laboratories.

4 CHARACTERISTICS OF THE MATERIALS

.1 *he +IC -sed!System is supplied by the Company


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.# 9ipettes $


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MICROsed_System

TECHNICAL SPECIFICATIONS

Area of application !lood sedimentation rate analysis

Instr"ment si#e $ei%&t 1'( mm)idt& 1*( mmDept& 1(( mm

)ei%&t a+o"t (., -%olta%e /0T/RNA 2O)/R SU22 3 4'( 5OR 11( 6 A.C. 7(89(

$:/S. o"tp"t 14 AC (.; ( 4 mmRes"lts resol"tion E 8 > 1 mm

!lood draF leGel acceptancefrom normal E ' mm 8 > 1( mm

Display CD '( 0 4 )IT$ !ACH> I $TINInterface RS 4?4 C OR 2RINT/R

Memory * H RAM ?4 H /2ROM

SoftFare Inte%rated accordin% to softFare Gersion

Conformity I/C 1(1(>1 R/ U ATIONSDirectiGes on electroma%netic compati+ility*,8??98//C.DIR/CTI / /N ;?84? O) O TA /.

#


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7 POSITIONIN8 OF THE APPARATUSES OF MEASURE

=.1 .1 *he test must have done in the three different laboratories /ith three different analysers of thesame type, but employing him&it same material for the standard method $estergren.

>. Since the +icrosed brings the values to 123, the ideal temperature of the laboratory it /ill haveto be of %3C. or different temperatures it /ill is necessary to convert to 123 the value$estergren using the chart attached to the document.

>.# *he tool has the tendency to get overheated himself, if left turned on for long time, accordinglythe inside temperature to the tool could gro/ also of degrees in comparison to the temperatureenvironment. or this reason it advises to turn on the tool Gust before to ma4e the analysis.

>. 9ipettes $estergren of the type 8$estergren 9ipettes acuette %%: distributed by ;reiner?"ustria@ provided of special rac4, could facilitate the test for their practicality of use.

>.5 In lac4 of them, preferably use pipettes in glass /ith diameter .55 ++. perfectly /ashed anddry.

>.= Since the tool has only 1% channels, if you /ant do more tests /ith the same blood it isadvisable to employ 1% champions every day.

>.> *o number the samples and to insert them into the mi0er -*-+I6 using formality and/ith speed %.

>.2 "fter 5 minutes, to the acoustic signal of the agitator, push the pulsating Stop to stop the-*-+I6.

>.' +ove )uic4ly the samples to the +IC -sed maintaining the increasing order.>.'1 "fter #% minutes, transcribe the results on a sheet close to the number of the sample.>.' 9ut bac4 the samples on the agitator leave them sha4e for 5 minutes.

>.'# "t the e0pired time, move every samples to every test!tube 1 0 =% and )uic4ly fill the pipette $estergren ?loading the laboratory timer to =% minutes@.>.' "fter =% minutes you must )uic4ly read the results that /ill be mar4ed on the sheet close to

the correspondent number of the sample.>.'5 or a correct reading of the $estergren method, read the level in correspondence to the

tallest concentration of red cell.>.'= uring the reading avoid to ma4e influence from the values dra/n by the previous

automatic method.>.'> If the temperature environment is more than %3, the value $estergren /ill have to be

correct to 123C.>.'2 inish the test /hen you reach 1%% samples.

>.'' Insert the data in a spreadsheet, setting on the a0le 6, the results of the method $estergrenand on the a0le , those got /ith the +IC -sed!System.

>.1%%


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TEST FOR THE EVALUATION OF THE COMPENSATION IN TEMPERATURE.

2.1 irst of all it is necessary to have conditioned room or in lac4 of it, a thermostatic cell.2. If it is possible start /ith the thermostatic cell to %3.2.# *he samples Gust /ithdra/n, agitator -*-+I6 and analyser are set in the thermostatic cell

and left around % minutes /ith mi0ing samples.2. "fter this time, transfer the samples to the analyser provided of printer.2.5 "t the end of the analysis, e0tract the samples and maintaining the same order, transfer them to

the mi0er for 5 minutes, and remember to disable the conversion of the temperature on the+IC -sed.

2.= 9ut bac4 the samples on the analyser, to get the analyses to the environmental temperature of%3

2.> "t the end of the analysis, re!select the conversion of the temperature on the tool, cross againthe same samples on the agitator and lift the temperature of the thermostatic cell of 5 degrees.

