Validation of a whole blood coagulometer sensitive to the direct oral anticoagulants

Abstract

Abstract Readily available and rapid turn-around, bedside assays to measure the effect of the direct oral anticoagulants (DOACs) are not available. This study evaluates a point-of-care (PoC) coagulometer to assess the anticoagulant effects of the DOACs and low molecular weight heparin. Studies were done in fresh spiked blood from healthy volunteers. PoC coagulometer baseline clotting times were half that of the manual whole blood clotting time (WBCT, legacy method) and exhibited a sensitivity to DOAC anticoagulation approximately twice that of WBCT. All %CV values for both methods were 0.98 indicating a strong correlation between the two methods. Replicate measurements for all subjects showed a maximum upper %CV value of 5.56% and a maximum upper value of all absolute %Differences of 5.5%, with both criteria meeting predefined acceptance criteria. The dose–response curves for all subjects were linear across the concentration ranges tested. The Perosphere Technology PoC coagulometer detects a range of therapeutic levels of the DOACs apixaban, rivaroxaban, edoxaban, and dabigatran, as well as the low molecular weight heparin, enoxaparin, with high precision and sensitivity.

Keywords

• Anticoagulation
• Point-of-care
• Coagulometer
• Direct oral anticoagulants
• Coagulation assay