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

Quantification of SARS-CoV-2 antibodies with eight commercially available immunoassays
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DOI:
10.1016/j.jcv.2020.104540
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发表时间:
2020-08-01
影响因子:
8.8
通讯作者:
Jungbauer, Christof
Jungbauer, Christof
中科院分区:
医学3区
文献类型:
--
作者:
Weidner, Lisa;Gaensdorfer, Simon;Jungbauer, Christof

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自SARS-CoV-2出现以来,大量的抗体检测方法应运而生,表现出不同的性能特点。这项研究集中在不同的商业检测和中和试验(NT)之间的定量相关性。收集100例SARS-CoV-2恢复期献血员血清,用三种不同的免疫球蛋白抗体(EUROIMMON-Ig G和NCP-Ig G EL ISA,万泰EL ISA)、两种CLIA(电泳法、联络法)和两种侧向流动试验(MEDSan Ig M/Ig G快速检测、万泰快速检测)对SARS-CoV-2抗体进行鉴定,并与中和效价相关。万泰ELISA法和ELECTYS法的敏感性最高(分别为98%和95%)。与NT滴度总体定量相关性最好的是Euroimmun Ig G EL ISA法(Rho=0.759)和万泰EL ISA法(Rho=0.729),无发热和万泰快速试验阴性或弱阳性反应是NT滴度的阴性预测因素(阴性预测值分别为92%和92%,两者均为100%),万泰EL ISA效价可作为NT的合适替代品。适当的血浆单位共享策略还可以补偿单个抗体滴度的偏差。
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.