2.2 "fter around % minutes, /hen the samples, tools and temperature of the cell are stabilised tothe ne/ temperature you could analy(e the samples.

2.' epeat the points >.2, >.', >.1%, >.11 up to the environmental temperature of #53C.2.1% *he final general results /ill be therefore reported values to the temperatures of

%, 5,#%,#53C /ith the respective values converted to 123C.2.11 *he values can be brought on a graph of the type in enclosure to this document.

; TEST FOR THE VERIFICATION OF THE AUTOMATIC COMPENSATION IN CASEOF VARIATION OF THE VOLUME OF


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'.> "fter accurate mi0ing, transfer shares of 1.1, 1. , 1.# and 1. ml in respective *ubes ;


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C-NCLDSI-NA

*he results of these tests can be published on the maga(ines of the sector behind validation of


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/02 ANATION OR T$/ US/ O T$/ T/M2/RATUR/ CON /RSION C$ART O T$/ /SR

MAHIN R/ /R/NC/ TO JTA! / O T/M2/RATUR/S CON /RSIONK T$/ A U/S O/SR /T ROM A D/T/RMIN/D M/T$OD CAN !/ CORR/CT/D ROM T$//N IRONM/NTA T/M2/RATUR/ TO T$/ T/M2/RATUR/ O 1*=C.

The choice of the 18 Cs is defined by MANLEY according to the studies made to correlated thevariations of the E ! varying the e"ternal them#erature$The motivations of the variation are due to the diminution of the stringiness of the #lasma %hen thethem#erature increase$This variation of the data can cause a lot of confusion on the inter#retation of the data of this test&above all %hen you #ass from a traditional method 'estergren to another method in %hich thecom#ensation of the tem#erature is active$Thin to no% the determination of the E ! %ith the method 'estergren had to be #erforms inenvironments #rovided of conditioned air if you %anted get the re#rducible results of a #atient for one day all other$ Today this is not necessary anymore than(s to the so#histicated analysers able

to measure the sedimentation %ith an a##ro"imation of ) * + 1 mms and to automatically convertthe result to 18 from the tem#erature environment$

,o% to use the chart-

.f you made a determination at an environmental them#erature %ith a determined method /for es$'estergren0& annotate the tem#erature in #ro"imity of the e"ecution og the analysis& thereforere#orting it to the chart of conversion& loo( for the value gotten by the test in the column /10$No% starting from the column in %hich the is enclosed the annotated tem#erature& go do%n u# tocross %ith the ori ontal line of the found value$The datum found in the intersection bet%een the column of the tem#erature and the ori ontal of the value to the tem#erature environment& and it is the re#orted correct value to 18C$

2or e"am#le a value of 83 mm*hs 'estergren to the tem#erature of 43C corres#onds to a valueof 58 mm*hs to 18C$

2


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TA! / O T/M2/RATUR/ CON /RSION 5MAN /3TA! /6

'


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1 6 4 7 5 9 8 :E ! ;*< 1 $4 1 $7 +

18$9C18$8 + 61$6 61$4 + 64$9 64$8 + 6 $6 6 $4 + 68$9 68$8 + 41$6 = 41$4 C TEM>

?AL@E1 6 1 1 1 1 1 1 16 4 6 6 6 6 6 6 64 7 4 4 4 4 4 4 47 5 7 7 7 7 4 4 45 5 5 5 5 7 4 4

9 5 5 7 79 8 9 9 9 5 58 : 8 8 8 9 5 5: 13 : : 8 9 9

13 11 13 13 : 8 911 16 11 11 13 : 8 9 916 14 16 16 11 13 : 8 814 17 14 14 16 11 13 8 8

17 15 17 17 14 16 13 : :15 1 15 15 17 14 11 13 131 19 1 1 15 14 11 13 1319 1: 19 19 15 17 16 11 1118 63 18 18 1 17 14 11 111: 61 1: 1: 19 1 17 16 1663 66 61 63 18 1 17 14 1461 67 66 61 1: 19 15 14 1466 67 64 66 63 18 1 17 1764 65 64 66 63 18 19 15 1567 69 67 64 61 1: 19 15 1565 68 65 67 66 63 18 1 1

