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 Poller, Michelle Keown, Nikhil Chauhan, Anton M H P Van den Besselaar, Armando Tripodi, Caroline Shiach, Jorgen Jespersen

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish
Pages (from-to)1672-1680
Number of pages9
JournalClinical Chemistry
Volume48
Issue number10
Publication statusPublished - Oct 1 2002

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Point-of-Care Systems
Prothrombin Time
Prothrombin
Calibration
Blood
Plasmas
Monitoring
Testing

ASJC Scopus subject areas

  • Clinical Biochemistry

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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. / Poller, Leon; Keown, Michelle; Chauhan, Nikhil; Van den Besselaar, Anton M H P; Tripodi, Armando; Shiach, Caroline; Jespersen, Jorgen.

In: Clinical Chemistry, Vol. 48, No. 10, 01.10.2002, p. 1672-1680.

Research output: Contribution to journalArticle

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abstract = "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.",
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AU - Poller, Leon

AU - Keown, Michelle

AU - Chauhan, Nikhil

AU - Van den Besselaar, Anton M H P

AU - Tripodi, Armando

AU - Shiach, Caroline

AU - Jespersen, Jorgen

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