Biomedical Research Center, QU Health, Qatar University, 2713, Doha, Qatar.
Department of Biomedical Science, College of Health Sciences, QU Health, Qatar University, Women's Science building, C01, P.O Box: 2713, Doha, Qatar.
Sci Rep. 2021 Jun 4;11(1):11837. doi: 10.1038/s41598-021-91235-x.
Performance of three automated commercial serological IgG-based assays was investigated for assessing SARS-CoV-2 "ever" (past or current) infection in a population-based sample in a high exposure setting. PCR and serological testing was performed on 394 individuals. SARS-CoV-2-IgG seroprevalence was 42.9% (95% CI 38.1-47.8%), 40.6% (95% CI 35.9-45.5%), and 42.4% (95% CI 37.6-47.3%) using the CL-900i, VidasIII, and Elecsys assays, respectively. Between the three assays, overall, positive, and negative percent agreements ranged between 93.2-95.7%, 89.3-92.8%, and 93.8-97.8%, respectively; Cohen's kappa statistic ranged from 0.86 to 0.91; and 35 specimens (8.9%) showed discordant results. Among all individuals, 12.5% (95% CI 9.6-16.1%) had current infection, as assessed by PCR. Of these, only 34.7% (95% CI 22.9-48.7%) were seropositive by at least one assay. A total of 216 individuals (54.8%; 95% CI 49.9-59.7%) had evidence of ever infection using antibody testing and/or PCR during or prior to this study. Of these, only 78.2%, 74.1%, and 77.3% were seropositive in the CL-900i, VidasIII, and Elecsys assays, respectively. All three assays had comparable performance and excellent agreement, but missed at least 20% of individuals with past or current infection. Commercial antibody assays can substantially underestimate ever infection, more so when infection rates are high.
三种商业化的基于 IgG 的血清学自动分析系统在高暴露环境下的人群中进行了 SARS-CoV-2 既往(过去或现在)感染评估。对 394 人进行了 PCR 和血清学检测。CL-900i、VidasIII 和 Elecsys 检测的 SARS-CoV-2-IgG 血清阳性率分别为 42.9%(95%CI 38.1-47.8%)、40.6%(95%CI 35.9-45.5%)和 42.4%(95%CI 37.6-47.3%)。三种检测方法的总符合率、阳性符合率和阴性符合率分别为 93.2-95.7%、89.3-92.8%和 93.8-97.8%;Cohen's kappa 统计量为 0.86-0.91;35 份标本(8.9%)显示不一致的结果。在所有个体中,12.5%(95%CI 9.6-16.1%)根据 PCR 检测为现症感染。其中,只有 34.7%(95%CI 22.9-48.7%)至少有一种检测方法呈血清阳性。在这项研究期间或之前,使用抗体检测和/或 PCR 检测,共有 216 人(54.8%;95%CI 49.9-59.7%)有既往感染的证据。其中,CL-900i、VidasIII 和 Elecsys 检测的血清阳性率分别为 78.2%、74.1%和 77.3%。三种检测方法均具有良好的性能和一致性,但至少有 20%的既往或现症感染个体被漏检。商业抗体检测可能会大大低估既往感染,尤其是在感染率较高时。