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目的验证乙型肝炎病毒表面抗原(HBsAg)酶联免疫吸附试验(ELISA)试剂盒的分析性能。方法参照美国临床实验室标准化研究所(CLSI)EP5-A2文件、第四版《全国临床检验操作规程》及相关文献对HBsAg的ELISA检测试剂盒的精密度、符合率、检出限、敏感性和特异性等进行验证。结果 HBsAg的ELISA试剂盒测量重复性CV为4.85%,中间精密度CV为13.35%;阴、阳性符合率为100%;试剂盒的敏感性和特异性均为100%,其阳性预测值100%,阴性预测值100%;试剂盒的C50-20%检测阳性结果2.5%(1/40)、C50+20%浓度的阳性结果95%(38/40),即-20%~+20%浓度范围包含了C5-C95区间,检出限为0.12IU/ml。结论 HBsAg的ELISA试剂盒检测结果可靠,能够满足临床需求。
Objective To verify the analytical performance of Hepatitis B virus surface antigen (HBsAg) enzyme-linked immunosorbent assay (ELISA) kit. Methods According to the CLSI EP5-A2 document, the fourth edition of the “National Clinical Laboratory Procedures” and related literature, the precision, the coincidence rate, the detection limit and the sensitivity of ELISA kit for HBsAg And specificity to verify. Results The CV of HBsAg ELISA kit was 4.85%, the intermediate precision CV was 13.35%, the positive and negative coincidence rate was 100%, the sensitivity and specificity of the kit were all 100%, and the positive predictive value was 100% , The negative predictive value was 100%; the positive result of C50-20% of the kit was 2.5% (1/40), the positive result of C50 + 20% was 95% (38/40), that is, the concentration of -20% ~ + 20% The range includes the C5-C95 interval with a limit of detection of 0.12 IU / ml. Conclusion HBsAg ELISA kit test results are reliable and can meet the clinical needs.