A national field study of quality assessment of CoaguChek point-of-care testing prothrombin time monitors

被引：32

作者：

Meijer, Piet ^{[1
]}

Kluft, Cornelis ^{[1
]}

Poller, Leon ^{[1
]}

van der Meer, Felix J. M. ^{[1
]}

Keown, Michelle ^{[1
]}

Ibrahim, Saied ^{[1
]}

van den Besselaar, Anton M. H. P. ^{[1
]}

Tripodi, Armando ^{[1
]}

Jespersen, Jorgen ^{[1
]}

机构：

[1] Univ Manchester, Fac Life Sci, EAA Cent Facil, Manchester M13 9PT, Lancs, England

来源：

AMERICAN JOURNAL OF CLINICAL PATHOLOGY | 2006年 / 126卷 / 05期

关键词：

quality assessment; CoaguChek monitors; prothrombin time; significant deviation;

D O I：

10.1309/6Q8DY5J1THA8BQG3

中图分类号：

R36 [病理学];

学科分类号：

100104 ;

摘要：

A system for quality assessment (QA) of the CoaguChek (Roche Diagnostics, Mannheim, Germany) point-of-care testing prothrombin time monitor has been developed by the European Concerted Action on Anticoagulation. Hitherto there has not been an adequate rapid method for CoaguChek QA. Sets of 5 certified international normalized ratio (INR) plasma samples were tested on 539 CoaguChek monitors by experienced staff at 9 Netherlands Thrombosis Centers and results compared with certified INR. A 15% or more deviation has been classified as significant deviation. Overall mean and certified INR values were similar, but 20.3% of participants showed a 15% or more deviation from the certified INR on at least I of the 5 QA plasma samples. Statistically significant differences in results with different lots of CoaguChek test strips were found. There is need for large scale QA of CoaguChek monitors. The importance of the 5 CoaguChek certified INR QA plasma samples being tested on a single occasion is demonstrated.

引用

页码：756 / 761

页数：6

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