Microbiology Department, Laboratoire Hospitalier Universitaire de Bruxelles - Universitair Laboratorium Brussel (LHUB-ULB), Université Libre de Bruxelles, Brussels, Belgium.
Department of Clinical Biochemistry, Cliniques Universitaires Saint-Luc, UCLouvain (CUSL), Avenue Hippocrate 10, 1200, Brussels, Belgium.
J Clin Virol. 2020 Jul;128:104413. doi: 10.1016/j.jcv.2020.104413. Epub 2020 May 5.
Several SARS-CoV-2 immunoassays have been developed recently. The purpose of this study was to assess the performance of five immunoassays for the detection of SARS-CoV-2 antibodies.
Two quantitative automated immunoassays (Maglumi™2019-n-Cov IgG and IgM and Euroimmun Anti-SARS-CoV-2 IgG and IgA assays) and three lateral flow rapid tests were performed. This retrospective study included 200 residual sera from patients and healthy volunteers. Case serum samples (n = 128) were obtained from COVID-19 patients confirmed by RT-qPCR and CT-scan. Days since onset of symptoms was collected from their medical records. Control non-SARS-CoV-2 samples (n = 72) were obtained from anonymous stored residual serum samples.
Maglumi™ IgG/IgM tests showed overall less sensitivity than Euroimmun IgG/IgA test (84.4 % versus 64.3 %). Both tests showed similar specificities of IgG at 99 % and 100 %, respectively. The results from the lateral flow assays were easily interpretable with unambiguous coloured reading bands. The overall sensitivity of the three tests was similar (around 70 %) without any significant differences. The sensitivity of the three lateral flow assays and also of the serological quantitative assays increased during the second week after symptom onset and all reached similar values (91 %-94 %) after 14 days.
This study shows accurate and equivalent performance of the five serological antibody assays (ELISA, CLIA and three lateral flow tests) in detecting SARS-CoV-2 antibodies 14 days after the onset of COVID-19 symptoms. This is compatible with their application in specific clinical contexts and in determining epidemiological strategies for the COVID-19 pandemic.
最近已经开发了几种 SARS-CoV-2 免疫测定法。本研究的目的是评估五种免疫测定法检测 SARS-CoV-2 抗体的性能。
进行了两种定量自动化免疫测定法（Maglumi™2019-n-Cov IgG 和 IgM 以及 Euroimmun Anti-SARS-CoV-2 IgG 和 IgA 测定法）和三种侧向流动快速检测法。这项回顾性研究包括 200 份来自患者和健康志愿者的剩余血清。病例血清样本（n = 128）取自通过 RT-qPCR 和 CT 扫描确诊为 COVID-19 的患者。从病历中收集了症状出现后的天数。非 SARS-CoV-2 对照样本（n = 72）取自匿名存储的剩余血清样本。
Maglumi™IgG/IgM 检测法的总体敏感性低于 Euroimmun IgG/IgA 检测法（84.4%对 64.3%）。两种检测法的 IgG 特异性相似，分别为 99%和 100%。侧向流动检测法的结果易于解释，有色读取带清晰明确。三种检测法的总体敏感性相似（约 70%），无明显差异。三种侧向流动检测法以及血清学定量检测法的敏感性在症状出现后第二周增加，14 天后均达到相似值（91%-94%）。
本研究表明，在 COVID-19 症状出现 14 天后，五种血清学抗体检测法（ELISA、CLIA 和三种侧向流动检测法）在检测 SARS-CoV-2 抗体方面具有准确且等效的性能。这与其在特定临床环境中的应用以及确定 COVID-19 大流行的流行病学策略兼容。
