Department of Clinical Biology, Laboratory of Microbiology, Universitair Ziekenhuis Brussel, Vrije Universiteit Brussel, 1090 Brussels, Belgium.
Department of Clinical Biology, Laboratory of Microbiology, Universitair Ziekenhuis Brussel, Vrije Universiteit Brussel, 1090 Brussels, Belgium.
Diagn Microbiol Infect Dis. 2021 May;100(1):115313. doi: 10.1016/j.diagmicrobio.2021.115313. Epub 2021 Jan 19.
To evaluate the diagnostic performances of four SARS-CoV-2 IgG antibody immunoassays.
Following immunoassays were studied: Abbott's SARS-CoV-2 IgG assay, Diasorin's Liaison SARS-CoV-2 S2/S2 IgG assay, Euroimmun's Anti-SARS-CoV-2 IgG ELISA, and Roche's Elecsys Anti-SARS-CoV-2 assay. Specificity was retrospectively evaluated with 38 samples from 2019. Sensitivity samples (n = 147) were taken from SARS-CoV-2 real-time PCR-positive patients who developed COVID-19 symptoms ten days earlier.
Mean specificity was 96.6%. Mean sensitivity was 62.7% from ten days after onset of symptoms, 84.4% from 15 days after onset of symptoms, and 87.5% from 20 days after onset of symptoms.
Specificity was high, while Abbott and Roche were 100% specific. Sensitivity increased over time, with Abbott and Roche having the highest sensitivity at all time points with ≥90% from 20 days after symptoms' onset. These findings may assist in selecting SARS-CoV-2 IgG antibody immunoassays for additional diagnostics, epidemiological research, and vaccine development.
评估四种 SARS-CoV-2 IgG 抗体免疫测定的诊断性能。
研究了以下免疫测定：雅培 SARS-CoV-2 IgG 测定、DiaSorin Liaison SARS-CoV-2 S2/S2 IgG 测定、欧蒙 Anti-SARS-CoV-2 IgG ELISA 以及罗氏 Elecsys Anti-SARS-CoV-2 测定。使用 2019 年的 38 份样本对特异性进行了回顾性评估。敏感性样本（n=147）取自 COVID-19 症状出现 10 天前 SARS-CoV-2 实时 PCR 阳性的患者。
平均特异性为 96.6%。从症状出现后 10 天开始，平均敏感性为 62.7%，从症状出现后 15 天开始为 84.4%，从症状出现后 20 天开始为 87.5%。
特异性较高，雅培和罗氏的特异性均为 100%。敏感性随时间推移而增加，雅培和罗氏在所有时间点的敏感性最高，从症状出现后 20 天开始均≥90%。这些发现可能有助于选择 SARS-CoV-2 IgG 抗体免疫测定以进行额外的诊断、流行病学研究和疫苗开发。
