Abstract: Objective　To quantitatively evaluate the diagnostic value of variable?temperature and isothermal nucleic acid amplification techniques in the detection of schistosomiasis japonica using a meta?analysis. Methods　The publications pertaining to the nucleic acid detection of schistosomiasis japonica were searched in electronic databases, including Chinese National Knowledge Infrastructure (CNKI), Wanfang Data, PubMed and ScienceDirect, and the compilations and proceedings of schistosomiasis were manually searched. In addition, the citations of publications associated with the nucleic acid detection of schistosomiasis japonica were traced using a document tracing method. The retrieved literatures were screened according to the inclusion and exclusion criteria, and data were extracted from the included literatures. The quality of the included literatures was assessed using the software RevMan version 5.3, and a meta?analysis was performed using the software MetaDiSc version 1.4. Results　A total of 19 publications covering 24 groups of studies were enrolled, including 5 Chinese publications and 14 English publications. There were 17 groups of studies reporting the comparison between the variable?temperature nucleic acid amplification technique and the golden standard, and 7 groups of studies showing the comparison between the isothermal nucleic acid amplification technique and the golden standard. Assessment of the literature quality indicated a minor overall bias of the included literatures, and the Deek funnel plot showed a possible publication bias in the documents reports variable?temperature nucleic acid amplification techniques. There was a heterogeneity caused by non?threshold effect among the studies associated with the variable?temperature amplification technique, and the random effects model was therefore used to combine the effects. The pooled sensitivity and specificity of the variable?temperature amplification technique were 0.81 (0.79 to 0.83) and 0.73 (0.71 to 0.74) for the diagnosis of schistosomiasis japonica, and area under the SROC curve was 0.944 3. There was no heterogeneity among the studies associated with the isothermal amplification technique, and the fixed effects model was therefore used to combine the effects. The pooled sensitivity and specificity of the isothermal amplification technique were 0.96 (0.94 to 0.98) and 0.95 (0.94 to 0.97) for the diagnosis of schistosomiasis japonica, and area under the SROC curve was 0.989 9. Conclusion　Both variable?temperature and isothermal nucleic acid amplification techniques have a high efficiency for the diagnosis of schistosomiasis japonica, and the isothermal amplification technique shows a relatively higher accuracy than the variable?temperature amplification technique. 　

Key words: Schistosomiasis japonica, Diagnostic test, Nucleic acid detection, Meta?analysis

摘要： 目的　应用诊断试验meta分析，定量评价核酸检测中变温和等温扩增技术对日本血吸虫病的诊断价值。方法　通过计算机检索1990年1月-2019年6月中国知网、万方数据知识服务平台、PubMed数据库和ScienceDirect数据库中公开发表的日本血吸虫病核酸检测相关文献，手工查阅《血吸虫病研究资料汇编》及论文集等纸质出版物，并以文献追溯法对相关文献引文进行追溯查找。按照纳入与排除标准对检索的文献进行筛选，提取纳入文献相关数据，采用RevMan 5.3软件对入选文献进行质量评价，采用MetaDiSc 1.4软件对数据进行meta分析。结果　最终纳入19篇文献，其中中文文献5篇、英文文献14篇；共24组研究，其中17组研究涉及变温扩增技术与金标准的比较、7组研究涉及等温扩增技术与金标准的比较。文献质量评价结果表明，所纳入文献总体偏倚较小；Deek漏斗图提示变温扩增技术相关文献可能存在发表偏倚。变温扩增技术相关研究间存在非阈值效应引起的异质性，故采用随机效应模型合并效应量；合并分析结果示，其检测日本血吸虫病的综合灵敏度为0.81（0.79，0.83）、特异度为0.73（0.71，0.74）、SROC曲线下面积为0.944 3。等温扩增技术相关研究间不存在异质性，故使用固定效应模型进行效应量合并；合并分析结果显示，其检测日本血吸虫病的综合灵敏度为0.96（0.94，0.98）、特异度为0.95（0.94，0.97）、SROC曲线下面积为0.989 9。结论　变温扩增技术和等温扩增技术对日本血吸虫病均有较高诊断价值，等温扩增技术诊断准确性相对更高。

关键词: 日本血吸虫病, 诊断试验, 核酸检测, meta分析