Quality assurance program for whole blood prothrombin time-international normalized ratio point-of-care monitors used for patient self-testing to control oral anticoagulation

Armando Tripodi, Caterina Bressi, Monica Carpenedo, Veena Chantarangkul, Marigrazia Clerici, Pier Mannuccio Mannucci

Research output: Contribution to journalArticle

Abstract

Whole blood coagulation monitors are increasingly used for patient self-testing to control oral anticoagulation, but there are no comprehensive quality assurance (QA) programs to check their performance. We report on the experience with one of such programs applied in a field study where patients on prothrombin time (PT)-international normalized ratio (INR) self-testing were asked to bring their monitors to the anticoagulation clinic for checking. PT-INR testing was performed three times over 3 months with 14 patient's monitors and test strips on three recalcified QA plasmas by an experienced laboratory operator. Each patient was also asked to perform PT-INR self-testing (his/her own capillary blood) which was then compared to the laboratory PT-INR (plasma). Overall, the comparison between the observed and the consensus PT-INR on QA plasmas was acceptable with the majority of measurements lying within ±15% or 20% of the consensus values. The comparison between the PT-INR self-testing and the laboratory method was also acceptable: overall, there was no statistical significant difference between the mean PT-INR values and the majority of paired measurements were less than 15% or 20% apart. In conclusion, our results show that the proposed QA scheme is feasible and may be implemented on a larger scale. Monitors should be recalled periodically to the clinic where they have been prescribed to the patient. During each visit, the clinic may check the monitors and patient self-testing performance as described. Such comprehensive QA system would make monitoring of oral anticoagulant treatment by self-testing safer and more effective.

Original languageEnglish
Pages (from-to)35-40
Number of pages6
JournalThrombosis Research
Volume113
Issue number1
DOIs
Publication statusPublished - 2004

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Keywords

  • INR
  • Monitor
  • Oral anticoagulant treatment
  • Point of care
  • Self-testing

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Hematology

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