文献检索，用中文搜 PubMed

BACKGROUND

Chikungunya virus (CHIKV) causes febrile illnesses and has always been misdiagnosed as other viral infections, such as dengue and Zika; thus, a laboratory test is needed. Serological tests are commonly used to diagnose CHIKV infection, but their accuracy is questionable due to varying degrees of reported sensitivities and specificities. Herein, we conducted a systematic review and meta-analysis to evaluate the diagnostic accuracy of serological tests currently available for CHIKV.

METHODOLOGY AND PRINCIPAL FINDINGS

A literature search was performed in PubMed, CINAHL Complete, and Scopus databases from the 1st December 2020 until 22nd April 2021. Studies reporting sensitivity and specificity of serological tests against CHIKV that used whole blood, serum, or plasma were included. QUADAS-2 tool was used to assess the risk of bias and applicability, while R software was used for statistical analyses. Thirty-five studies were included in this meta-analysis; 72 index test data were extracted and analysed. Rapid and ELISA-based antigen tests had a pooled sensitivity of 85.8% and 82.2%, respectively, and a pooled specificity of 96.1% and 96.0%, respectively. According to our meta-analysis, antigen detection tests serve as a good diagnostic test for acute-phase samples. The IgM detection tests had more than 90% diagnostic accuracy for ELISA-based tests, immunofluorescence assays, in-house developed tests, and samples collected after seven days of symptom onset. Conversely, low sensitivity was found for the IgM rapid test (42.3%), commercial test (78.6%), and for samples collected less than seven of symptom onset (26.2%). Although IgM antibodies start to develop on day 2 of CHIKV infection, our meta-analysis revealed that the IgM detection test is not recommended for acute-phase samples. The diagnostic performance of the IgG detection tests was more than 93% regardless of the test formats and whether the test was commercially available or developed in-house. The use of samples collected after seven days of symptom onset for the IgG detection test suggests that IgG antibodies can be detected in the convalescent-phase samples. Additionally, we evaluated commercial IgM and IgG tests for CHIKV and found that ELISA-based and IFA commercial tests manufactured by Euroimmun (Lübeck, Germany), Abcam (Cambridge, UK), and Inbios (Seattle, WA) had diagnostic accuracy of above 90%, which was similar to the manufacturers' claim.

CONCLUSION

Based on our meta-analysis, antigen or antibody-based serological tests can be used to diagnose CHIKV reliably, depending on the time of sample collection. The antigen detection tests serve as a good diagnostic test for samples collected during the acute phase (≤7 days post symptom onset) of CHIKV infection. Likewise, IgM and IgG detection tests can be used for samples collected in the convalescent phase (>7 days post symptom onset). In correlation to the clinical presentation of the patients, the combination of the IgM and IgG tests can differentiate recent and past infections.

BACKGROUND

METHODOLOGY AND PRINCIPAL FINDINGS

CONCLUSION

背景

基孔肯雅病毒（CHIKV）会引起发热疾病，并且一直被误诊为其他病毒感染，如登革热和寨卡病毒；因此，需要进行实验室检测。血清学检测常用于诊断 CHIKV 感染，但由于报道的敏感性和特异性存在不同程度的差异，其准确性值得怀疑。在此，我们进行了一项系统评价和荟萃分析，以评估目前用于 CHIKV 的血清学检测的诊断准确性。

方法和主要发现

从 2020 年 12 月 1 日至 2021 年 4 月 22 日，我们在 PubMed、CINAHL Complete 和 Scopus 数据库中进行了文献检索。纳入了使用全血、血清或血浆检测针对 CHIKV 的血清学检测的敏感性和特异性的研究。使用 QUADAS-2 工具评估偏倚和适用性风险，而 R 软件用于统计分析。本荟萃分析纳入了 35 项研究；提取并分析了 72 项指标检测数据。快速和基于 ELISA 的抗原检测的敏感性分别为 85.8%和 82.2%，特异性分别为 96.1%和 96.0%。根据我们的荟萃分析，抗原检测试验是急性样本的良好诊断检测方法。针对 ELISA 检测、免疫荧光检测、内部开发的检测以及发病后 7 天采集的样本，IgM 检测试验的诊断准确率超过 90%。相反，IgM 快速检测试验（42.3%）、商业检测试验（78.6%）和发病后 7 天内采集的样本的敏感性较低（26.2%）。尽管 IgM 抗体在 CHIKV 感染的第 2 天开始产生，但我们的荟萃分析表明，IgM 检测试验不推荐用于急性样本。无论检测形式如何，以及检测是商业化的还是内部开发的，IgG 检测试验的诊断性能均超过 93%。针对 IgG 检测试验，在发病后 7 天采集样本表明 IgG 抗体可在恢复期样本中检测到。此外，我们评估了用于 CHIKV 的商业 IgM 和 IgG 检测，发现基于 ELISA 和免疫荧光分析的由 Euroimmun（德国吕贝克）、Abcam（英国剑桥）和 Inbios（华盛顿州西雅图）制造的商业 IgM 和 IgG 检测具有超过 90%的诊断准确性，与制造商的宣称相似。