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Point-of-care monitoring of vitamin K-antagonists: validation of CoaguChek XS test strips with International Standard thromboplastin
  1. Anton M H P van den Besselaar1,
  2. Nathalie C V Péquériaux2,3,
  3. Marij Ebben2,
  4. Joke van der Feest4,
  5. Kerst de Jong5,
  6. Maria B J Ganzeboom6,
  7. Jetty van Ooijen7,
  8. Ferna Postema8,
  9. Evelina Witteveen1,
  10. Felix J M van der Meer1,5
  1. 1Department of Thrombosis and Hemostasis, Leiden University Medical Centre, Leiden, The Netherlands
  2. 2Thrombosis Service, Jeroen Bosch Ziekenhuis, 's-Hertogenbosch, The Netherlands
  3. 3Department of Clinical Chemistry and Haematology, Jeroen Bosch Hospital, s-Hertogenbosch, The Netherlands
  4. 4Thrombosis Service, Saltro, Utrecht, The Netherlands
  5. 5Thrombosis Service, Leiden, The Netherlands
  6. 6East Netherlands Anticoagulation Center ASCON, Enschede, The Netherlands
  7. 7INR Trombosedienst, Nijmegen, The Netherlands
  8. 8Thrombosis Service, Leeuwarden, The Netherlands
  1. Correspondence to Dr Anton M H P van den Besselaar, Department of Thrombosis and Hemostasis, Leiden University Medical Centre, PO Box 9600, Leiden 2300 RC, The Netherlands; a.m.h.p.van_den_besselaar{at}lumc.nl

Abstract

Aims Many patients treated with vitamin K-antagonists (VKA) use point-of-care (POC) whole blood coagulometers for self-testing. The majority of patients in the Netherlands use one type of POC coagulometer, that is, the CoaguChek XS. Each new lot of test strips for the CoaguChek XS is validated by a group of collaborating thrombosis centres. We assessed the International Normalised Ratio (INR) differences between each of 51 new lots of test strips and the International Standard for thromboplastin rTF/95 or its successor rTF/09.

Methods Each year, a particular lot of CoaguChek XS test strips was used as reference lot. The reference lot was validated by comparison to the International Standard, yielding a relationship between the reference lot INR and International Standard INR. Successive lots of test strips were compared to the reference lot by three centres using 19–29 capillary blood samples obtained from VKA-treated patients. Each patient provided two blood drops from the same finger prick, one for the reference lot strip and one for the new lot.

Results The mean INR differences between each lot and the International Standard varied between −8% and +4%. The mean absolute values of the relative differences varied between 2.4% and 8.1%. There were small but clinically unimportant differences in INR between the first and second drop of blood.

Conclusions Accuracy of CoaguChek XS INR determinations can be assessed by a group of collaborating centres using a limited number of capillary blood samples. As the mean INR differences with the International Standard were smaller than 10%, the lots were approved for use by the Netherlands Thrombosis Services.

  • Anticoagulants
  • Poc Testing
  • Laboratory Tests

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Footnotes

  • Funding Roche Diagnostics Nederland BV.

  • Competing interests The institution of author AvdB received payment from Roche Diagnostics Nederland BV for stability monitoring of CoaguChek XS test strips.

  • Ethics approval Leiden University Medical Center Ethics Committee.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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