ELISA检测血清EV71-IgM诊断手足口病价值的Meta分析

Value of EV71-IgM tested by enzyme-linked immunosorbent assay in diagnosis of hand,foot and mouth disease:a meta-analysis

目的系统评价酶联免疫吸附试验(ELISA)检测血清肠道病毒71型IgM抗体(EV71-IgM)诊断手足口病(HFMD)的价值。方法检索PubMed、Embase、Web of Science、Cochrane、维普、万方、中国知网以及中国医学生物文献数据库中有关用ELISA检测EV71-IgM诊断HFMD的文献,检索时限从建库至2015年1月。对符合纳入标准的文献进行资料提取、方法学质量评价,采用Meta-disc 1.4软件进行Meta分析。结果共纳入文献8篇,合计4 126例,其中HFMD患者1 484例,非HFMD患者2 642例。Meta分析结果显示,各研究间存在非阈值效应引起的异质性,合并灵敏度、特异度和诊断比值比分别为84%、90%、28.77;拟合综合受试者特征曲线(SROC)下面积为0.906 8。结论 ELISA检测血清EV71-IgM诊断HFMD有较高的诊断价值,但因纳入研究存在一些方法学缺陷,该结论尚需进一步开展高质量的诊断性试验来进行验证。

Objective To systematically review the diagnostic value of EV71-IgM tested by enzyme-linked immunosorbent assay（ELISA）in patients with Hand,Foot and Mouth Disease（HFMD）.Methods Such databases as PubMed,Embase,Web of Science,Cochrane,VIP,Wan Fang Data,CNKI,and CBM were searched for studies about the diagnostic value of EV71-IgM tested by ELISA in patients with HFMD from inception to January,2015.We screened literature according to inclusion criteria,extracted data,and assessed methodological quality of included studies.Meta-analysis was conducted using Meta-Disc 1.4software.Results A total of eight studies were included,involving a total of 4 126 clinical samples,1 484 of which with EV71 and 2 642 of which with non-EV71.The results of meta-analysis showed that heterogeneity was found in these studies,excepting for threshold effect and the pooled sensitivity,specificity,diagnostic odds ratio（DOR）and the area under the SROC curve was 84%,90%,28.77 and 0.906 8,respectively.Conclusion EV71-IgM tested by ELISA has certain value in the diagnosis of patients with HFMD.But due to some poor methodological qualities of the included studies,the above conclusion should be verified by conducting high quality diagnostic tests.