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评估 PCR 阳性患者的 SARS-CoV-2 IgG 抗体反应:九种检测方法与临床数据的比较。

Evaluation of SARS-CoV-2 IgG antibody response in PCR positive patients: Comparison of nine tests in relation to clinical data.

机构信息

SYNLAB Estonia, Tallinn, Estonia.

Department of Microbiology, Institute of Biomedicine and Translational Medicine, University of Tartu, Tartu, Estonia.

出版信息

PLoS One. 2020 Oct 27;15(10):e0237548. doi: 10.1371/journal.pone.0237548. eCollection 2020.

Abstract

SARS-CoV-2 antibody tests are available in various formats, detecting different viral target proteins and antibody subclasses. The specificity and sensitivity of SARS-CoV-2 antibody tests are known to vary and very few studies have addressed the performance of these tests in COVID-19 patient groups at different time points. We here compared the sensitivity and specificity of seven commercial (SNIBE, Epitope, Euroimmun, Roche, Abbott, DiaSorin, Biosensor) and two in-house LIPS assays (LIPS N and LIPS S-RBD) IgG/total Ab tests in serum samples from 97 COVID-19 patients and 100 controls, and correlated the results with the patients' clinical data and the time-point the test was performed. We found a remarkable variation in the sensitivity of antibody tests with the following performance: LIPS N (91.8%), Epitope (85.6%), Abbott and in-house LIPS S-RBD (both 84.5%), Roche (83.5%), Euroimmun (82.5%), DiaSorin (81.4%), SNIBE (70.1%), and Biosensor (64.9%). The overall agreement between the tests was between 71-95%, whereas the specificity of all tests was within 98-100%. The correlation with patients' clinical symptoms score ranged from strongest in LIPS N (ρ = 0.41; p<0.001) to nonsignificant in LIPS S-RBD. Furthermore, the time of testing since symptom onset had an impact on the sensitivity of some tests. Our study highlights the importance to consider clinical symptoms, time of testing, and using more than one viral antigen in SARS-CoV-2 antibody testing. Our results suggest that some antibody tests are more sensitive for the detection of antibodies in early stage and asymptomatic patients, which may explain the contradictory results of previous studies and should be taken into consideration in clinical practice and epidemiological studies.

摘要

SARS-CoV-2 抗体检测有多种形式,可检测不同的病毒靶蛋白和抗体亚类。SARS-CoV-2 抗体检测的特异性和敏感性已知存在差异,且很少有研究针对不同时间点的 COVID-19 患者群体中这些检测的性能进行研究。我们在此比较了 97 例 COVID-19 患者和 100 例对照血清样本中 7 种商业(SNIBE、Epitope、Euroimmun、罗氏、雅培、DiaSorin、Biosensor)和 2 种内部 LIPS(LIPS N 和 LIPS S-RBD)IgG/总 Ab 检测的敏感性和特异性,并将结果与患者的临床数据和检测时间点相关联。我们发现,抗体检测的敏感性存在显著差异,具体性能如下:LIPS N(91.8%)、Epitope(85.6%)、雅培和内部 LIPS S-RBD(均为 84.5%)、罗氏(83.5%)、Euroimmun(82.5%)、DiaSorin(81.4%)、SNIBE(70.1%)和 Biosensor(64.9%)。各检测之间的总一致性在 71-95%之间,而所有检测的特异性均在 98-100%之间。与患者临床症状评分的相关性以 LIPS N 最强(ρ=0.41;p<0.001),到 LIPS S-RBD 则不显著。此外,自症状出现以来的检测时间对一些检测的敏感性有影响。我们的研究强调了在 SARS-CoV-2 抗体检测中考虑临床症状、检测时间和使用多种病毒抗原的重要性。我们的结果表明,一些抗体检测对于检测早期和无症状患者的抗体更敏感,这可能解释了先前研究结果的矛盾,并应在临床实践和流行病学研究中加以考虑。

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