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Clinical Chemistry 48: 255-260, 2002;
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(Clinical Chemistry. 2002;48:255-260.)
© 2002 American Association for Clinical Chemistry, Inc.

European Concerted Action on Anticoagulation. Use of Plasma Samples to Derive International Sensitivity Index for Whole-Blood Prothrombin Time Monitors

Leon Poller1a, Michelle Keown1, Nikhil Chauhan1, Anton M.H.P. van den Besselaar2, Joyce Meeuwisse-Braun2, Armando Tripodi3, Mariagrazia Clerici3 and Jørgen Jespersen4

1 European Concerted Action on Anticoagulation (ECAA) Central Facility, School of Biological Sciences, The University of Manchester, Manchester M13 9PT, United Kingdom.

2 Haemostasis and Thrombosis Research Center, Leiden University Medical Center, 2333ZA Leiden, The Netherlands.

3 A Bianchi Bonomi, Haemophilia and Thrombosis Centre, IRCCS Maggiore Hospital, University of Milan, 20122 Milan, Italy.

4 Department for Thrombosis Research, University of Southern Denmark, and Department of Clinical Chemistry, Ribe County Hospital, DK-6700 Esbjeig, Denmark.

aAuthor for correspondence. Fax 44-161-275-5316; e-mail ecaa{at}man.ac.uk.

Background: To simplify International Sensitivity Index (ISI) calibration, the possibility of substituting fresh plasma for fresh whole-blood samples with point-of-care testing (POCT) whole-blood monitors was investigated in a three-center study of three different POCT systems.

Methods: A modified full WHO calibration procedure based on 20 healthy controls and 60 coumarin-treated patients was performed on three monitoring systems with whole-blood and plasma samples against plasma tested using the European Concerted Action on Anticoagulation (ECAA) rabbit reference plain thromboplastin and the manual prothrombin time (PT) method.

Results: With one of the three systems, the mean ISI was 1.51 for whole blood and 1.49 for plasma; with the second system, the mean ISI was 1.08 for both whole blood and plasma. With the third system, however, the difference between the mean ISI for whole blood and that for plasma was greater (1.15 and 1.01, respectively). Overall, the precision of the calibrations was less than with traditional manual plasma PT testing.

Conclusions: Provided that an appropriate calcium chloride concentration is used, the plasma PT results can be used for accurate ISI calibration of two of these three whole-blood POCT systems. Precision criteria need to be modified for POCT monitors.




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


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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]


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BMJHome page
L. Poller, M. Keown, N. Chauhan, A. M. van den Besselaar, A. Tripodi, C. Shiach, and J. Jespersen
Reliability of international normalised ratios from two point of care test systems: comparison with conventional methods
BMJ, July 3, 2003; 327(7405): 30.
[Abstract] [Full Text] [PDF]


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J. Clin. Pathol.Home page
L Poller, M Keown, N Chauhan, A M H P van den Besselaar, A Tripodi, C Shiach, and J Jespersen
European Concerted Action on Anticoagulation (ECAA). An assessment of lyophilised plasmas for ISI calibration of CoaguChek and TAS whole blood prothrombin time monitors
J. Clin. Pathol., February 1, 2003; 56(2): 114 - 119.
[Abstract] [Full Text] [PDF]


Home page
Clin. Chem.Home page
L. Poller, M. Keown, N. Chauhan, A. M.H.P. van den Besselaar, A. Tripodi, C. Shiach, and J. Jespersen
European Concerted Action on Anticoagulation. 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 Plasmas Based on Whole-Blood Equivalent PT
Clin. Chem., October 1, 2002; 48(10): 1672 - 1680.
[Abstract] [Full Text] [PDF]




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