Performance Characteristics of Four High-Throughput Immunoassays for Detection of IgG Antibodies against SARS-CoV-2
Performance Characteristics of Four High-Throughput Immunoassays for Detection of IgG Antibodies against SARS-CoV-2
复制标题
DOI：
10.1128/jcm.01243-20
复制
发表时间：
2020-08-01
影响因子：
9.4
通讯作者：
Granger, Dane
中科院分区：
文献类型：
--
作者：
Theel, Elitza S.;Harring, Julie;Granger, Dane
随着我们对病毒免疫反应的了解不断深入，严重急性呼吸综合征冠状病毒 2 (SARS-CoV-2) 血清学检测在临床和公共卫生环境中的作用将继续发展。在这里，我们使用来自 56 名 2019 年冠状病毒病确诊患者的一组连续收集的血清样本 (n = 224)，评估了来自 Abbott Laboratories（伊利诺伊州雅培公园）、Epitope Diagnostics, Inc.（加利福尼亚州圣地亚哥）、Euroimmun（德国吕贝克）和 Ortho-Clinical Diagnostics（纽约州罗切斯特）的四项用于检测抗 SARS-CoV-2 IgG 抗体的高通量血清学测试。 (COVID-19)、2018 年的健康供体血清以及 2020 年初收集的交叉反应血清组。在症状出现后 14 天以上或初始逆转录酶 PCR (RT-PCR) 结果呈阳性后收集的恢复期血清样本中，Abbott、Epitope、Euroimmun 和 Ortho-Clinical IgG 检测的灵敏度为 92.9%分别为（78/84）、88.1%（74/84）、97.6%（82/84）和98.8%（83/84）。在特殊的康复期患者中，Abbott、Epitope、Euroimmun 和 Ortho-Clinical 抗 SARS-CoV-2 IgG 检测的敏感性分别为 97.3% (36/37)、73% (27/37)、94.6% (35/37) 和 97.3% (36/37)。对于 Abbott、Epitope、Euroimmun 和 Ortho-Clinical IgG 检测，基于 5% 患病率的总体检测特异性/阳性预测值分别为 99.6%/92.8%、99.6%/90.6%、98.0%/71.2% 和 99.6%/92.5%。总之，我们在恢复期血清中表现出高灵敏度，对 Abbott、Euroimmun 和 Ortho-Clinical 抗 SARS-CoV-2 IgG 检测显示出高特异性。随着用于检测 SARS-CoV-2 抗体的市售血清学检测空前大量涌入，实验室在实施之前必须彻底评估此类检测的准确性。
The role of serologic testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), in both the clinical and public health settings, will continue to evolve as we gain increasing insight into our immune response to the virus. Here, we evaluated four high-throughput serologic tests for detection of anti-SARS-CoV-2 IgG antibodies, from Abbott Laboratories (Abbott Park, IL), Epitope Diagnostics, Inc. (San Diego, CA), Euroimmun (Lubeck, Germany), and Ortho-Clinical Diagnostics (Rochester, NY), using a panel of serially collected serum samples (n = 224) from 56 patients with confirmed coronavirus disease 2019 (COVID-19), healthy donor sera from 2018, and a cross-reactivity serum panel collected in early 2020. The sensitivities of the Abbott, Epitope, Euroimmun, and Ortho-Clinical IgG assays in convalescent-phase serum samples collected more than 14 days post-symptom onset or post-initial positive reverse transcriptase PCR (RT-PCR) result were 92.9% (78/84), 88.1% (74/84), 97.6% (82/84), and 98.8% (83/84), respectively. Among unique convalescent patients, sensitivities of the Abbott, Epitope, Euroimmun, and Ortho-Clinical anti-SARS-CoV-2 IgG assays were 97.3% (36/37), 73% (27/37), 94.6% (35/37), and 97.3% (36/37), respectively. Overall assay specificity/positive predictive values based on a 5% prevalence rate were 99.6%/92.8%, 99.6%/90.6%, 98.0%/71.2%, and 99.6%/92.5%, respectively, for the Abbott, Epitope, Euroimmun, and Ortho-Clinical IgG assays. In conclusion, we show high sensitivity in convalescent-phase sera and high specificity for the Abbott, Euroimmun, and Ortho-Clinical anti-SARS-CoV-2 IgG assays. With the unprecedented influx of commercially available serologic tests for detection of antibodies against SARS-CoV-2, it remains imperative that laboratories thoroughly evaluate such assays for accuracy prior to implementation.