Evaluating the performance of common reference laboratory tests for acute dengue diagnosis: a systematic review and meta-analysis of RT-PCR, NS1 ELISA, and IgM ELISA

IF 20.4 1区 生物学 Q1 INFECTIOUS DISEASES
Kamla Pillay MSc , Suzanne H Keddie PhD , Elizabeth Fitchett MPH , Cassandra Akinde MSc , Oliver Bärenbold PhD , Prof John Bradley PhD , Jane Falconer MA , Prof Ruth H Keogh PhD , Zhia Ning Lim MRes , Behrouz Nezafat Maldonado MSc , Laura Maynard-Smith MBBS , Ellen Sugrue MSc , Okuda Taylor MSc , Heidi Hopkins MD , Audrey Dubot-Pérès PhD
{"title":"Evaluating the performance of common reference laboratory tests for acute dengue diagnosis: a systematic review and meta-analysis of RT-PCR, NS1 ELISA, and IgM ELISA","authors":"Kamla Pillay MSc ,&nbsp;Suzanne H Keddie PhD ,&nbsp;Elizabeth Fitchett MPH ,&nbsp;Cassandra Akinde MSc ,&nbsp;Oliver Bärenbold PhD ,&nbsp;Prof John Bradley PhD ,&nbsp;Jane Falconer MA ,&nbsp;Prof Ruth H Keogh PhD ,&nbsp;Zhia Ning Lim MRes ,&nbsp;Behrouz Nezafat Maldonado MSc ,&nbsp;Laura Maynard-Smith MBBS ,&nbsp;Ellen Sugrue MSc ,&nbsp;Okuda Taylor MSc ,&nbsp;Heidi Hopkins MD ,&nbsp;Audrey Dubot-Pérès PhD","doi":"10.1016/j.lanmic.2025.101088","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>Dengue fever is listed among the top ten global health threats by WHO. Prompt identification of dengue virus can guide clinical management and outbreak response, yet laboratory diagnosis is complex, costly, and lacks consensus on performance evaluation. This systematic review aims to provide reliable diagnostic accuracy estimates in order to inform global guidance and evaluate novel rapid diagnostic tests.</div></div><div><h3>Methods</h3><div>In this systematic review and meta-analysis, we searched nine literature databases on Feb 16, 2021, for reports on five common reference tests for dengue infection: NS1 ELISA, IgM ELISA, IgG ELISA, RT-PCR, and viral neutralisation test. Articles were included if they reported primary data from more than five participants to complete 2×2 tables comparing one of these tests (on human serum) with any comparator. Diagnostic accuracy was estimated using Bayesian random-effect meta-analysis, which does not require a gold-standard comparator. Risk of bias was assessed using QUADAS-2. This review is registered with PROSPERO (CRD42022341552).</div></div><div><h3>Findings</h3><div>Data were extracted from 161 articles, allowing analysis of multiple timeframes for three tests of interest. Pooled sensitivities of RT-PCR (0–4 days after symptom onset), NS1 ELISA (0–4 days), and IgM ELISA (1–7 days) were 95% (95% credible interval 77–99), 90% (68–98), and 71% (57–84), respectively. The corresponding pooled estimates of specificity were 89% (60–98), 93% (71–99), and 91% (82–95). A subanalysis of only studies at low risk of bias demonstrated similar estimates.</div></div><div><h3>Interpretation</h3><div>IgM ELISA shows poor diagnostic accuracy early in the symptom course. NS1 ELISA shows similar diagnostic accuracy to RT-PCR, which has important implications for global public health policy, given its relatively low cost and accessibility.</div></div><div><h3>Funding</h3><div>None.</div></div>","PeriodicalId":46633,"journal":{"name":"Lancet Microbe","volume":"6 7","pages":"Article 101088"},"PeriodicalIF":20.4000,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Lancet Microbe","FirstCategoryId":"99","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2666524725000163","RegionNum":1,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"INFECTIOUS DISEASES","Score":null,"Total":0}
引用次数: 0

Abstract

Background

Dengue fever is listed among the top ten global health threats by WHO. Prompt identification of dengue virus can guide clinical management and outbreak response, yet laboratory diagnosis is complex, costly, and lacks consensus on performance evaluation. This systematic review aims to provide reliable diagnostic accuracy estimates in order to inform global guidance and evaluate novel rapid diagnostic tests.

