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Clinical Chemistry 52: 1843-1847, 2006; 10.1373/clinchem.2006.071639
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(Clinical Chemistry. 2006;52:1843-1847.)
© 2006 American Association for Clinical Chemistry, Inc.

Overview

Quality Assessment of CoaguChek Point-of-Care Prothrombin Time Monitors: Comparison of the European Community–Approved Procedure and Conventional External Quality Assessment

Leon Poller1,a, Michelle Keown1, Saied A. Ibrahim1, Felix J.M. van der Meer2, Anton M.H.P. van den Besselaar2, Armando Tripodi3, Jørgen Jespersen4 European Action on Anticoagulation, Pieter Meijer5, Cornelis Kluft5 European Concerted Action on Thrombosis

1 Faculty of Life Sciences, University of Manchester, Manchester, United Kingdom.
2 Haemostasis and Thrombosis Research Center, Leiden University Medical Center, Leiden, The Netherlands.
3 A. Bianchi Bonomi Hemophilia & Thrombosis Centre, University and Istituto di Ricovero e Cura a Carattere Scientifico Maggiore Hospital, Milan, Italy.
4 Department of Clinical Biochemistry, Ribe County Hospital in Esbjerg, Esbjerg, Denmark.
5 European Concerted Action on Thrombosis Foundation, Wassenaarseweg, Leiden, The Netherlands.

aAddress correspondence to this author at: European Action on Anticoagulation Central Facility, Faculty of Life Sciences, The University of Manchester, 3.239 Stopford Building, Oxford Road, Manchester M13 9PT, United Kingdom. Fax 44-161-275-5316; e-mail ecaa{at}manchester.ac.uk.


Abstract

Background: There is a need for dependable quality assessment (QA) of the widely used CoaguChek point-of-care testing prothrombin time monitor. By use of the prescribed set of 5 CoaguChek certified international normalized ratio (INR) QA plasmas, we compared the reliability of the immediate QA of individual monitors described in the European Community–recommended Technology Implementation Plan with conventional external QA analysis.

Methods: Experienced staff tested CoaguChek point-of-care monitors in routine use for controlling oral anticoagulant dosage at 9 Netherlands Thrombosis Service Centres. Testing was performed with both the certified CoaguChek INR for a set of 5 QA individual plasmas from the Eur Con Action on Anticoag (ECAA) and conventional external QA analysis.

Results: Patients brought 523 CoaguChek monitors to our service centers for assessment. The proportion with unsatisfactory performance indicated by a 15% deviation from the ECAA set was compared with 15% deviation from overall median INR of all CoaguChek monitors in the survey, as in conventional QA analysis. The results were similar (20.3% and 18.5%, respectively). Interlot differences of CoaguChek test strips were detected, but the incidence of unsatisfactory performance was similar with both analyses, from 6.5% to 37.5% with the certified INR method and from 5.9% to 33.3% with the overall median analysis.

Conclusions: The results validate the use of the European Action on Anticoagulation rapid single-instrument QA-specific procedure for CoaguChek users compared with the nonspecific conventional QA analysis that relies on deviation from the overall median INR.




The following articles in journals at HighWire Press have cited this article:


Home page
 Clin. Chem.Home page
S. Kitchen, D. Kitchen, I. Jennings, T. Woods, and I. Walker
Quality Assessment of CoaguChek Point-of-Care International Normalized Ratio Monitors: A Note of Caution
Clin. Chem., August 1, 2007; 53(8): 1555 - 1556.
[Full Text] [PDF]

Home page
 Clin. Chem.Home page
L. Poller, J. Jespersen, M. Keown, S. Ibrahim, and A. Tripodi
The authors of the article cited above respond:
Clin. Chem., August 1, 2007; 53(8): 1556 - 1557.
[Full Text] [PDF]

Home page
 Eur Heart JHome page
R. De Caterina, S. Husted, L. Wallentin, G. Agnelli, F. Bachmann, C. Baigent, J. Jespersen, S. D. Kristensen, G. Montalescot, A. Siegbahn, et al.
Anticoagulants in heart disease: current status and perspectives
Eur. Heart J., April 10, 2007; (2007) ehl492v1.
[Full Text] [PDF]

eLetters:

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Quality Assessment of CoaguChek Point-of-Care Prothrombin Time Monitors
Siegmund L. Braun, et al.
Clinical Chemistry Online, 7 Nov 2006 [Full text]
Comment on the article of Poller et al. in Clinical Chemistry 52:10 1843-1847 (2006)
Michael Spannagl, et al.
Clinical Chemistry Online, 5 Feb 2007 [Full text]
Re: Quality Assessment of CoaguChek Point-of-Care Prothrombin Time Monitors
Joergen Jespersen, et al.
Clinical Chemistry Online, 5 Feb 2007 [Full text]

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