Performance Verification of ACL-TOP Automatic Coagulation Analyzer Detection System

Objective To verify the main performances of ACL-TOP automatic coagulation analyzer from Beckman-Coulter of America.Methods Prothrombin time(PT),active partial thromboplastin time(APTT),fibrinogen(FIB),thrombin time(TT) and D-Dimer(D-D) were selected to verify the performance of the equipment.The precision was evaluated by coefficient variation(CV),carry-over by carry-over rate,linear range by regression equation and the comparison of different machines by relative deviation.Results The precision of PT,APTT,FIB,TT and D-D were lower than 6%.All the precision of selected testing items were within an acceptable range.The carryover rates of PT,APTT,FIB,TT and D-D were 0.43%,1.56%,1.06%,1.43% and 1.98%,respectively.The linear verification results got the regression equation of the theoretical and measured values y=bx+a,in which b was within the range of 0.97～1.03,and r0.975.The relative deviation in different machines was lower than 1/2 total errors(TE) provided by equipment factory.Conclusion The precision,carryover rates,the comparison results in different machines and linearity of the selected testing items of ACL-TOP automatic coagulation analyzer accord with the demands of the experiments in clinical diagnosis,which can be used clinically.