Clinical evaluation of serological IgG antibody response on the Abbott Architect for established SARS-CoV-2 infection
Clinical evaluation of serological IgG antibody response on the Abbott Architect for established SARS-CoV-2 infection
复制标题
DOI：
10.1016/j.cmi.2020.05.036
复制
发表时间：
2020-09-01
影响因子：
14.2
通讯作者：
Sethi, S. K.
中科院分区：
文献类型：
--
作者：
Chew, K. L.;Tan, S. S.;Sethi, S. K.
目的：本研究旨在评估Abbott Architect SARS-CoV-2 IgG检测试剂盒在COVID-19患者中的诊断性能。方法：使用Abbott SARS-CoV-2 IgG检测试剂盒（Abbott Diagnostics，芝加哥，美国）检测177例有症状的SARS-CoV-2阳性患者和163例非COVID-19患者的残留血清中的抗体。结果：该方法的特异性为100.0%（95%CI：97.1-100.0%）。该检测试剂盒的临床灵敏度随症状发作的时间而变化，随着临床疾病发作时间的延长而增加。第21天的临床敏感性为84.4%（27/ 32; 95%CI：66.5-94.1%）。≥ 14天组的临床敏感性高于≥ 21天组，这两组（≥ 14天组）的联合临床敏感性为84.2%（49/57; 71.6e92.1%）。在疾病的早期阶段，临床敏感性有限，但从临床症状发作后14天开始改善。(C)2020年欧洲临床微生物学和传染病学会。由爱思唯尔有限公司出版。保留所有权利。
Objective: This study aimed to evaluate the diagnostic performance of the Abbott Architect SARS-CoV-2 IgG assay in COVID-19 patients.Methods: Residual sera from 177 symptomatic SARS-CoV-2-positive patients and 163 non-COVID-19 patients were tested for antibody with the Abbott SARS-CoV-2 IgG assay (Abbott Diagnostics, Chicago, USA). Clinical records for COVID-19 patients were reviewed to determine the time from onset of clinical illness to testing.Results: Specificity of the assay was 100.0% (95%CI: 97.1-100.0%). The clinical sensitivity of the assay varied depending on time from onset of symptoms, increasing with longer periods from the onset of clinical illness. The clinical sensitivity at = 21 days 84.4% (27/ 32; 95%CI: 66.5-94.1%). Clinical sensitivity was higher in the >= 14-day group compared to = 21-days groups; the combined clinical sensitivity for these groups (>= 14 days) was 84.2% (49/57; 71.6e92.1%).Conclusion: The Abbott SARS-CoV-2 IgG test has high specificity. Clinical sensitivity was limited in the early stages of disease but improved from 14 days after the onset of clinical symptoms. (C) 2020 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.