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Evaluation of the performance of SARS-CoV-2 serological tools and their positioning in COVID-19 diagnostic strategies.
Diagnostic Microbiology and Infectious Disease ( IF 2.9 ) Pub Date : 2020-08-21 , DOI: 10.1016/j.diagmicrobio.2020.115181
Aurelie Velay 1 , Floriane Gallais 1 , Ilies Benotmane 1 , Marie Josée Wendling 2 , François Danion 3 , Olivier Collange 4 , Jérôme De Sèze 5 , Catherine Schmidt-Mutter 5 , Francis Schneider 6 , Pascal Bilbault 7 , Ferhat Meziani 8 , Samira Fafi-Kremer 1
Affiliation  

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 õenabling 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 reaction–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.



中文翻译:

评估SARS-CoV-2血清学工具的性能及其在COVID-19诊断策略中的位置。

快速准确的诊断对于成功控制疫情至关重要。在当前的冠状病毒疾病2019(COVID-19)公共卫生紧急情况下,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。其他诊断方法õ使能够检测当前或过去的SARS-CoV-2感染将非常有益。我们使用325个样品评估了2种免疫色谱法横向流动测定法(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):来自聚合酶链反应的血清样品确诊的COVID-19住院患者(n  = 55)和医护人员(n = 143)和阴性对照的127个样本。根据症状发作后的天数(dso)和制造商使用的抗原形式评估诊断性能。这些测定之间的临床敏感性差异很大,显示出相互之间的一致性差。15 dso后,结合IgM和IgG检测的ELISA-1(Euroimmun)和LFA-1(Biosynex)表现出最佳性能。建议彻底选择用于进行中或过去感染的血清学检测。

更新日期:2020-09-20
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