Evaluation of Performance of STAGO 4-channel Coagulation Analyser and Quality Assurance

Objective To assess the performance of STAGO 4-channel semi-auto coagulation analyser and assure the quality of examined items. Methods The accuracies of items including prothrombin time(PT), activated partial thromboplastin time (APTT)and fibrinogen(FIB)were measured;PT and FIB were linearly analysed;New and used cups,Controls and self-made controls were compared, respectively.Results Items of PT and FIB were found to show good linearity( r = 0.9999, r =-0.9880);Coefficents of variation (CV) of the accuracies of the items including PT、APTT and FIB were all lower than 1.13%,CV of coagulation control of between-days 1.22%;CV of between-days(1～30d)is lower than 1.26%;Level 1:no significantly diffrence was noted between 1～30d and 30～60d ( P 0.05);Self-made Controls :significantly diffrence is noted between 1～30d and 30～60d (p0.001);No significantly diffrence was noted between new and used cups ( P 0.05).Conclusions The working principle of STAGO 4-channel semi-auto coagulation analyser is advanced ball-clotting measurement, its accuracy and senstivity can be improved by the automatic mode. Operation regulations should be conducted strictly to assure the quality in testing and the reliability of the results used in clinic.