Evaluation of ACL TOP coagulation analytical system in the laboratory of children′s hospital

Objective To evaluate the performance of ACL TOP coagulation analyzer system in the laboratory of children′ s hospital. Methods According to the documents of CLSI, the analytic characteristics including precision, accuracy, linearity, interference and carryover rate were examined; specimens from healthy children were collected and assayed to determine the reference range of Prothrombin Time(PT), Activated Partial Thromboplastin Time(APTT), Thrombin Time(TT), Fibrinogen(FIB) and D-Dimer(D-D) from children on ACL TOP. Results The within-run and between-day coefficient of variability(CV) were within an acceptable range; The accuracy deviation of PT, APTT and FIB were less than 1/2 allowed total errors; The results of determination of FIB linearity test were correlated with the results of calculation: Y=1.0021X-0.122, R2=0.9982; The extent of influence of low to middle grade of jaundice, fat and hemolysis on each test were all less than 1/2 allowed total error; The carryover rates were lower than 1.81% and within an acceptable range; The reference range of PT, APTT, TT and FIB were PT(9.1-13.1s), APTT(24.9-42.1s), TT(12.6-21.1s), FIB(1.924-4.011g/L). Conclusion The ACL TOP coagulation analyzer has good repeatability, stability, linearity and capability of anti-interference and anti-carryover.