International normalised ratio (INR) measured on the CoaguChek S and XS compared with the laboratory for determination of precision and accuracy

被引:39
作者
Christensen, Thomas D. [1 ,2 ]
Larsen, Torben B. [3 ]
Jensen, Claus [4 ]
Maegaard, Marianne [1 ,2 ]
Sorensen, Benny [2 ,5 ,6 ,7 ]
机构
[1] Aarhus Univ Hosp, Dept Cardiothorac & Vasc Surg, DK-8200 Aarhus N, Denmark
[2] Aarhus Univ Hosp, Inst Clin Med, DK-8200 Aarhus N, Denmark
[3] Odense Univ Hosp, Dept Biochem Pharmacol & Genet, Sect Thrombosis & Haemostasis, DK-5000 Odense, Denmark
[4] Danish IT Ctr Educ & Res, UNIC, Aarhus N, Denmark
[5] Aarhus Univ Hosp, Ctr Hemophilia & Thrombosis, Dept Clin Biochem, DK-8000 Aarhus N, Denmark
[6] Guys & St Thomas NHS Trust Fdn, Ctr Hemophilia & Thrombosis, Haemostasis Res Unit, London, England
[7] Kings Coll London, Sch Med, London WC2R 2LS, England
关键词
Coumarins; international normalised ratio; oral anticoagulant; point-of-care testing; self-management; ORAL ANTICOAGULANT-THERAPY; EXTERNAL QUALITY ASSESSMENT; HEART-VALVE REPLACEMENT; SELF-MANAGEMENT; CONTROLLED-TRIAL; MONITOR; STANDARD; METAANALYSIS; CALIBRATION; GUIDELINES;
D O I
10.1160/TH08-09-0601
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Oral anticoagulation therapy is monitored by the use of international normalised ratio (INR). Patients performing self-management estimate INR using a coagulometer, but studies have been partly flawed regarding the estimated precision and accuracy. The objective was to estimate the imprecision and accuracy for two different coagulometers (CoaguChei (R) S and XS).Twenty-four patients treated with coumarin were prospectively followed for six weeks. INR's were analyzed weekly in duplicates on both coagulometers, and compared with results from the hospital laboratory. Statistical analysis included Bland-Altman plot, 95% limits of agreement, coefficient of variance (CV), and an analysis of variance using a mixed effect model, Comparing 141 duplicate measurements (a total of 564 measurements) of INR, we found that the CoaguChek S and CoaguChek XS had a precision (CV) of 3.4% and 2.3%, respectively. Regarding analytical accuracy, the INR measurements tended to be lower on the coagulometers, and regarding diagnostic accuracy the CoaguChek S and CoaguChek XS deviated more than 15% from the laboratory measurements in 40% and 43% of the measurements, respectively. In conclusion, the precision of the coagulometers was found to be good, but only the CoaguChek XS had a precision within the predefined limit of 3%. Regarding analytical accuracy, the INR measurements tended to be lower on the coagulometers, compared to the laboratory. A large proportion of measurement of the coagulometers deviated more than 15% from the laboratory measurements. Whether this will have a clinical impact awaits further studies.
引用
收藏
页码:563 / 569
页数:7
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