Laboratory Diagnostic Center, University Hospital RWTH Aachen, Germany.
Department of Pneumology and Intensive Care Medicine, University Hospital RWTH Aachen, Germany.
J Clin Virol. 2020 Jul;128:104394. doi: 10.1016/j.jcv.2020.104394. Epub 2020 Apr 29.
Facing the ongoing pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), there is an urgent need for serological assays identifying individuals with past coronavirus disease 2019 (COVID-19).
Our study is the first to compare four new commercially available assays using 75 sera from patients tested positive or negative by SARS-CoV-2 PCR: the anti SARS-CoV-2 ELISA (IgG) (Euroimmun, Germany), the EDI New Coronavirus COVID-19 IgG ELISA, (Epitope diagnostics (EDI), USA), the recomWell SARS-CoV-2 IgG ELISA (Mikrogen, Germany), and the SARS-CoV-2 Virachip IgG (Viramed, Germany).
We found a sensitivity of 86.4 %, 100 %, 86.4 %, and 77.3 % and a specificity of 96,2 %, 88,7 %, 100 %, and 100 % for the Euroimmun assay, the EDI assay, the Mikrogen assay, and the Viramed assay, respectively.
Commercially available SARS-CoV-2 IgG assays have a sufficient specificity and sensitivity for identifying individuals with past SARS-CoV-2 infection.
面对由严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）引起的持续大流行，迫切需要血清学检测方法来识别过去患有 2019 年冠状病毒病（COVID-19）的个体。
我们的研究首次比较了四种新的商业上可用的检测方法，这些方法使用了 75 份经 SARS-CoV-2 PCR 检测呈阳性或阴性的患者血清：抗 SARS-CoV-2 ELISA（IgG）（德国 Euroimmun）、EDI 新型冠状病毒 COVID-19 IgG ELISA、（Epitope diagnostics (EDI)，美国）、recomWell SARS-CoV-2 IgG ELISA（德国 Mikrogen）和 SARS-CoV-2 Virachip IgG（德国 Viramed）。
我们发现 Euroimmun 检测法的敏感性为 86.4%、100%、86.4%和 77.3%，特异性为 96.2%、88.7%、100%和 100%，EDI 检测法、Mikrogen 检测法和 Viramed 检测法分别为。
商业上可用的 SARS-CoV-2 IgG 检测方法对于识别过去感染 SARS-CoV-2 的个体具有足够的特异性和敏感性。
