全自动酶联免疫分析仪检测甲型肝炎病毒IgM抗体的性能验证
Performance verification of a full automatic enzyme immunoassay analyzer for the detecting of HAV-IgM antibody
Received date: 2019-11-20
Online published: 2020-02-25
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(
王峰蕾, 吴晓燕, 王志成 . 全自动酶联免疫分析仪检测甲型肝炎病毒IgM抗体的性能验证[J]. 诊断学理论与实践, 2020 , 19(1) : 84 -87 . DOI: 10.16150/j.1671-2870.2020.01.017
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 (
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