治疗制品

酶联免疫吸附试验检测乙型肝炎核心抗体IgM中的cutoff值优化

  • 柴瑜 苏颖 王斌冰 罗献伟 程晓东 周淑洁 唐继海
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  • 安徽省疾病预防控制中心免疫预防科,合肥 230061

网络出版日期: 2025-08-16

基金资助

中国乙肝防控科研基金(YGFK20190031

Optimization of cutoff value inELISA for the detection ofhepatitis B core antibody IgM

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  • Immunization and Prevention Department, Anhui Provincial Center for Disease Control and Prevention, Hefei 230061, China

Online published: 2025-08-16

Supported by

Hepatitis B Prevention and Control Research Fund of China (YGFK20190031)

摘要

目的 优化ELISA检测乙型肝炎核心抗体IgM的cutoff值。方法 372份血清样本分别使用ELISA和化学发光免疫分析两种方法进行检测,检测结果使用受试者工作特征(receiver operating characteristic,ROC)曲线分析确定优化的cutoff值,再统计分析优化前后的检测结果。结果 化学发光免疫分析结果:阳性129份,阴性243cutoff值为0.105时ELISA检测结果:阳性230份,阴性142份Kappa检验显示两方法的结果一致性仅为中度(Kappa=0.49P<0.001)。ROC曲线进行分析,得到最佳的cutoff值0.296,此时特异度、正确指数和符合率均优于cutoff值设为0.105时各项指标,灵敏度稍有降低Kappa检验显示两方法的结果一致性升为高度(Kappa=0.85P<0.001)。结论 cutoff值设为0.296时,ELISA的检测结果和化学发光免疫分析结果一致性更好。


本文引用格式

柴瑜 苏颖 王斌冰 罗献伟 程晓东 周淑洁 唐继海 . 酶联免疫吸附试验检测乙型肝炎核心抗体IgM中的cutoff值优化[J]. 国际生物制品学杂志, 2022 , 45(3) : 140 -143 . DOI: 10.3760/cma.j.cn 311962-20211118-00074

Abstract

Objective  To optimize the cutoff value of ELISA for the detection of hepatitis B core antibody IgM. Methods  Three hundred and seventy-two specimens were tested by two methods, ELISA and chemiluminescence immunoassay (CLIA). The results were analyzed using Receiver Operating Characteristic (ROC) curve to determine the optimized cutoff values, and then statistical analysis was performed on the results before and after optimization. Results  CLIA results were 129 positive and 243 negative. ELISA results at cutoff value of 0.105 were 230 positive and 142 negative. Kappa test showed a moderate agreement between the results of the two methods (Kappa=0.49, P<0.001). The ROC curves were analyzed and the best cutoff value of 0.296 was obtained. Specificity, correctness index, and agreement rate were better than thosat cutoff value of 0.105, except for a slight decrease in sensitivity. Kappa test showed a high level agreement between the results of the two methods rose to (Kappa=0.85, P<0.001). Conclusion  The results of ELISA and CLIA are in better agreement with the cutoff value of ELISA set at 0.296.

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