International Diagnostics Centre Africa, Addis Ababa, Ethiopia.
International Diagnostics Centre, Clinical Research Department, London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.
BMC Infect Dis. 2019 Jul 19;19(1):647. doi: 10.1186/s12879-019-4242-6.
Lassa fever virus has been enlisted as a priority pathogen of epidemic potential by the World Health organization Research and Development (WHO R & D) Blueprint. Diagnostics play a crucial role in epidemic preparedness. This systematic review was conducted to determine the sensitivity and specificity of Lassa fever diagnostic tests for humans.
We searched OVID Medline, OVID Embase, Scopus and Web of Science for laboratory based and field studies that reported the performance of diagnostic tests for Lassa fever in humans from 1 January 1990 to 25 January 2019. Two reviewers independently screened all the studies and included only studies that involved the evaluation of a Lassa fever diagnostic test and provided data on the sensitivity and specificity. The quality of the studies was assessed using the QUADAS-2 criteria. Data on the study location, study design, type of sample, index test, reference tests and diagnostic performance were extracted from the studies.
Out of a total of 1947 records identified, 1245 non-duplicate citations were obtained. Twenty-six (26) full-text articles examined which identified 08 studies meeting pre-defined criteria. Only one study was a field evaluation study. The sensitivity and specificity of the point of care (RDT) against the Nikisins qPCR were 91.2%(95% CI:75.2-97.7) and 86%(95% CI: 71.4-94.2) at temperatures 18-30 °C, while the sensitivity and specificity of the single IgM ELISA assay against standard RT-PCR were 31.1%(95%CI: 25.6-37) and 95.7%(95%CI:92.8-97.7). The sensitivity of the combined ELISA Antigen/IgM assay(against virus isolation), the recombinant IgM/IgG ELISA(against standard RT-PCR), and the IgM/IgG immunoblot(against IFA) were 88%(95%CI:77-95), 25.9%(95%CI:20.8-31.6), and 90.7%(95%CI:84.13-97.27) respectively. The specificity of the combined ELISA Antigen/IgM assay(against virus isolation), the recombinant IgM/IgG ELISA(against standard RT-PCR), and the IgM/IgG immunoblot(against IFA) were 90%(95%CI:88-91), 100%(95%CI:98.2-100), and 96.3%(95%CI:92.2-100) respectively.
Lassa fever has assays for antigenaemia, IgM, IgG and PCR detection. The RDT reportedly performed well but more data are needed from other countries and at temperatures above 30 °C. Most combined immunoassays perform better than the single IgM. Multiplex and pan-Lassa assays are needed. More well conducted field studies are needed.
Prospero registration number: CRD42018091585 .
拉沙热病毒已被世界卫生组织研发（WHO R&D）蓝图列为具有潜在流行潜力的优先病原体。诊断在疫情准备中起着至关重要的作用。本系统评价旨在确定用于人类拉沙热诊断的检测方法的灵敏度和特异性。
我们在 OVID Medline、OVID Embase、Scopus 和 Web of Science 中搜索了从 1990 年 1 月 1 日至 2019 年 1 月 25 日期间发表的关于实验室和现场研究的报告，这些研究报告了人类拉沙热诊断检测的性能。两位评审员独立筛选了所有研究，并仅纳入了评估拉沙热诊断检测方法并提供灵敏度和特异性数据的研究。使用 QUADAS-2 标准评估研究的质量。从研究中提取了有关研究地点、研究设计、样本类型、指标检测、参考检测和诊断性能的数据。
在总共确定的 1947 条记录中，获得了 1245 份非重复引文。对 26 篇（26）全文文章进行了检查，确定了 08 项符合预定义标准的研究。只有一项研究是现场评估研究。即时检测（RDT）与 Nikisins qPCR 的灵敏度和特异性分别为 91.2%（95%CI：75.2-97.7）和 86%（95%CI：71.4-94.2）在 18-30°C 的温度下，而单 IgM ELISA 检测与标准 RT-PCR 的灵敏度和特异性分别为 31.1%（95%CI：25.6-37）和 95.7%（95%CI：92.8-97.7）。联合 ELISA 抗原/IgM 检测（针对病毒分离）、重组 IgM/IgG ELISA（针对标准 RT-PCR）和 IgM/IgG 免疫印迹（针对 IFA）的灵敏度分别为 88%（95%CI：77-95）、25.9%（95%CI：20.8-31.6）和 90.7%（95%CI：84.13-97.27）。联合 ELISA 抗原/IgM 检测（针对病毒分离）、重组 IgM/IgG ELISA（针对标准 RT-PCR）和 IgM/IgG 免疫印迹（针对 IFA）的特异性分别为 90%（95%CI：88-91）、100%（95%CI：98.2-100）和 96.3%（95%CI：92.2-100）。
拉沙热有针对抗原血症、IgM、IgG 和 PCR 检测的检测方法。据报道 RDT 性能良好，但需要来自其他国家和 30°C 以上温度的数据。大多数联合免疫检测的性能优于单一 IgM。需要多重和全拉沙检测方法。需要进行更多精心设计的现场研究。
PROSPERO 注册号：CRD42018091585。
