新型冠状病毒血清学检测方法在 SARS-CoV-2 感染和 COVID-19 诊断中的研究进展。
Recent Advances in the Evaluation of Serological Assays for the Diagnosis of SARS-CoV-2 Infection and COVID-19.
机构信息
Microbiology Unit, Department of Specialized, Experimental, and Diagnostic Medicine, Istituto di Ricovero e Cura a Carattere Scientifico St. Orsola Polyclinic, University of Bologna, Bologna, Italy.
Department of Medical and Surgical Sciences, Istituto di Ricovero e Cura a Carattere Scientifico St. Orsola Polyclinic, University of Bologna, Bologna, Italy.
出版信息
Front Public Health. 2021 Feb 18;8:620222. doi: 10.3389/fpubh.2020.620222. eCollection 2020.
Few data on the diagnostic performance of serological tests for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection are currently available. We evaluated sensitivity and specificity of five different widely used commercial serological assays for the detection of SARS-CoV-2-specific IgG, IgM, and IgA antibodies using reverse transcriptase-PCR assay in nasopharyngeal swab as reference standard test. A total of 337 plasma samples collected in the period April-June 2020 from SARS-CoV-2 RT-PCR positive ( = 207) and negative ( = 130) subjects were investigated by one point-of-care lateral flow immunochromatographic assay (LFIA IgG and IgM, Technogenetics) and four fully automated assays: two chemiluminescence immunoassays (CLIA-iFlash IgG and IgM, Shenzhen YHLO Biotech and CLIA-LIAISON XL IgG, DiaSorin), one electrochemiluminescence immunoassay (ECLIA-Elecsys total predominant IgG, Roche), and one enzyme-linked immunosorbent assay (ELISA IgA, Euroimmune). The overall sensitivity of all IgG serological assays was >80% and the specificity was >97%. The sensitivity of IgG assays was lower within 2 weeks from the onset of symptoms ranging from 70.8 to 80%. The LFIA and CLIA-iFlash IgM showed an overall low sensitivity of 47.6 and 54.6%, while the specificity was 98.5 and 96.2%, respectively. The ELISA IgA yielded a sensitivity of 84.3% and specificity of 81.7%. However, the ELISA IgA result was indeterminate in 11.7% of cases. IgG serological assays seem to be a reliable tool for the retrospective diagnosis of SARS-CoV-2 infection. IgM assays seem to have a low sensitivity and IgA assay is limited by a substantial rate of indeterminate results.
目前关于严重急性呼吸综合征冠状病毒 2 (SARS-CoV-2) 感染血清学检测的诊断性能的数据较少。我们使用鼻咽拭子逆转录酶-聚合酶链反应 (RT-PCR) 检测作为参考标准试验,评估了五种广泛使用的商业血清学检测 IgG、IgM 和 IgA 抗体检测 SARS-CoV-2 特异性的敏感性和特异性。共检测了 2020 年 4 月至 6 月期间收集的 337 份 SARS-CoV-2 RT-PCR 阳性(=207)和阴性(=130)患者的血浆样本,使用一种即时侧向流动免疫层析检测(LFIA IgG 和 IgM,Technogenetics)和四种全自动检测:两种化学发光免疫分析(CLIA-iFlash IgG 和 IgM,深圳亚辉龙生物科技和 CLIA-LIAISON XL IgG,DiaSorin),一种电化学发光免疫分析(ECLIA-Elecsys 总主要 IgG,罗氏)和一种酶联免疫吸附试验(ELISA IgA,Euroimmune)。所有 IgG 血清学检测的总体敏感性均>80%,特异性均>97%。症状出现后 2 周内 IgG 检测的敏感性范围为 70.8%至 80%,相对较低。LFIA 和 CLIA-iFlash IgM 的总体敏感性较低,分别为 47.6%和 54.6%,特异性分别为 98.5%和 96.2%。ELISA IgA 的敏感性为 84.3%,特异性为 81.7%。然而,ELISA IgA 结果在 11.7%的情况下不确定。 IgG 血清学检测似乎是 SARS-CoV-2 感染回顾性诊断的可靠工具。IgM 检测的敏感性似乎较低,而 IgA 检测受到大量不确定结果的限制。