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评估严重急性呼吸综合征冠状病毒2（SARS-CoV-2）血清学检测工具的性能及其在2019冠状病毒病（COVID-19）诊断策略中的定位。

Evaluation of the performance of SARS-CoV-2 serological tools and their positioning in COVID-19 diagnostic strategies.

作者信息

Velay Aurelie, Gallais Floriane, Benotmane Ilies, Wendling Marie Josée, Danion François, Collange Olivier, De Sèze Jérôme, Schmidt-Mutter Catherine, Schneider Francis, Bilbault Pascal, Meziani Ferhat, Fafi-Kremer Samira

机构信息

Laboratoire de Virologie, Hôpitaux Universitaires de Strasbourg, Strasbourg, France; INSERM, UMR_S1109, LabEx TRANSPLANTEX, Centre de Recherche d'Immunologie et d'Hématologie, Faculté de Médecine, Fédération Hospitalo-Universitaire (FHU) OMICARE, Fédération de Médecine Translationnelle de Strasbourg (FMTS), Université de Strasbourg, Strasbourg, France.

Laboratoire de Virologie, Hôpitaux Universitaires de Strasbourg, Strasbourg, France.

出版信息

Diagn Microbiol Infect Dis. 2020 Dec;98(4):115181. doi: 10.1016/j.diagmicrobio.2020.115181. Epub 2020 Aug 21.

DOI:10.1016/j.diagmicrobio.2020.115181
PMID:32957073
原文链接:
https://pmc.ncbi.nlm.nih.gov/articles/PMC7441068/
Abstract

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.

摘要

快速准确的诊断对于成功控制疫情至关重要。在当前的2019冠状病毒病（COVID-19）公共卫生紧急事件期间，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。能够检测当前或既往SARS-CoV-2感染的其他诊断方法将非常有益。我们使用325份样本评估了2种免疫层析侧向流动分析法（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）：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127份阴性对照样本。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。各检测方法的临床敏感性差异很大，相互之间一致性较差。在症状出现15天后，联合检测IgM和IgG的ELISA-1（欧蒙）和LFA-1（百欧森）表现最佳。建议对检测正在进行或既往感染的血清学检测方法进行全面筛选。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5b48/7441068/1f00dc518bb1/gr4_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5b48/7441068/634a101fcddc/gr1_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5b48/7441068/ffcdc2a0e1d2/gr2_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5b48/7441068/418cc321d12e/gr3_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5b48/7441068/1f00dc518bb1/gr4_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5b48/7441068/634a101fcddc/gr1_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5b48/7441068/ffcdc2a0e1d2/gr2_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5b48/7441068/418cc321d12e/gr3_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5b48/7441068/1f00dc518bb1/gr4_lrg.jpg

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