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三种高通量商业化 SARS-CoV-2 抗体检测试剂盒的分析比较揭示了在高发人群中存在微小差异。

Analytic comparison between three high-throughput commercial SARS-CoV-2 antibody assays reveals minor discrepancies in a high-incidence population.

机构信息

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.

出版信息

Sci Rep. 2021 Jun 4;11(1):11837. doi: 10.1038/s41598-021-91235-x.

Abstract

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.

摘要

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。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/44ee/8178338/c8d75ec476bc/41598_2021_91235_Fig1_HTML.jpg

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