6 6: 69 65 64 61 1: 19 1969 43 68 6 67 66 1: 19 1968 41 6: 69 65 64 63 18 186: 46 43 68 6 64 61 1: 1:43 44 41 6: 69 67 66 1: 1:41 47 46 43 68 65 64 63 6346 45 46 41 68 6 64 61 6144 4 47 46 6: 69 67 61 6147 48 45 44 43 68 65 66 6645 4: 4 47 41 68 6 64 644 73 49 45 46 6: 69 64 6449 71 48 4 44 43 69 67 6748 76 73 49 47 41 68 65 654: 74 73 48 45 46 6: 6 673 77 71 4: 45 44 6: 6 671 75 76 73 4 47 43 69 6976 7 74 71 49 47 41 68 6874 79 77 76 48 45 46 68 6877 7: 75 74 4: 4 44 6: 6:75 53 7 77 73 49 44 43 437 51 79 75 71 48 47 43 4379 56 78 7 76 48 47 41 4178 54 53 79 74 4: 4 46 46

7: 57 53 78 77 73 4 44 4453 55 56 7: 75 71 49 44 4451 5 54 53 7 76 48 47 47

1%


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56 59 57 53 79 74 4: 45 4554 5: 55 56 78 77 73 4 457 3 5 54 78 77 73 49 4955 1 58 57 7: 75 71 49 495 6 58 57 53 7 76 48 4859 4 5: 55 51 79 74 4: 4:58 7 3 5 56 78 77 73 735: 5 1 58 54 7: 77 73 73

3 6 5: 57 53 75 71 711 8 4 5: 55 51 7 76 766 : 7 3 5 51 79 74 744 93 5 1 59 56 78 77 777 91 6 58 54 7: 77 775 96 9 4 58 57 53 75 75

94 8 7 3 55 51 7 79 97 : 5 1 5 51 79 798 95 93 6 59 56 79 79

: 9 96 9 6 58 54 78 7893 98 96 8 4 5: 57 7: 7:91 9: 94 : 7 3 55 53 5396 83 97 93 5 1 5 53 5394 81 95 91 6 59 51 5197 86 9 96 9 4 58 56 5695 84 99 94 8 7 5: 54 549 87 98 97 : 5 5: 57 5799 85 83 95 93 3 55 5598 8 81 9 91 9 1 5 59: 88 86 99 96 9 6 59 5983 8: 84 98 94 8 4 58 5881 :3 87 9: 97 : 7 5: 5:86 :1 85 83 95 93 5 3 384 :6 8 81 9 91 1 187 :4 89 86 99 96 9 1 185 :7 88 84 98 94 8 6 68 :5 8: 87 9: 97 : 4 489 : :3 85 83 95 93 7 788 :9 :1 8 81 9 91 5 58: :8 :6 89 86 99 96:3 133 :4 88 84 98 94 9 9:1 131 :7 8: 87 9: 97 8 8

:6 136 :5 :3 85 83 97 : ::4 134 : :1 8 81 95 93 93:7 137 :9 :6 89 86 9 91 91:5 135 :8 :4 89 84 99 96 96: 13 :: :7 88 84 98 94 94:9 139 133 :5 8: 87 9: 97 97:8 138 131 : :3 85 83 97 97:: 13: 136 :9 :1 8 81 95 95

133 113 134 :8 :6 89 86 9 9131 111 137 :: :4 88 84 99 99136 116 135 133 :7 8: 87 98 98134 114 13 136 :5 :3 85 9: 9:

137 117 139 134 : :1 8 83 83135 115 138 137 :9 :6 89 81 8113 11 13: 135 :8 :4 88 86 86

11


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139 119 113 13 :: :7 88 84 84138 118 111 139 133 :5 8: 87 8713: 11: 116 138 131 :5 :3 8 8113 163 114 13: 136 : :1 8 8111 161 117 113 134 :9 :6 89 89116 166 115 111 137 :8 :4 88 88114 164 11 116 135 :: :7 8: 8:117 167 119 114 13 133 :5 :3 :3115 165 118 117 139 131 : :1 :111 16 11: 115 138 136 :9 :6 :6119 169 163 11 13: 134 :8 :4 :4118 168 161 119 113 137 :: :7 :711: 16: 166 118 111 135 :: :5 :5163 143 164 11: 116 13 133 :5 :5161 141 167 163 116 13 131 : :166 146 165 163 114 139 136 :9 :9164 144 16 161 117 138 134 :9 :9

