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用八种市售免疫测定法定量 SARS-CoV-2 抗体。

Quantification of SARS-CoV-2 antibodies with eight commercially available immunoassays.

机构信息

Austrian Red Cross, Blood Service for Vienna, Lower Austria and Burgenland, Wiedner Haupstraße 32, A-1040 Vienna, Austria.

Austrian Red Cross, Blood Service for Vienna, Lower Austria and Burgenland, Wiedner Haupstraße 32, A-1040 Vienna, Austria.

出版信息

J Clin Virol. 2020 Aug;129:104540. doi: 10.1016/j.jcv.2020.104540. Epub 2020 Jul 6.

Abstract

Since the emergence of SARS-CoV-2 numerous antibody assays have become available, demonstrating different performance characteristics. This study focused on a quantitative correlation between different commercial assays and a neutralization test (NT). Comparative data is needed as a basis for the production of convalescent plasma and potential interpretations COVID-19 immunity. Sera of 100 SARS-CoV-2 convalescent plasma donors were collected and SARS-CoV-2 antibodies were characterized using three different IgG-ELISAs (EUROIMMUN IgG and NCP-IgG ELISA, Wantai ELISA), two CLIA (Elecsys, LIAISON) and two lateral flow tests (MEDsan IgM/IgG-Rapid-Test, Wantai Rapid Test) and subsequently correlated to neutralization titers. The Wantai ELISA and the Elecsys provide the highest sensitivities in this sample (98 and 95 percent respectively). Titers with the best overall quantitative correlation to the NT titer were obtained with the Euroimmun IgG ELISA assay (Rho=0.759) and the Wantai ELISA assay (Rho=0.729). An infection without fever and negative or weakly positive reactions in the Wantai Rapid test were negative predictive factors for NT titers >1:200 (negative predictive value of 92 % and 92 % respectively, combination of both 100 %). The Wantai ELISA titer could be a suitable substitute for NT. An adequate pooling strategy of plasma units additionally could compensate deviations of individual antibody titers.

摘要

自 SARS-CoV-2 出现以来,已经有许多抗体检测方法问世,这些方法具有不同的性能特点。本研究侧重于不同商业检测方法与中和检测(NT)之间的定量相关性。需要比较数据作为生产恢复期血浆和潜在解释 COVID-19 免疫的基础。收集了 100 名 SARS-CoV-2 恢复期血浆供体的血清,并使用三种不同的 IgG-ELISA(EUROIMMUN IgG 和 NCP-IgG ELISA、万泰 ELISA)、两种 CLIA(Elecsys、LIAISON)和两种侧向流动测试(MEDsan IgM/IgG-Rapid-Test、万泰快速测试)来检测 SARS-CoV-2 抗体,并随后与中和滴度进行相关性分析。在该样本中,万泰 ELISA 和 Elecsys 提供了最高的灵敏度(分别为 98%和 95%)。与 NT 滴度具有最佳整体定量相关性的滴度是通过 EUROIMMUN IgG ELISA 检测法(Rho=0.759)和万泰 ELISA 检测法(Rho=0.729)获得的。没有发热和万泰快速检测呈阴性或弱阳性的感染是 NT 滴度>1:200 的阴性预测因素(阴性预测值分别为 92%和 92%,两者结合的阴性预测值为 100%)。万泰 ELISA 滴度可以作为 NT 的替代物。另外,适当的血浆单位汇集策略可以补偿单个抗体滴度的偏差。

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