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  

Optimization of cutoff value in ELISA for the detection of hepatitis B core antibody IgM

作　　者：柴瑜[1] 苏颖[1] 王斌冰[1] 罗献伟[1] 程晓东 周淑洁[1] 唐继海[1] Chai Yu;Su Ying;Wang Binbing;Luo Xianwei;Cheng Xiaodong;Zhou Shujie;Tang Jihai(Immunization and Prevention Department,Anhui Provincial Center for Disease Control and Prevention,Hefei 230061,China)

机构地区：[1]安徽省疾病预防控制中心免疫预防科,合肥230061

出　　处：《国际生物制品学杂志》2022年第3期140-143,共4页International Journal of Biologicals

基　　金：中国乙肝防控科研基金(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243份;cutoff值为0.105时ELISA检测结果:阳性230份,阴性142份。K_(appa)检验显示两方法的结果一致性仅为中度(K_(appa)=0.49,P<0.001)。对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,K_(appa)检验显示两方法的结果一致性升为高度(K_(appa)=0.85,P<0.001)。结论将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。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.K_(appa)test showed a moderate agreement between the results of two methods(K_(appa)=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 those at cutoff value of 0.105,except for a slight decrease in sensitivity.K_(appa)test showed a high level agreement between the results of the two methods(K_(appa)=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.

关 键 词：抗乙型肝炎病毒核心抗体IgM 酶联免疫吸附检测 化学发光免疫分析 受试者工作特征曲线 Cutoff值优化 

分 类 号：R373[医药卫生—病原生物学]