A national field study of quality assessment of CoaguChek point-of-care testing prothrombin time monitors

Piet Meijer, Cornelis Kluft, Leon Poller, Felix J M Van Der Meer, Michelle Keown, Saied Ibrahim, Anton M H P Van Den Besselaar, Armando Tripodi, Jørgen Jespersen

Research output: Contribution to journalArticlepeer-review

Abstract

A system for quality assessment (QA) of the CoaguChek (Roche Diagnostics, Mannheim, Germany) point-of-care testing prothrombin time monitor has been developed by the European Concerted Action on Anticoagulation. Hitherto there has not been an adequate rapid method for CoaguChek QA. Sets of 5 certified international normalized ratio (INR) plasma samples were tested on 539 CoaguChek monitors by experienced staff at 9 Netherlands Thrombosis Centers and results compared with certified INR. A 15% or more deviation has been classified as significant deviation. Overall mean and certified INR values were similar, but 20.3% of participants showed a 15% or more deviation from the certified INR on at least 1 of the 5 QA plasma samples. Statistically significant differences in results with different lots of CoaguChek test strips were found. There is need for large scale QA of CoaguChek monitors. The importance of the 5 CoaguChek certified INR QA plasma samples being tested on a single occasion is demonstrated.

Original languageEnglish
Pages (from-to)756-761
Number of pages6
JournalAmerican Journal of Clinical Pathology
Volume126
Issue number5
DOIs
Publication statusPublished - Nov 2006

Keywords

  • CoaguChek monitors
  • Prothrombin time
  • Quality assessment
  • Significant deviation

ASJC Scopus subject areas

  • Pathology and Forensic Medicine

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