Abstract: Objective To evaluate the performance of SYSMEX CS5100 automatic coagulation analyzer(CS5100), verify the reference ranges of coagulation indicators recommended by manufacturers, and establish our own laboratory reference ranges. Methods The prothrombin time(PT), activated partial thromboplastin time(APTT), thrombin time(TT), fibrinogen(FIB), D-dimer (DD) and fibrinogen degradation product(FDP) were determined in mixed plasma, quality control plasma and plasma from 222 healthy subjects by CS5100. Results According to the technical program by the International Council for Standardization in Haematology (ICSH), the analyzer had high precision, accuracy, good linear range and low carryover rate. The recommended reference ranges of TT, DD and FDP were appropriate for our laboratory. The reference ranges of PT, APTT and FIB (10.4-13.0 s, 19.5-30.3 s and 1.6-3.6 g/L) were established statistically. There was no statistical significance between male and female groups on the coagulation indicators(P>0.05). Conclusions In the basis of ensuring a good condition of CS5100, the reference ranges of coagulation indicators for our own laboratory are established and verified, which may provide accurate results for clinic.

Key words: Performance evaluation, SYSMEX CS5100 automatic coagulation analyzer, Reference range