Identification of anticoagulants in a sample

Abstract

The present invention is directed to a novel method of determining inhibitors of proteolytically active coagulation factors, referred to herein as anticoagulants, in a sample, in particular the qualitative detection of direct thrombin and factor Xa inhibitors in a sample. The method of the present invention allows a qualitative determination of the nature anticoagulants present in a sample. This can be achieved with only one coagulation-based test. The method can be used in a test kit, including a point-of-care system.

1 - 11 . (canceled) 
     
     
         12 . A method for identification of a drug inhibiting coagulation-factor IIa or factor Xa in a sample, preferably selected from blood or plasma, comprising the steps of:
 (a) establishing the reference ranges for prothrombinase-induced clotting time (PiCT®) using reference samples with increasing concentrations of known anti-coagulants,   (b) mixing the sample to be tested with PiCT®-activator and PiCT®-start reagent, in particular wherein the start reagent is added before addition of the activator reagent,   (c) measuring and comparing the PiCT®;   wherein the presence of an anti-coagulant in the test sample is indicated by a PiCT® out of range.   
     
     
         13 . A method according to  claim 12 , using only one coagulation-based test, in particular prothrombinase-induced clotting time (PiCT®) assay. 
     
     
         14 . A method according to  claim 12  comprising prothrombinase-induced clotting time (PiCT®) assay, wherein the start reagent is added to the sample before the mixing with activator reagent. 
     
     
         15 . A method according to  claim 12 , wherein the anti-coagulation drug is selected from direct oral anti-coagulants (NOACs), preferably rivaroxaban, apixaban and dabigatran. 
     
     
         16 . A method according to  claim 12 , wherein PiCT® assay combined with activated partial thrombin time (aPTT) and/or prothrom bin time (PT). 
     
     
         17 . The method according to  claim 12 , wherein the sample comprises an anticoagulant selected from the group consisting of UFH, LMWH, hirudin, fondaparinux, argatroban, dabigatran, rivaroxaban and apixaban. 
     
     
         18 . A method according to  claim 12  for quantification the effect of anticoagulants in a sample, preferably selected from humans or animals, more preferably selected from blood or plasma, using prothrombinase-induced clotting time (PiCT®) assay. 
     
     
         19 . Use of a combination of prothrombin time (PT), activated partial thromboplastin time (aPTT) and prothrombinase-induced clotting time (PiCT®) for identification of inhibitors of coagulation in a sample, preferably selected from blood or plasma. 
     
     
         20 . Use according to  claim 19 , wherein the inhibitors of coagulation are selected from direct thrombin and factor Xa inhibitors. 
     
     
         21 . Use according to  claim 19 , wherein within the prothrombinase-induced clotting test the activator can be added before or after the addition of the start reagent. 
     
     
         22 . Use of a method according to  claim 12  in a point-of-care system.