Abstract：Objective To compare and analyze the performance of three automatic luminescence immunoassays for Sysmex
HISCOL5000, Soling LIAISON-XL and Roche-combas-E602 to detect antibodies against hepatitis C virus. Methods According
to the EP5-A2 and EP12-A2 documents recommended by the American Association for Clinical and Laboratory Standardization
(CLSI) and “People’s Republic of China Health Industry Standards-Qualitative Measurement Performance Evaluation Guidelines
(WS/T505-2017)”, The precision, accuracy, detection limit, clinical sensitivity, specificity of anti-HCV assay were evaluated, and the
results were consistent with those of recombinant recombinant immunoblotting experiment (RIBA). Results The precision variation
coefficient of anti-HCV detected by the three instruments was relatively small丨 the conformity rate of the re-test of the retained
samples of inter-room quality evaluation (EQA) was 100%丨 The detection limit concentrations of Sysmex HISCOL5000, LIAISONXL,
Roche-E602 were 0.4 NCU/mL, 0.7 NCU/mL, 0.04 NCU/mL丨 the clinical specificity of the three instruments were 97.96%,
96.94% and 98.64%, and the Clinical sensitivity was 100% (95% confidence interval: 95.95-100)丨 The detection results of Sysmex
HISCOL5000 and Roche-E602 were highly consistent with RIBA, and the agreement rate between the LIAISON-XL and RIBA
confirmation experiments was the lowest丨 In the distribution of LIAISON-XL results, gray areas and weakly reactive specimens
accounted for the largest proportion. Conclusion The instruments of different manufacturers have different performances in detecting
hepatitis C virus antibodies. It is necessary to purchase instruments on the basis of fully understanding the performance and formulate
scientific testing procedures to further improve the diagnostic efficiency of hepatitis C.
刘兆宇a，肖征a，张自豪a，程菲a，周月a，张晓b. 三种全自动发光免疫分析仪检测丙型肝炎病毒抗体性能比较[J]. 中国医疗设备, 2021, 36(5): 37-41.
LIU Zhaoyua，XIAO Zhenga，ZHANG Zihaoa，CHENG Feia，ZHOU Yuea，ZHANG Xiaob. Comparison of the Performance of Three Automatic Luminescence Immunoassay Analyzers
for Detecting of Hepatitis C Virus Antibody. China Medical Devices, 2021, 36(5): 37-41.
