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首页> 外文期刊>Frontiers in Public Health >Recent Advances in the Evaluation of Serological Assays for the Diagnosis of SARS-CoV-2 Infection and COVID-19
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Recent Advances in the Evaluation of Serological Assays for the Diagnosis of SARS-CoV-2 Infection and COVID-19

机译：SARS-COV-2感染和Covid-19诊断血清学检测评估的最新进展

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Introduction: 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. Methods: A total of 337 plasma samples collected in the period April–June 2020 from SARS-CoV-2 RT-PCR positive ( n = 207) and negative ( n = 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). Results: 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. Conclusions: 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.
机译：简介：目前可获得关于严重急性呼吸综合征冠状病毒2（SARS-COV-2）感染的血清学试验诊断性能的少数数据。我们评估了五种不同广泛使用的商业血清学测定的敏感性和特异性，用于检测SARS-COV-2特异性IgG，IgM和IgA抗体，在鼻咽拭子中使用逆转录酶-PCR测定作为参考标准试验。方法：通过一个护理点横向流动研究了从SARS-COV-2 RT-PCR阳性（n = 207）和阴性（n = 130）受试者中收集的337个血浆样本。免疫色谱法测定（LFIA IgG和IgM，TechnogeSetics）和四种全自动测定：两个化学发光免疫测定（Clia-Iflash IgG和IgM，深圳Yhlo Biotech和Clia-Liaison？XL IgG，DiaSorin），一种电化学发光免疫测定（Eclia-Elecsys？总优势IgG，罗氏）和一种酶联免疫吸附试验（Elisa Iga，EuroImmune）。结果：所有IgG血清学检测的总敏感性为80％，特异性为97％。从70.8至80％的症状开始，IgG测定的敏感性较低。 LFIA和CLIA-IFLASH IGM显示出47.6和54.6％的总体低灵敏度，分别为98.5和96.2％。 ELISA IgA产生84.3％的敏感性，特异性为81.7％。然而，ELISA IGA结果在11.7％的病例中不确定。结论：IgG血清学检测似乎是用于回顾性的SARS-COV-2感染的可靠工具。 IgM测定似乎具有低灵敏度，IgA测定受到实质性的不确定结果的限制。

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