Methods

In this systematic review and meta-analysis, we searched nine literature databases on Feb 16, 2021, for reports on five common reference tests for dengue infection: NS1 ELISA, IgM ELISA, IgG ELISA, RT-PCR, and viral neutralisation test. Articles were included if they reported primary data from more than five participants to complete 2×2 tables comparing one of these tests (on human serum) with any comparator. Diagnostic accuracy was estimated using Bayesian random-effect meta-analysis, which does not require a gold-standard comparator. Risk of bias was assessed using QUADAS-2. This review is registered with PROSPERO (CRD42022341552).

Findings

Data were extracted from 161 articles, allowing analysis of multiple timeframes for three tests of interest. Pooled sensitivities of RT-PCR (0–4 days after symptom onset), NS1 ELISA (0–4 days), and IgM ELISA (1–7 days) were 95% (95% credible interval 77–99), 90% (68–98), and 71% (57–84), respectively. The corresponding pooled estimates of specificity were 89% (60–98), 93% (71–99), and 91% (82–95). A subanalysis of only studies at low risk of bias demonstrated similar estimates.

Interpretation

IgM ELISA shows poor diagnostic accuracy early in the symptom course. NS1 ELISA shows similar diagnostic accuracy to RT-PCR, which has important implications for global public health policy, given its relatively low cost and accessibility.

Funding

None.
评估急性登革热诊断常用参考实验室检测的性能:RT-PCR、NS1 ELISA和IgM ELISA的系统回顾和荟萃分析
背景:登革热被世卫组织列为全球十大健康威胁之一。及时识别登革热病毒可以指导临床管理和疫情应对,但实验室诊断复杂、昂贵,而且在绩效评估方面缺乏共识。本系统综述旨在提供可靠的诊断准确性估计,以便为全球指导和评估新的快速诊断测试提供信息。方法:在本系统综述和荟萃分析中,我们于2021年2月16日检索了9个文献数据库,获取了5种登革热感染常用参考检测方法的报道:NS1 ELISA、IgM ELISA、IgG ELISA、RT-PCR和病毒中和试验。如果文章报告了5名以上参与者的原始数据,则将其纳入2×2表格,将其中一项测试(关于人血清)与任何比较物进行比较。使用贝叶斯随机效应荟萃分析估计诊断准确性,不需要金标准比较器。使用QUADAS-2评估偏倚风险。本综述已在普洛斯彼罗注册(CRD42022341552)。结果:从161篇文章中提取数据,允许对三个感兴趣的测试的多个时间框架进行分析。RT-PCR(症状出现后0 ~ 4天)、NS1 ELISA(0 ~ 4天)和IgM ELISA(1 ~ 7天)的合并敏感性分别为95%(95%可信区间77 ~ 99)、90%(68 ~ 98)和71%(57 ~ 84)。相应的合并估计特异性分别为89%(60-98)、93%(71-99)和91%(82-95)。仅对低偏倚风险研究进行的亚分析显示了类似的估计。解释:IgM酶联免疫吸附试验在症状早期的诊断准确性较差。NS1 ELISA具有与RT-PCR相似的诊断准确性,鉴于其相对较低的成本和可获得性,这对全球公共卫生政策具有重要意义。资金:没有。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
求助全文
约1分钟内获得全文 求助全文
来源期刊
Lancet Microbe
Lancet Microbe Multiple-
CiteScore
27.20
自引率
0.80%
发文量
278
审稿时长
6 weeks
期刊介绍: The Lancet Microbe is a gold open access journal committed to publishing content relevant to clinical microbiologists worldwide, with a focus on studies that advance clinical understanding, challenge the status quo, and advocate change in health policy.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:604180095
Book学术官方微信