European concerted action on anticoagulation: Minimum numbers of lyophilized plasma samples for ISI calibration of CoaguChek and TAS point-of-care whole blood prothrombin time monitors

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

Research output: Contribution to journalArticle

Abstract

International sensitivity index (ISI) calibration of whole blood prothrombin time (PT) monitors is too complex. We previously simplified the method by using European Concerted Action on Anticoagulation (ECAA) lyophilized plasma samples with the TAS PT-NC (Bayer AG, Leverkusen, Germany) and the CoaguChek Mini (Roche Diagnostics, Mannheim, Germany) whole blood PT monitoring systems. The TAS PT-NC required a correction derived from the line of equivalence. Monte Carlo bootstrap analysis of reducing numbers of test samples was performed with both systems. Plasma samples from patients receiving coumarin (coumarin samples), healthy subjects (normal samples), and plasma samples artificially depleted of coagulation factors were used. With the TAS PT-NC, 20 coumarin samples or 20 artificially depleted samples with 7 normal samples gave reliable ISI and international normalized ratio and satisfactory precision. With the CoaguChek Mini, 30 coumarin and 10 normal samples were required. Simplification of ISI calibration of the 2 monitoring systems is possible using fewer ECAA lyophilized plasma samples than the 80 required according to the World Health Organization guidelines for conventional PT systems and previously recommended for fresh plasma samples tested on the same 2 monitoring systems.

Original languageEnglish
Pages (from-to)232-240
Number of pages9
JournalAmerican Journal of Clinical Pathology
Volume119
Issue number2
DOIs
Publication statusPublished - Feb 1 2003

Fingerprint

Point-of-Care Systems
Prothrombin Time
Calibration
Germany
Blood Coagulation Factors
International Normalized Ratio
Healthy Volunteers
Guidelines
coumarin

Keywords

  • INR
  • International normalized ratio
  • International sensitivity index
  • ISI calibration
  • Lyophilized plasma
  • Minimum numbers
  • POC PT monitors
  • Point-of-care
  • Prothrombin time
  • PT

ASJC Scopus subject areas

  • Pathology and Forensic Medicine

Cite this

European concerted action on anticoagulation : Minimum numbers of lyophilized plasma samples for ISI calibration of CoaguChek and TAS point-of-care whole blood prothrombin time monitors. / Poller, Leon; Keown, Michelle; Chauhan, Nikhil; Van den Besselaar, Anton M H P; Tripodi, Armando; Jespersen, Jorgen; Shiach, Caroline.

In: American Journal of Clinical Pathology, Vol. 119, No. 2, 01.02.2003, p. 232-240.

Research output: Contribution to journalArticle

Poller, Leon ; Keown, Michelle ; Chauhan, Nikhil ; Van den Besselaar, Anton M H P ; Tripodi, Armando ; Jespersen, Jorgen ; Shiach, Caroline. / European concerted action on anticoagulation : Minimum numbers of lyophilized plasma samples for ISI calibration of CoaguChek and TAS point-of-care whole blood prothrombin time monitors. In: American Journal of Clinical Pathology. 2003 ; Vol. 119, No. 2. pp. 232-240.
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