ELISA法检测血清IgM抗体诊断急性期手足口病患儿CV-A16感染效能的Meta分析  

Meta-analysis of the efficacy of ELISA to detect serum IgM antibodies in the diagnosis of CV-A16 infection in children with acute hand,foot and mouth disease

作　　者：张天琛[1] 章承锋[1] 潘欢弘[1] 赵玉芹[1] ZHANG Tian-chen;ZHANG Cheng-feng;PAN Huan-hong;ZHAO Yu-qin(Jiangxi Provincial Center for Disease Control and Prevention,Nanchang,Jiangxi 330029,China)

机构地区：[1]江西省疾病预防控制中心,江西南昌330029

出　　处：《现代预防医学》2022年第11期2048-2053,共6页Modern Preventive Medicine

基　　金：江西省卫生计生委科技计划(20186012,202130998);江西省科学基金(20171BAB215051)。

摘　　要：目的 定量评价酶联免疫吸附测定法(enzyme linked immunosorbent assay,ELISA)检测血清CV-A16免疫球蛋白M(IgM)抗体的诊断效能。方法 制定相应的研究目标和检索策略,系统地检索中、外文数据库,以HFMD患儿急性期呼吸道/或肠道标本CV-A16核酸检测为“参考标准”,采用Meta分析及Meta回归的方法,定量地评价ELISA法检测血清CV-A16 IgM抗体诊断HFMD患儿CV-A16感染的效能。结果 基于随机效应评估9篇原始研究,ELISA法诊断HFMD患儿CV-A16感染效能的合并灵敏度为65%(95%CI:47%~81%),合并特异度为92%(95%CI:88%~95%),合并阳性预测值为61%(95%CI:33%~85%),合并阴性预测值为93%(95%CI:90%~96%),合并曲线下面积为0.92±0.04;Meta回归发现研究样本量大小、CV-A16病例占比是导致不同研究结果灵敏度及阳性预测值异质性的主要因素。结论 目前的ELISA试剂盒检测血清CV-A16 IgM的诊断效能相对较差,临床应用需谨慎,仍需要进一步加强ELISA法试剂盒的研发。Objective To quantitatively evaluate the efficacy of enzyme linked immunosorbent assay(ELISA) kit detecting serum Immunoglobulin M(IgM) antibody in the diagnosis of CV-A16 infection among children with hand,foot and mouth disease(HFMD).Methods The corresponding research objectives and the search strategies were developed,and Chinese and English databases were systematically searched.Taking the CV-A16 nucleic acid detection of acute respiratory tract or intestinal specimens as the “reference standard”,Meta-analysis and Meta regression were used to quantitatively evaluate the efficacy of ELISA kit detecting serum IgM antibody in the diagnosis of CV-A16 infection among children with HFMD.Results Based on the random effects model of the evaluation in 9 original studies,the pooled sensitivity of the ELISA kit for the diagnosis of CV-A16 infection in children with HFMD was 65%(95%CI:47%-81%),the pooled specificity was 92%(95%CI:88%-95%),the pooled positive predictive value was 61%(95%CI:33%-85%),the pooled negative predictive value was 93%(95%CI:90%-96%),and the pooled Area Under Curve was 0.92±0.04.Meta regression found that the sample size and the proportion of CV-A16 cases were the main factor leading to the heterogeneity of the sensitivity and positive predictive value.Conclusion The current ELISA kits have relatively poor diagnostic efficiency for diagnosing CV-A16 infection,which are not suitable for clinical applications.Therefore,it is still necessary to further strengthen the research and development of ELISA kits.

关 键 词：手足口病 柯萨奇病毒A16 ELISA IgM META分析 

分 类 号：R117[医药卫生—公共卫生与预防医学] R725.1