Why the study?
Does the CoaguChek point-of-care testing prothrombin time monitor accurately measure INR compared to certified INR plasma samples?
Does the CoaguChek point-of-care testing prothrombin time monitor accurately measure INR compared to certified INR plasma samples?
While mean CoaguChek INR values align with certified standards, over 20% of monitors exhibit significant deviations (≥15%), highlighting the critical need for routine, large-scale quality assessment of point-of-care INR devices.
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May warrant enhanced QA for CoaguChek devices; leaves open effects on patient-level accuracy and dosing.
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.
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Meijer et al. (2006) studied this question.
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