Newfoundland and Labrador Public Health Microbiology Laboratory, Division of Laboratory Medicine, Eastern Health, St. John's, Newfoundland and Labrador, Canada.
Faculty of Medicine, Memorial University of Newfoundland, St. John's, Newfoundland and Labrador, Canada.
Viral Immunol. 2021 Apr;34(3):182-189. doi: 10.1089/vim.2020.0199. Epub 2021 Mar 18.
The ability to detect antibodies to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is currently under investigation with various performance characteristics and indications for use. In this article, we analyzed the ability of the Abbott SARS-CoV-2 immunoglobulin class G (IgG), EuroImmun SARS-CoV-2 enzyme-linked immunosorbent assay (ELISA) IgG, and EuroImmun SARS-CoV-2 ELISA immunoglobulin class A (IgA) kits to detect evidence of previous infection with SARS-CoV-2. We tested 49 known coronavirus disease-19 (COVID-19) patients and 111 prepandemic stored serology specimens. This resulted in a sensitivity of 95.9%, 100.0%, and 91.3% and a specificity of 98.2%, 98.2%, and 90.8% respectively, using manufacturer recommended cutoffs after inconclusive results (one for EuroImmun IgG and five for EuroImmun IgA) being excluded in the final statistical analyses. Cross-reactivity of hepatitis C virus seropositive specimens was observed resulting in false positives ( < 0.05). If a two-tiered algorithmic approach was applied, that is, testing with Abbott SARS-CoV-2 assay followed by EuroImmun SARS-CoV-2 IgG, 100% specificity and sensitivity could be obtained after six inconclusive results were excluded from data set before statistical analyses. Performance characteristics presented demonstrate the superior performance of IgG class antibodies for investigating previous infections. In addition, utilizing a second antibody test for supplementary testing may significantly enhance performance, particularly in lower prevalence settings.
目前正在研究各种具有不同性能特征和用途的检测严重急性呼吸综合征冠状病毒 2(SARS-CoV-2)抗体的方法。在本文中,我们分析了 Abbott SARS-CoV-2 免疫球蛋白 G(IgG)、EuroImmun SARS-CoV-2 酶联免疫吸附试验(ELISA)IgG 和 EuroImmun SARS-CoV-2 ELISA 免疫球蛋白 A(IgA)试剂盒检测先前感染 SARS-CoV-2 的能力。我们测试了 49 名已知的冠状病毒病-19(COVID-19)患者和 111 份大流行前储存的血清学标本。在最终的统计分析中排除了不确定结果(EuroImmun IgG 一个,EuroImmun IgA 五个)后,使用制造商推荐的截止值,分别得出了 95.9%、100.0%和 91.3%的灵敏度和 98.2%、98.2%和 90.8%的特异性。丙型肝炎病毒血清阳性标本存在交叉反应,导致假阳性(<0.05)。如果采用两步算法方法,即先用 Abbott SARS-CoV-2 检测,然后用 EuroImmun SARS-CoV-2 IgG 检测,如果在统计分析前排除六个不确定结果,则可获得 100%的特异性和灵敏度。所呈现的性能特征表明 IgG 类抗体在研究先前感染方面具有卓越的性能。此外,利用第二种抗体测试进行补充测试可能会显著提高性能,特别是在低流行率的情况下。