目的：验证和评价全自动酶联免疫分析仪测定甲型肝炎病毒（hepatitis A virus,HAV）IgM的性能。方法：本实验参照美国临床和实验室标准化协会（Clinical and Laboratory Standards Institute, CLSI）的 EP15-A2 文件和中国合格评定国家认可委员会（China National Accreditation Service for Conformity Assessment,CNAS）的CNAL-CL39相关文献,对全自动酶联免疫分析仪测定HAV-IgM的精密度、检出限、正确度以及试剂盒的临界值进行验证。结果：全自动酶联免疫分析仪检测HAV-IgM的批内精密度变异系数（coefficient of variation,CV）为7.77%,批间精密度CV为11.17%,阳性及阴性结果符合率均为100%,检出限为1.0 NCU/mL,符合实验室的要求,与厂家的声明（2.0 NCU/mL）相接近。在临界值验证实验中,检测的样本吸光度值的均值（$\bar{x}$）+3个标准差（SD）=0.032,小于试剂盒提供的临界值（0.105）。结论：全自动酶联免疫分析仪检测HAV-IgM的精密度、正确度、检出限、诊断临界值结果均符合行业标准要求,可满足临床的需要。

Objective: To verify and evaluate the performance of a full automatic enzyme immunoassay analyzer (Tecan) for the detecting of hepatitis A virus(HAV)-IgM. Methods: According to the EP5-A2 document of Clinical and Laboratory Standards Institute（CLSI）and related documents of China National Accreditation Service for Conformity Assessment-CL39（CNAL-CL39） in combination with the condition of our laboratory, the precision, detection limit, accuracy and cut off value of the full automatic enzyme immunoassay analyzer Tecan for the detecting of HAV-IgM were eva-luated.Results: The intra-and inter-batch coefficient of variation (CV) of Tecan for detecting HAV-IgM were 7.77% and 11.17%, respectively, and the coincidence rates of both positive and negative results were 100%. The detection limit was 1.0 NCU/mL, which met the requirement of laboratory and was close to the statement of manufacturer (2.0 NCU/mL). In the validation experiment for cut-off value, the light absorption value ($\bar{x}$+3SD)=0.032 was less than the value 0.105 provided by the kit. Conclusions: The precision, accuracy, detection limit and cutoff value of the automatic enzyme immunoassay analyzer Tecan for detecting HAV-IgM meet the requirements of manufacturer's standards and clinical needs.