使用冠状病毒病2019(COVID-19)血清学检测来诊断急性感染或确定人群血清阳性率取决于了解早期感染期间的测定准确性。我们旨在通过提供从症状发作开始的时间的敏感性和特异性估计来评估COVID-19血清学检测的诊断性能。
对OvidMEDLINE的系统搜索,Embase,Cochrane中央对照试验登记册(CENTRAL)和PubMed于2020年5月13日进行。所有英语语言,纳入了经同行评审的原始出版物,报告了血清学检测相对于病毒学证实的SARS-CoV-2感染的诊断性能.
我们的搜索产生了599种独特的出版物。共有39份出版物报告来自8872名参与者的11.516个样本符合纳入我们研究的资格标准。在第7、14、21、28天和第28天之后,IgM和IgG血清转化的总百分比为37.5%,73.3%,81.3%,72.3%和73.3%,和35.4%,80.6%,93.3%,84.4%和98.9%,分别。到第21天,IgM敏感性的汇总估计为0.872(95%CI:0.784-0.928)和特异性0.973(95%CI:0.938-0.988),而IgG敏感性为0.913(95%CI:0.823-0.959),特异性为0.960(95%CI:0.919-0.980)。关于元回归,与其他方法相比,使用酶联免疫吸附测定(ELISA)的IgM和IgG测试准确性在第14天明显更高。
血清学测定为急性SARS-CoV-2感染的诊断提供了不完美的敏感性。在爆发期间或之后不久,对人群血清阳性率的估计将需要针对感染之间的延迟进行调整。症状发作和血清转换。
The use of coronavirus disease 2019 (COVID-19) serological testing to diagnose acute infection or determine population seroprevalence relies on understanding assay accuracy during early infection. We aimed to evaluate the diagnostic performance of serological testing in COVID-19 by providing summary sensitivity and specificity estimates with time from symptom onset.
A systematic search of Ovid MEDLINE, Embase, Cochrane Central Register of Controlled Trials (CENTRAL) and PubMed was performed up to May 13, 2020. All English language, original peer-reviewed publications reporting the diagnostic performance of serological testing vis-à-vis virologically confirmed SARS-CoV-2 infection were included.
Our search yielded 599 unique publications. A total of 39 publications reporting 11 516 samples from 8872 human participants met eligibility criteria for inclusion in our study. Pooled percentages of IgM and IgG seroconversion by Day 7, 14, 21, 28 and after Day 28 were 37.5%, 73.3%, 81.3%, 72.3% and 73.3%, and 35.4%, 80.6%, 93.3%, 84.4% and 98.9%, respectively. By Day 21, summary estimate of IgM sensitivity was 0.872 (95% CI: 0.784-0.928) and specificity 0.973 (95% CI: 0.938-0.988), while IgG sensitivity was 0.913 (95% CI: 0.823-0.959) and specificity 0.960 (95% CI: 0.919-0.980). On meta-regression, IgM and IgG test accuracy was significantly higher at Day 14 using enzyme-linked immunosorbent assay (ELISA) compared to other methods.
Serological assays offer imperfect sensitivity for the diagnosis of acute SARS-CoV-2 infection. Estimates of population seroprevalence during or shortly after an outbreak will need to adjust for the delay between infection, symptom onset and seroconversion.