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(ISI) PT-INRCoaguChek-XS Clinically Significant Differences in the PT-INR with Reagents with Different Sensitivities Comparison of CoaguChek-XS with Laboratory Method

1,* 1 2

Chikayoshi KOMATSU, MD1,*, Harukazu ISEKI, MD1, Hiromitsu SATO, MD2

1 2

TTPTTT TT1PTPTPTISI; International Sensitivity Index1983

J Cardiol Jpn Ed 2010; 5: 93 101 PT-INR ISI CoaguChek-XSCUC-XS

C+ S

PT-INRPT-INRPT-INRISIPT-INRCoaguChek-XSCUC-XS

202CUC-XS2C+SCUC-XS

CUC-XSISI1.51.7C+PT-INRSD0.26 0.21 ISI1.0 0.005 0.21C+PT-INR1.60.180.20 PT-INR 2.63.00.600.78 PT-INR ISI1.0CUC-XS ISI1.51.7

PT-INR ISICUC-XS ISI 1.0

* 257-0011 931-7 2E-mail: chi-koma@mue.biglobe.ne.jp2009102820091116

J Cardiol Jpn Ed Vol. 5 No. 2 2010 94

PTINR = ISI

MRD%=100TESTC+REFERENCECUC-XS

MRD agreement rating

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PT-INR

R = 0.940YCUC-XSXC+R2AMRD14.6%

marginalBland-Altman plot 2-BPT-INR

2CUC-XS202 610SISI0.98CUC-XSISI1.0SCUC-XSPT-INR0.005 0.28 SD95% CI0.00060.0152

Y= 1.068X-0.122YCUC-XSXSR = 0.953MRD5.0 % excellent3-ABland-Altman plot3-BPT-INRPT-INR2.62.6CUC-XS0.20.425

355C+4PT-INR4PT-INR

B

y-x

(x+y) /2

Bland-Altman plot: CUC-XS vs Thro.pl.C+A

CU

C-X

S

Thro.pl.C+

2C+ CUC-XS (A) Bland-Altman plot (B).AC+xCUC-XSyn = 1715y = 0.699x + 0.367 ,R= 0.940BC+CUC-XS Bland-Altman bias plotX x + y/2, y yx 2SDPT-INR 2SDCUC-XS: CoaguChek-XS.

y = 0.699 x + 0.367R = 0.940P < 0.0001

1 C+ CUC-XS PT-INR

CUC-XS Thro.pl.C+

1.01.5 1.39 0.12 1.55 0.20 0.17 0.15

1.62.0 1.78 0.14 2.02 0.23 0.24 0.17

2.12.6 2.27 0.15 2.61 0.30 0.34 0.28

2.73.0 2.80 0.09 3.42 0.26 0.61 0.23

3.1< 3.61 0.52 4.60 0.73 0.98 0.31

CUC-XS: CoaguChek-XS, Thro.pl.C+: C+ .

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J Cardiol Jpn Ed Vol. 5 No. 2 2010 96

2.1 0.422.1 0.482.0 0.452.1 0.45

43.8%PT-INRPT-INRPT-INR1.91 0.532.06

0.51%PTT-INR

5PT-INR expanded agreement narrow agreement 6,7CUC-XSC+ 59.3% 78.3 %expanded agreement99 %narrow agreement94%

A B

CU

C-X

S

Thro.rel.S

y-x

(y+x) /2

Bland-Altman plot: CUC-XS vs Thro.rel.S

3 CUC-XS (A) Bland-Altman plot (B).AxCUC-XSyn = 610y = 1.068x 0.122R = 0.953.BCUC-XS Bland-Altman bias plotPT-INR 2SDThro.rel.S:, CUC-XS: CoaguChek-XS.

y = 1.068x 0.122R = 0.953P < 0.0001

2 CUC-XS PT-INR

CUC-XS Thro.rel.S

1.01.5 1.38 0.13 1.41 0.17 0.05 0.13

1.62.0 1.79 0.13 1.81 0.15 0.03 0.10

2.12.6 2.25 0.15 2.19 0.17 0.06 0.14

2.73.0 2.84 0.12 2.70 0.20 0.14 0.17

3.1< 3.71 0.94 3.31 0.65 0.40 0.34

CUC-XS: CoaguChek-XS, Thro.rel.S: S.

