Harmonization of the results of automated coagulation tests with different analyzers

Abstract

Objective To investigate the harmonization of results of Prothrombin time(PT),International Normalized Ratio(INR),activated partial thromboplastin time(APTT),fibrinogen(FIB)and thrombin time(TT)with different coagulation analyzers in different or sanle clinical laboratory.Methods PT,INR,Am,FIB and TT for the same quality control material were detected with 14 different coagulation analyzers,which are distributed in 12 clinical laboratories and classified into A,B and C group.MeaJlwhile,PT,INR,APTT,FIB of 139 samples were detected with two different coagulation aJlalyzers in the same laboratory.Results There was no significant difference for detection of level 3 of both INR and TT among the three group analyzers(P＞0.05),but there was significant difference for other tests (P＜0.05).The comparison between groups showed that there was high percentage(66.7%)of consistency for detection of INR,FIB-C and TT between group B and C.The results of two different coagulation analvzers ( ACL Futura and CA 510)in same laboratory showed that there was no significant difference(P＞0.05)for detection of PT,INR,PT-FIB and FIB-C between them,and there was good eorrelation for them in detecting PT,INR,APTT,PT-FIB and FIB-C(r＞0.975).Analysis of bias showed that the bias of PT,INR,PT-FIB and FIBC between the two different coagulation analyzers was acceptable according to CLIA'88.Conclusion There are good agreement for the results between different coagulation analyzers based upon the similar Drinciple in coagulation analysis. Key words: Blood coagulation tests; Diagnostic equipment; Evaluation studies