トロンボプラスチン試薬の感度(ISI)による PT-INR値の変動お …

1 Vol. 5 No. 2 2010 J Cardiol Jpn Ed93 (ISI) PT-INR coaguchek -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, MD21 2 TT PT TT TT 1 PT PT PT ISI; International Sensitivity Index 1983 J Cardiol Jpn Ed 2010; 5: 93 101<Keywords> PT-INR ISI coaguchek -XS CUC-XS C+ S PT-INR PT-INR PT-INR ISI PT-INR coaguchek -XS CUC-XS 202 CUC-XS 2 C+ S CUC-XS CUC-XS ISI C+ PT-INR SD ISI C+ PT-INR PT-INR PT-INR ISI CUC-XS ISI PT-INR

2 ISI CUC-XS ISI * 257-0011 931-7 2 E-mail: 10 28 2009 11 16 J Cardiol Jpn Ed Vol. 5 No. 2 2010 94PT INR = ISIMRD % =100 TEST C+ REFERENCE CUC-XS MRD agreement rating< ; Excellent, ; very good, ; good, ; acceptable, ; marginal, ; very poorWHO PT ISI INR; International Normalized Ratio PT-INR 2 4 PT-INR PT PT PT ISI ISI PT 1A WHO ISI 5 PT-INR coaguchek -XS CUC-XS ISI ISI 202 Quick CUC-XS PT-INR C+ ISI ISI CA7000 ISI PT MNPT C+ 1715 610 55 C+ B H S R

3 PT-INR PT-INR CUC-XS 95 CI Bland-Altman bias plot MRD Mean absolute value of the Relative Deviation 1B Expanded agreement Narrow agreement 6,7 A Expanded agreement 1 PTT-INR 2 3 B Narrow agreement 1 2 3 1 C+ CUC-XS 202 1,715 C+ ISI CUC-XS ISI PT-INR C+ PT-INR CUC-XS SD 95 % CI 1 PT-INR Y= + 1N TEST REFERENCEREFERENCE PT PT 1 PT-INR(A) MRD agreement rating(B).

4 ABVol. 5 No. 2 2010 J Cardiol Jpn Ed95 PT-INR R = Y CUC-XS X C+ R 2 A MRD marginal Bland-Altman plot 2-B PT-INR 2 CUC-XS 202 610 S ISI CUC-XS ISI S CUC-XS PT-INR SD 95% CI 2 Y= Y CUC-XS X S R = MRD % excellent 3-A Bland-Altman plot 3-B PT-INR PT-INR CUC-XS 2 5 3 55 C+ 4 PT-INR 4 PT-INR By - x(x + y) /2 Bland-Altman plot: CUC-XS vs + + 2 C+ CUC-XS (A) Bland-Altman plot (B).A C+ x CUC-XS y n=1715 y= + , R = B C+ CUC-XS Bland-Altman bias plot X x+y/2, y y x 2SD PT-INR 2SD CUC-XS: + < 1 C+ CUC-XS PT-INR + < : coaguchek -XS, +: C+.

5 1 Cardiol Jpn Ed Vol. 5 No. 2 2010 96 4 PT-INR PT-INR PT-INR PTT-INR 5 PT-INR expanded agreement narrow agreement 6,7 CUC-XS C+ % expanded agreement 99 % narrow agreement 94% - x(y + x) /2 Bland-Altman plot: CUC-XS vs 3 CUC-XS (A) Bland-Altman plot (B).A x CUC-XS y n=610 y= R= CUC-XS Bland-Altman bias plot PT-INR 2SD : , CUC-XS: < 2 CUC-XS PT-INR < : coaguchek -XS, : 1012345665431001234562 Vol.

6 5 No. 2 2010 J Cardiol Jpn Ed97 PT-INR CUC-XS S Expanded agreement narrow agreement 99% 99% C+ 11 S 15% C+ 39% S 2% 4 C+ CUC-XS PT-INR PT-INR +: C+, CUC-XS: coaguchek -XS. 5 CUC-XS PT-INR CUC-XS : , CUC-XS: + + CUC-XSJ Cardiol Jpn Ed Vol. 5 No. 2 2010 98 TT 1 PT-INR 2007 PT-INR POCT coaguchek PT-INR Quick PT-INR CUC-XS CUC-XS 1994 PT-INR CUC-XS

7 C+ PT-INR CUC-XS CUC-XS CUC-XS PT PT 1983 rTF/95& CRM149S ISI = 1 ISI WHO ISI ISI/INR PT-INR 2,3 PT-INR 1 PT ISI ISI PT WHO ISI 5 1990 ISI ISI 18 ISI PT. 50% 55% ISI 20% 20% 6 CUC-XS ISI ISI ISI C+ PT-INR PT-INR 1 4 ISI 6 18 ISI C+ PT 50% Vol.

8 5 No. 2 2010 J Cardiol Jpn Ed99 PT-INR PT-INR MNPT ISI MNPT MNPT ISI ISI Local ISI 55 C+ 4 PT-INR ISI CUC-XS 8 coaguchek -XS CUC-XS coaguchek -S CUC-S 2005 Roche 2007 CUC PT-INR POCT 15 9 POCT CUC TAS PoTime Hemochon Junior CUC External Quality Assessment EQA

9 10,11 CUC-XS CUC CUC-S 9 ISI CUC-S 8,9 POCT PT-INR PT-INR TTR 12,13 QOL PT-INR EQA 3,100 PT-INR UK National External Quality Assessment Scheme NEQAS , WHO International External Quality Assessment Scheme, European National External Quality Assessment European Concerted Action on Anticoagulation ECAA POCT 3,100 70 PT-INR PT-INR 14,15 EQA POCT 16 18 CUC CUC-S EQA CUC CUC-S 6,10 POCT 11,20,21 CUC-XS 2005 ISI 8,9.

10 22 25 CUC-XS C+ PT-INR C+ ISI ISI PT ISI PT+ ISI ISI ISI PT AK ISI J Cardiol Jpn Ed Vol. 5 No. 2 2010 100 C+ C+ INR INR ISI INR C+ CUC-XS C+ Local ISI INR C+ 2013 C+ BML SRL 4 C+ ISI/INR PT-INR PT-INR ISI WHO ISI INR ISI/INR EQA INR 26 PT-INR