Pillay Kamla, Keddie Suzanne H, Fitchett Elizabeth, Akinde Cassandra, Bärenbold Oliver, Bradley John, Falconer Jane, Keogh Ruth H, Lim Zhia Ning, Nezafat Maldonado Behrouz, Maynard-Smith Laura, Sugrue Ellen, Taylor Okuda, Hopkins Heidi, Dubot-Pérès Audrey
Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, UK.
Faculty of Epidemiology and Population Health, London School of Hygiene & Tropical Medicine, London, UK.
Lancet Microbe. 2025 Jul;6(7):101088. doi: 10.1016/j.lanmic.2025.101088. Epub 2025 Apr 7.
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.
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).
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.
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.
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登革热被世界卫生组织列为全球十大健康威胁之一。及时识别登革病毒可指导临床管理和疫情应对，但实验室诊断复杂、成本高，且在性能评估方面缺乏共识。本系统评价旨在提供可靠的诊断准确性估计值，以指导全球指南制定并评估新型快速诊断测试。
在本系统评价和荟萃分析中，我们于2021年2月16日在九个文献数据库中检索了关于登革热感染的五种常见参考测试的报告：NS1酶联免疫吸附测定（ELISA）、IgM ELISA、IgG ELISA、逆转录聚合酶链反应（RT-PCR）和病毒中和试验。如果文章报告了来自五名以上参与者的原始数据，以完成将这些测试之一（对人血清）与任何对照进行比较的2×2列联表，则纳入研究。使用贝叶斯随机效应荟萃分析估计诊断准确性，该分析不需要金标准对照。使用QUADAS-2评估偏倚风险。本评价已在国际前瞻性系统评价注册库（PROSPERO）注册（注册号：CRD42022341552）。
从161篇文章中提取数据，从而能够分析三种感兴趣测试的多个时间范围。RT-PCR（症状出现后0至4天）、NS1 ELISA（0至4天）和IgM ELISA（1至7天）的合并敏感性分别为95%（95%可信区间77%至99%）、90%（68%至98%）和71%（57%至84%）。相应的合并特异性估计值分别为89%（60%至98%）、93%（71%至99%）和91%（82%至95%）。仅对低偏倚风险研究的亚分析显示了相似的估计值。
IgM ELISA在症状病程早期显示出较差的诊断准确性。NS1 ELISA显示出与RT-PCR相似的诊断准确性，鉴于其成本相对较低且易于获得，这对全球公共卫生政策具有重要意义。
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