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PT-INR

CUC-XSS72.0%93.9%Expanded agreementnarrow agreement99%99%0.5

C+11S0.2%15%C+39%S2%

4C+ CUC-XS PT-INR 1.6 0.2 PT-INR 3.0 0.6-1.0Thro.pl.C+:C+, CUC-XS: CoaguChek-XS.

5 CUC-XS PT-INR 2.6 2.6CUC-XSThro.rel.S:, CUC-XS: CoaguChek-XS.

Thro.pl.C+CUC-XS

CUC-XS

Thro.pl.C+

CUC-XS

Thro.rel.S

Thro.rel.SCUC-XS

J Cardiol Jpn Ed Vol. 5 No. 2 2010 98

TT1PT-INR2007PT-INRPOCTCoaguChekPT-INR

QuickPT-INRCUC-XSCUC-XS1994PT-INRCUC-XSC+PT-INRCUC-XS0.26CUC-XS

CUC-XSPT PT1983 rTF/95&

CRM149SISI = 1ISIWHOISIISI/INRPT-INR2,3 PT-INR1PTISIISIPTWHOISI0.91.71.051990ISI 2.01.0ISI 0.91.718 ISI 1.511.7PT. 50%55%ISI 1.020%20%6CUC-XSISI 1.01ISI 0.980.005ISI 1.77C+0.26 0.21PT-INR 1.60.18PT-INR 3.00.60.8

14ISI

6 18 ISI1.6C+PT 50%

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PT-INR

PT-INRMNPTISIMNPTMNPTISIISILocal ISI 55C+4PT-INRISICUC-XS8

CoaguChek-XSCUC-XSCoaguChek-SCUC-S2005Roche2007CUCPT-INRPOCT159POCT CUCTASPoTimeHemochon Junior CUCExternal Quality Assessment

EQA10,11CUC-XSCUCCUC-S9ISI1.0CUC-S8,9POCTPT-INRPT-INR

TTR12,13QOL

PT-INREQA

3,100 PT-INR UK National External Quality Assessment SchemeNEQAS, WHOInternational External Quality Assessment Scheme, European National External Quality Assessment European Concerted Action on AnticoagulationECAAPOCT3,10070PT-INRPT-INR 14,15EQAPOCT1618CUCCUC-SEQACUCCUC-S6,10POCT11,20,21CUC-XS2005 ISI1.08,9,2225

CUC-XSC+PT-INRC+ISI1.77 ISI0.98 PTISI1.59PT+ISI1.03ISIISIPTAKISI

J Cardiol Jpn Ed Vol. 5 No. 2 2010 100

C+0.21C+INR 1.50.100.2INR 1.53.00.5ISIINR 3.0C+CUC-XSC+Local ISIINRC+2013C+BMLSRL4C+

ISI/INRPT-INRPT-INRISIWHOISI 1.51.7INRISI/INREQAINR26PT-INRC+1.62.6CUC-XS1.42.22.03.01.82.670INR 2.03.01850%ISI 1.51.7

6PT-INR

2730PT-INRISI

PT-INRISICUC-XSCUC-XS

BML

, , . . 2002; 8: 883886.WHO Expert Committee on Biological Standardization. Thirty-third Report: Technical report series No. 687. Gene-va: World Health Organization; 1983. p. 81105.ICSH/ICTH Recommendation for reporting prothrombin time in oral anticoagulant control. Thromb Haemost 1985; 53: 155156.. . 2002; 50: 779785.WHO expert committee on biological standardization. For-ty-eighth Report: Technical report series No.889.Geneva: World Health Organization 1999. p. 6493.Douketis JD, Lane A, Milne J, Ginsberg JS. Accuracy of a portable international normalization ratio monitor in outpa-tients receiving long-term oral anticoagulant therapy: Com-parison with a laboratory reference standard using clinically relevant criteria for agreement. Thromb Res 1998; 92: 1117.Anderson DR, Harrison L, Hirsh J. Evaluation of a portable prothrombin time monitor for home use by patients who re-quire long-term oral anticoagulant therapy. Arch Intern Med 1993; 153: 14411447.Plesch W, Wolf T, Breitenbeck N, Dikkeschei LD, Cer-

