Evaluation of the EUROIMMUN Anti-SARS-CoV-2 ELISA Assay for detection of IgA and IgG antibodies
Evaluation of the EUROIMMUN Anti-SARS-CoV-2 ELISA Assay for detection of IgA and IgG antibodies
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DOI：
10.1016/j.jcv.2020.104468
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发表时间：
2020-08-01
影响因子：
8.8
通讯作者：
Tesic, Vera
中科院分区：
文献类型：
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作者：
Beavis, Kathleen G.;Matushek, Scott M.;Tesic, Vera
随着2019冠状病毒（COVID-19）大流行的演变，开发免疫测定法以帮助确定暴露并可能预测免疫力已成为当务之急。在这份报告中，我们提出了EUROIMMUN酶联免疫吸附试验（ELISA）的性能，半定量检测伊加和IgG抗体的血清和血浆样本使用重组S1结构域的SARS-CoV-2刺突蛋白作为抗原。来自患者的标本，无论是否感染COVID-19，都在芝加哥大学临床微生物学和免疫学实验室进行了检测。在86份SARS-CoV-2 PCR阴性患者样本中，包括28份常见人类冠状病毒株阳性样本，伊加检测结果为76份阴性，10份阳性（88.4%一致性，95%CI：79.9-93.6），IgG检测结果为84份阴性，2份阳性（97.7%一致性，95%CI：91.9-99.6）。在来自SARS-CoV-2 PCR阳性患者的82份样本中，14份IgA检测结果为阴性，68份伊加检测结果为阳性（82.9%一致性，95%CI：73.4-89.5），而27份IgG检测结果为阴性，55份IgG检测结果为阳性（67.1%一致性，95%CI：56.3-76.3）。在PCR阳性后>= 4天收集的样本中，42份样本中有38份（90.5%一致性，95% CI：77.9-96.2）为伊加阳性，42份样本中有42份（100%一致性，95% CI：91.6-100）为IgG阳性。EUROIMMUN Anti-SARS-CoV-2 ELISA检测试剂盒在通过PCR诊断COVID-19后>= 4天采集的样本中显示出良好的伊加检测灵敏度和极好的IgG抗体检测灵敏度。该检测方法对伊加表现出良好的特异性，对IgG表现出优异的特异性，并且在28例常见人冠状病毒感染患者（NL 63型和OC 43型）的2例样本中仅表现出临界交叉反应。
As the Coronavirus 2019 (COVID-19) pandemic evolves, the development of immunoassays to help determine exposure and potentially predict immunity has become a pressing priority. In this report we present the performance of the EUROIMMUN enzyme-linked immunosorbent assay (ELISA) for semi-quantitative detection of IgA and IgG antibodies in serum and plasma samples using recombinant S1 domain of the SARS-CoV-2 spike protein as antigen. Specimens from patients, with and without COVID-19 infection, were tested at the University of Chicago Clinical Microbiology and Immunology Laboratory. Of 86 samples from SARS-CoV-2 PCR-negative patients, including 28 samples positive for common human coronavirus strains, 76 tested negative and 10 tested positive for IgA (88.4% agreement, 95% CI: 79.9-93.6) while 84 tested negative and 2 tested positive for IgG (97.7% agreement, 95% CI: 91.9-99.6). Of 82 samples from SARS-CoV-2 PCR-positive patients, 14 tested negative and 68 tested positive for IgA (82.9% agreement, 95% CI: 73.4-89.5) while 27 tested negative and 55 tested positive for IgG (67.1% agreement, 95% CI: 56.3-76.3). Of samples collected >= 4 days after positive PCR, 38 of 42 (90.5% agreement, 95% CI: 77.9-96.2) were positive for IgA, and 42 of 42 (100% agreement, 95% CI: 91.6-100) were positive for IgG, respectively. The EUROIMMUN Anti-SARS-CoV-2 ELISA Assay demonstrated good sensitivity for detection of IgA and excellent sensitivity for detection of IgG antibodies from samples collected >= 4 days, after COVID-19 diagnosis by PCR. This assay demonstrated good specificity for IgA and excellent specificity for IgG and demonstrated only borderline cross reaction in 2 of the 28 samples from patients with common human coronaviruses infection, types NL63 and OC43.