Kontou Panagiota I, Braliou Georgia G, Dimou Niki L, Nikolopoulos Georgios, Bagos Pantelis G
Department of Computer Science and Biomedical Informatics, University of Thessaly, Papasiopoulou 2-4, 35131 Lamia, Greece.
International Agency for Research on Cancer, 69372 Lyon, France.
Diagnostics (Basel). 2020 May 19;10(5):319. doi: 10.3390/diagnostics10050319.
The emergence of Coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 made imperative the need for diagnostic tests that can identify the infection. Although Nucleic Acid Test (NAT) is considered to be the gold standard, serological tests based on antibodies could be very helpful. However, individual studies are usually inconclusive, thus, a comparison of different tests is needed. We performed a systematic review and meta-analysis in PubMed, medRxiv and bioRxiv. We used the bivariate method for meta-analysis of diagnostic tests pooling sensitivities and specificities. We evaluated IgM and IgG tests based on Enzyme-linked immunosorbent assay (ELISA), Chemiluminescence Enzyme Immunoassays (CLIA), Fluorescence Immunoassays (FIA), and the Lateral Flow Immunoassays (LFIA). We identified 38 studies containing data from 7848 individuals. Tests using the S antigen are more sensitive than N antigen-based tests. IgG tests perform better compared to IgM ones and show better sensitivity when the samples were taken longer after the onset of symptoms. Moreover, a combined IgG/IgM test seems to be a better choice in terms of sensitivity than measuring either antibody alone. All methods yield high specificity with some of them (ELISA and LFIA) reaching levels around 99%. ELISA- and CLIA-based methods perform better in terms of sensitivity (90%-94%) followed by LFIA and FIA with sensitivities ranging from 80% to 89%. ELISA tests could be a safer choice at this stage of the pandemic. LFIA tests are more attractive for large seroprevalence studies but show lower sensitivity, and this should be taken into account when designing and performing seroprevalence studies.
由严重急性呼吸综合征冠状病毒 2 型（SARS-CoV-2）引起的 2019 冠状病毒病（COVID-19）的出现，使得开发能够识别该感染的诊断检测方法变得至关重要。尽管核酸检测（NAT）被认为是金标准，但基于抗体的血清学检测可能会非常有帮助。然而，个别研究通常没有定论，因此，需要对不同检测方法进行比较。我们在 PubMed、medRxiv 和 bioRxiv 上进行了系统评价和荟萃分析。我们使用双变量方法对诊断检测的敏感性和特异性进行荟萃分析。我们评估了基于酶联免疫吸附测定（ELISA）、化学发光酶免疫测定（CLIA）、荧光免疫测定（FIA）和侧向流动免疫测定（LFIA）的 IgM 和 IgG 检测。我们确定了 38 项研究，其中包含来自 7848 名个体的数据。使用 S 抗原的检测比基于 N 抗原的检测更敏感。与 IgM 检测相比，IgG 检测表现更好，并且在症状出现后较长时间采集样本时显示出更高的敏感性。此外，就敏感性而言，联合 IgG/IgM 检测似乎比单独检测任一抗体是更好的选择。所有方法都具有较高的特异性，其中一些方法（ELISA 和 LFIA）的特异性达到了约 99%。基于 ELISA 和 CLIA 的方法在敏感性方面表现更好（90%-94%），其次是 LFIA 和 FIA，敏感性范围为 80%至 89%。在疫情的这个阶段，ELISA 检测可能是更安全的选择。LFIA 检测对于大型血清流行率研究更具吸引力，但敏感性较低，在设计和进行血清流行率研究时应考虑到这一点。