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vero A, Perez PL, van den Besselaar AMHP. Results of the performance verification of the CoaguChek XS sys-tem. Thromb Res 2008; 123: 381389.Braun S,Watzke H, Hasenkam M, Schwab M, Wolf T, Dovifat C,Vller H. Performance evaluation fo the new CoaguChek XS system compared with the estab-lished CoaguChek system by patients experienced in INR-self management. Thromb Haemost 2007; 97: 310314.Moore GW, Henley A, Cotton SS, Tugnait S, Rangara-jan S. Clinically significant differences between point-of-care analysers and a standard analyser for monitoring the International Normalized Ratio in oral anticoagu-lant therapy: a multi-instrument evaluation in a hospital outpatient setting. Blood Coagul Fibrinolysis 2007; 18: 287292.Poller L, Keown M, Chauhan N, van den Besselaar AMHP, Tripodi A, Shiach C, Jespersen J. European Concerted Action on Anticoagulation. Correction of displayed international normalized ratio on two point-of-care test whole-blood prothrombin time monitors (CoaguChek Mini and TAS PT-NC) by independent in-ternational sensitivity index calibration. Brit J Haematol 2003; 122: 944949.Heneghan C, Alonso-Coello P, Garcia-alamino JM, Per-era R, Meats E, Glasziou P. Self-monitoring of oral an-ticoagulation: a systematic review and meta-analysis. Lancet 2006; 367: 404411.Eits T, Schenk S, Feitzsche D, Bairaktaris A, Wagner O, Koertke H, Koerfer R. International normalized ratio self-management lowers the risk of thromboembolic events after prothetic heart valve replacement. Ann Tho-rac Surg 2008; 85: 949954., , , , , , , , , , , , , , , . PT, TT Local Standardization . 1997: 45: 321327.. ISI/INR . 1990; 31: 769775.. INR CoaguChek XS. 2008; 23: 218223., , , , , . warfarin . 2008; 61: 530532., , , , . PT-INR CoaguChek XS. 2009; 33: 8991.. . 2007; 55: 465469.Poller l, Keown M, Chauhan N, van den Besselaar

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AMNP, Tripodi A, Shiach C, Jespersen J. European con-certed action on anticoagulation. Quality assessment of the CoaguChek Mini and TAS PT-NC point-of-care whole-blood prothrombin time monitors. Clin Chem 2004; 50: 537544.Poller L, Keown M, Chauhan N, van den Besselaar AMHP, Tripodi A, Shiach C, Jespersen J. European con-certed action on anticoagulation (ECAA). Evaluation of a method for international sensitivity index calibration of two point-of- care prothrombin time (PT) monitoring systems (CoaguChek Mini and TAS PT-NC) with fresh pPlasmas based on whole blood eqivalent PT. Clin Chem 2002; 48: 16721680.Berznicki LR, Jackson SL, Peterson GM, Jeffrey EC, Mars-den KA, Jupe DM. Accuracy and clinical utility of the Coa-guChek XS portable international normalised ratio monitor in a pilot study of warfarin home-monitoring. J Clini Pathol 2007; 60: 311314.Bauman ME, Black KL, Massicotte MP, Bauman ML, Kuhle S, Howlett-Clyne S, Cembrowski GS, Bajzar L. Ac-curacy of the CoaguChek XS for point-of-care international normalized ratio(INR) measurement in children requiring warfarin.Thromb Haemost 2008; 99: 10971103.Leichsenring L, Plesch W, Unkrig V, Kitchen S, Kitchen DP, Maclean R, Dikkeschei B, van den Besselaar AMHP. Multicentre ISI assignment and calibration of the INR mea-suring range of a new point-of-care system designed for home monitoring of oral anticoagulation therapy. Thromb Haemost 2007; 97: 856861.Plesch W, van den Besselaar AMHP. Validation of the inter-national normalized ratio (INR) in a new point-of-care sys-tem designed for home monitoring of oral anticoagulation therapy. Int J Lab Hematol 2007; 31: 2025. Kitchen S, Kitchen D, Jennings I, Woods T, Walker I. Qual-ity assessment of CoaguChek point-of-care international normalized ratio monitors: a note of caution. Clin Chem 2007; 53: 15551556.Yamaguchi T. Optimal intensity of warfarin therapy for secondary prevention of stroke in patients with nonvalvular atrial fibrillation: A multicenter, prospective, randomized trial.Japanese nonvalvular atrial fibrillation-embolism sec-ondary prevention cooperative study group. Stroke 2000; 31: 817821.Yasaka M, Minematsu K, Yamaguchi T. Optimal intensity of international normalized ratio in warfarin therapy for secondary prevention of stroke in patients with non-valvu-lar atrial fibrillation. Intern Med 2001; 40: 11811188., . INR . 2001; 2: 17. , . . 2008; 2: 186194.

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