MULTICENTER EVALUATION OF A NEW CAPILLARY BLOOD PROTHROMBIN TIME MONITORING-SYSTEM

The analytical performance of the new capillary blood prothrombin time monitoring system CoaguChek(TM) was examined in a multicenter evaluat ion at six hospitals. The coefficients of variation of the INR obtaine d in the CoaguChek(TM) imprecision study were approximately 7% in the control plasma provided (within-run and day-to-day) and 4% in blood (w ithin-run). The prothrombin times were ascertained in capillary blood (CoaguChek(TM) PT Test) and citrated venous plasma (Hepato Quick, Thro mborel(TM) S) from 359 patients under oral anticoagulation therapy wit h phenprocoumon, acenocoumarin or warfarin. The agreement with the tes t results obtained with the comparison methods was acceptable versus H epato Quick assay (n = 359; y = 1.23 x - 0.49, r = 0.888) and good ver sus Thromborel(TM)S method (n = 359; y = 1.09 x - 0.28, r = 0.895). A simplified assessment of all test results (n = 795) in a nine-field co mparison table showed a concordance with the comparison methods of mor e than 80 (Hepato Quick: 81%, Thromborel(TM) S: 83%), The concordance between Hepato-Quick and Thromborel(TM) S was slightly higher (88%). I ts good analytical performance and convenient handling recommend the C oaguChek(TM) system as a suitable system for decentralized prothrombin time testing.