Point-of-care prothrombin time measurement for professional and patient self-testing use - A multicenter clinical experience

Sire enrolled 386 subjects in a multicenter study of a point-of-care (POC)p rothrombin time (PT) testing device. POC tests were performed by health car e professionals using venous and finger-stick specimens and by patients usi ng finger-stick specimens; Venous blood also was analyzed in the local hosp ital laboratory and a national reference laboratory. Accurate POC results w ere obtained by professionals using both types of specimens. Patients' resu lts were equivalent to those of professionals. The identification of the pa tient's therapeutic status based on the International Normalized Ratio (INR ) was equivalent for POC and local hospital laboratory PT results; 75% of l ocal laboratory results and 77% of POC results were within 0.4 INR of refer ence laboratory results, white 93% of either system (POC or local laborator y) were within 0.7 INR. Patients overwhelmingly reported satisfaction with the self-test, including the finger stick and device operation. The INR fro m the POC device is clinically equivalent to the laboratory INR for assessm ent of anticoagulation status and management decisions in professional and self-testing environments. Patients can learn to perform accurate PT testin g and POC PT testing is feasible in patients' homes.