Evaluation of the performance of SARS-CoV-2 serological tools and their positioning in COVID-19 diagnostic strategies
Evaluation of the performance of SARS-CoV-2 serological tools and their positioning in COVID-19 diagnostic strategies
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DOI：
10.1016/j.diagmicrobio.2020.115181
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发表时间：
2020-12-01
影响因子：
2.9
通讯作者：
Fafi-Kremer, Samira
中科院分区：
文献类型：
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作者：
Velay, Aurelie;Gallais, Floriane;Fafi-Kremer, Samira
快速、准确的诊断对于成功遏制疫情至关重要。在当前2019冠状病毒病（COVID-19）突发公共卫生事件期间，严重急性呼吸综合征冠状病毒2（SARS-CoV-2）感染诊断的金标准是检测病毒RNA。能够检测当前或过去的 SARS-CoV-2 感染的其他诊断方法将非常有益。我们使用 325 个样本评估了 2 种免疫层析侧向层析测定（LFA-1、LFA-2）和 2 种酶联免疫吸附测定试剂盒（IgA/IgG ELISA-1、IgM/IgG ELISA-2）：来自聚合酶链反应确诊的 COVID-19 住院患者 (n = 55) 和医护人员 (n = 143) 的血清样本以及来自阴性对照的 127 个样本。根据症状出现后的天数 (dso) 和制造商使用的抗原形式评估诊断性能。不同检测方法的临床敏感性差异很大，相互一致性较差。 15 dso 后，结合 IgM 和 IgG 检测的 ELISA-1 (Euroimmun) 和 LFA-1 (Biosynex) 显示出最佳性能。建议全面选择血清学检测来检测当前或过去的感染。 (c) 2020 Elsevier Inc. 保留所有权利。
Rapid and accurate diagnosis is crucial for successful outbreak containment. During the current coronavirus disease 2019 (COVID-19) public health emergency, the gold standard for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection diagnosis is the detection of viral RNA. Additional diagnostic methods oenabling the detection of current or past SARS-CoV-2 infection would be highly beneficial. We assessed 2 immunochromatographic lateral flow assays (LFA-1, LFA-2) and 2 enzyme-linked immunosorbent assay kits (IgA/IgG ELISA-1, IgM/IgG ELISA-2) using 325 samples: serum samples from polymerase chain reac-tion-confirmed COVID-19 hospitalized patients (n = 55) and healthcare workers (n = 143) and 127 samples from negative controls. Diagnostic performances were assessed according to days after symptom onset (dso) and the antigenic format used by manufacturers. Clinical sensitivities varied greatly among the assays, showing poor mutual agreement. After 15 dso, ELISA-1 (Euroimmun) and LFA-1 (Biosynex) combining IgM and IgG detection showed the best performances. A thorough selection of serological assays for the detection of ongoing or past infections is advisable. (c) 2020 Elsevier Inc. All rights reserved.