Clinical performances of three fully automated anti-SARS-CoV-2 immunoassays targeting the nucleocapsid or spike proteins
Clinical performances of three fully automated anti-SARS-CoV-2 immunoassays targeting the nucleocapsid or spike proteins
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DOI：
10.1002/jmv.26669
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发表时间：
2020-12-01
影响因子：
12.7
通讯作者：
Douxfils, Jonathan
中科院分区：
文献类型：
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作者：
Favresse, Julien;Cadrobbi, Julie;Douxfils, Jonathan
本研究评估了三种抗 SARS-CoV-2 检测的临床性能，即 EUROIMMUN 抗 SARS-CoV-2 核衣壳 (IgG) ELISA、Elecsys 抗 SARS-CoV-2 核衣壳（总抗体）检测以及 LIAISON 抗 SARS-CoV-2 刺突蛋白 S1 和 S2 (IgG) 检测。选择来自 96 名逆转录聚合酶链反应确诊患者的 137 份 2019 冠状病毒病 (COVID-19) 样本进行敏感性分析。特异性分析中纳入了与 SARS-CoV-2 免疫测定存在潜在交叉反应的非 SARS-CoV-2 血清 (n = 141)。这些测试均未表现出足够高的临床敏感性来诊断急性感染。症状出现十四天后，我们没有发现三种技术在敏感性方面有任何显着差异。然而，Elecsys 在特异性方面表现更好。所有三种抗 SARS-CoV-2 检测在症状出现后 14 天诊断过去的 COVID-19 感染方面具有相同的灵敏度。我们还证实，在第 14 天之前进行抗 SARS-CoV-2 测定的临床意义较小。
This study assesses the clinical performance of three anti-SARS-CoV-2 assays, namely EUROIMMUN anti-SARS-CoV-2 nucleocapsid (IgG) ELISA, Elecsys anti-SARS-CoV-2 nucleocapsid (total antibodies) assay, and LIAISON anti-SARS-CoV-2 spike proteins S1 and S2 (IgG) assay. One hundred and thirty-seven coronavirus disease 2019 (COVID-19) samples from 96 reverse-transcription polymerase chain reaction confirmed patients were chosen to perform the sensitivity analysis. Non-SARS-CoV-2 sera (n = 141) with a potential cross-reaction to SARS-CoV-2 immunoassays were included in the specificity analysis. None of these tests demonstrated a sufficiently high clinical sensitivity to diagnose acute infection. Fourteen days since symptom onset, we did not find any significant difference between the three techniques in terms of sensitivities. However, Elecsys performed better in terms of specificity. All three anti-SARS-CoV-2 assays had equivalent sensitivities 14 days from symptom onset to diagnose past-COVID-19 infection. We also confirmed that anti-SARS-CoV-2 determination before Day 14 is of less clinical interest.