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Clinical Chemistry 48: 1672-1680, 2002;
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(Clinical Chemistry. 2002;48:1672-1680.)
© 2002 American Association for Clinical Chemistry, Inc.

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

Leon Poller1,2a, Michelle Keown1, Nikhil Chauhan1, Anton M.H.P. van den Besselaar2,2, Armando Tripodi3,2, Caroline Shiach4,2 and Jorgen Jespersen5,2

1 ECAA Central Facility, School of Biological Sciences, The University of Manchester, Manchester M13 9PT, United Kingdom.

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

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

4 Department of Clinical Haematology, Manchester Royal Infirmary, Oxford Road, Manchester, M13 9WL Manchester, United Kingdom.

5 Department for Thrombosis Research, University of Southern Denmark and Department of Clinical Biochemistry, Ribe County Hospital, DK-6700 Esbjerg, Denmark.

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

Background: The International Sensitivity Index (ISI) calibration of whole-blood prothrombin time (PT) monitors for point-of-care testing (POCT) described by Tripodi et al. (Thromb Haemost 1993;70:921–4) has been shown to be dependable but is too complex and demanding. The use of plasma would simplify calibration of whole-blood POCT PT monitors, but important differences may exist between the ISI for whole blood and plasma calibrations.

Methods: In a 10-center calibration study of two POCT whole-blood monitoring systems (CoaguChek Mini and TAS PT-NC), we characterized the relationship between the log PT for whole blood and fresh plasma with use of single lots of test strips/cards. This relationship (linear) was used to correct the difference between the whole-blood and plasma ISI. The reliability of the correction with different lots of test strips/cards was assessed at three centers. The linear relationship was used to correct the difference in the whole-blood and plasma ISI with four other lots of TAS PT-NC cards and with two additional lots of CoaguChek Mini test strips.

Results: The correction decreased the ISI difference from 13.3% to 0.9% for the TAS PT-NC and from 5.7% to 0.6% for the CoaguChek Mini. In assessments at three centers, which included different lots of test strips/cards, the mean ISI difference was markedly decreased with the TAS PT-NC but not with the CoaguChek Mini, for which the mean ISI difference increased slightly.

Conclusions: The proposed correction resolves the discrepancy between whole-blood and fresh plasma ISI calibrations with TAS PT-NC test cards. The CoaguChek Mini systems could be calibrated without this correction.




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


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
 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. Quality Assessment of the CoaguChek Mini and TAS PT-NC Point-of-Care Whole-Blood Prothrombin Time Monitors
Clin. Chem., March 1, 2004; 50(3): 537 - 544.
[Abstract] [Full Text] [PDF]

Home page
 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]

Home page
 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]


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