167 147 169 161 115 13: 137 :8 :8165 145 168 166 115 113 135 :: ::16 14 16: 164 11 111 135 133 133169 149 143 167 119 116 13 131 131168 148 141 165 118 114 139 131 13116: 14: 146 16 11: 117 138 136 136143 173 144 169 163 115 13: 134 134141 171 147 168 161 11 113 137 137146 174 145 16: 166 119 113 135 135144 177 14 16: 164 118 111 13 13147 175 149 143 167 11: 116 139 139145 17 148 141 165 11: 114 139 13914 179 14: 146 16 163 117 138 138149 178 173 144 169 161 115 13: 13:148 17: 171 147 168 166 11 113 11314: 153 176 145 16: 164 119 113 113173 151 174 14 16: 167 118 111 111

cdc correla ione

1

la+>1 )ester%ren8Monitor>S

y L 1C(?;7A > 1C?79;R L (C,**'

3

63

73

3

83

133

163

173

1 3

3 53 133 153

)ester%ren

M o n i t o r > S


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%estergren Monitor+

19 1563 19

5 574 5573 4:15 1513 131 1116 :

8 9386 :616 1717 1713 858 56

6 615 1965 6819 1:8 :757 7975 717 7343 6

147 1683 9748 47

5 48 89

46 6:17 17

756 3

8 819 171 17

6 66 6

13 :6

77 784 4617 1396 9:5 547 6593 811 171 1996

76 6

546 41

8 13

1#


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13 1498 89

137 13553 5448 463 1915 18

587 8:88 :415 14

816 1483 9853 5163 1

9 975 798 8456 7553 7:78 7

5 543 6:48 45

/SR sta+ility after collection#atient time after collection

n 3$5 h 1 h 1$5 h 6 h 6$5 h

1 7 5 5 56 4 4 4 4 44 14 14 17 15 157 14 14 14 14 145 6: 43 41 46 46

55 5 55 59 59

1


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evaluation of E ! decreasing after collection$&E-'(() sam*!es stored at room tem*erat+re # .C"%

sam#le n collection a$t$6 C a$t$ 6 $6C a$t$ 6 $4C$ a$t$6 $6C a$t$65C$ a$t$65C$ a$t$65C$h8 h13 h16 h15 h19 h61 h67 h8

mm/h mm/h mm/h mm/h mm/h mm/h mm/h mm/h

1 73 44 69 61 1: 15 86 5: 59 79 77 74 4 444 1 1 14 16 16 13 87 13 8 9 9 5

5 66 63 1 15 14 16 8

15

/SR sta+ility after collection

3

13

63

43

73

53

3

3$5 h 1 h 1$5 h 6 h 6$5 h

time &o"rs

m m 8 &

erie1

erie6

erie4

erie7

erie5

erie

erie9


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MICROSED TEMPERATURE CORRECTION TEST

sam#le 15&5C 1:&5C 64C 69$5C 46&5C 4 &5C1 5 5 9 8 13 measure1 5 5 Correction to 1*= C

6 16 16 17 1 1: 66 measure6 14 16 14 11 16 17 Correction to 1*= C

4 1 1 63 65 69 6: measure4 19 1 18 18 1: 1: Correction to 1*= C

7 16 11 13 17 15 1 measure7 14 11 : 11 13 13 Correction to 1*= C

1=

3

13

63

43

73

53

3

93

mm*hh8

mm*hh13

mm*hh16

mm*hh15

mm*hh19

mm*hh61

mm*hh67

mm*hh8

erie1erie6

erie4

erie7

erie5

erie


17/17

5 17 17 17 17 19 61 measure5 15 17 14 16 16 14 Correction to 1*= C

44 47 4 7 53 54 measure47 44 46 47 44 4 Correction to 1*= C

9 4 4 7 5 9 8 measure9 7 4 7 7 5 5 Correction to 1*= C

8 16 14 14 18 18 1: measure8 14 14 14 14 11 16 Correction to 1*= C

: 8 8 : 16 9 1 measure: : 8 8 9 : 13 Correction to 1*= C

1>

MICROS/D tem p. Corre ction te s t

3

13

63

43

73

53

83

15&5C 1:&5C 64C 69$5C 46&5C 48&5C

temperat"re

s e

d > r a

t e

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