Recent Advances in the Evaluation of Serological Assays for the Diagnosis of SARS-CoV-2 Infection and COVID-19

Frontiers in Public Health

article

Angela Chiereghin¹  Matteo Pavoni¹  Silvia Lafratta¹  Alessandro Deni¹  Silvia Felici¹  Michele Borghi¹  Luca Guerra²  Luigi Raumer²  Vittorio Lodi³  Pierluigi Viale⁴  Luciano Attard⁴  Rocco Maurizio Zagari⁴  Tiziana Lazzarotto¹  Silvia Galli⁵  Alessandra Moroni⁵  Liliana Gabrielli⁵  Simona Venturoli⁵  Isabella Bon⁵  Giada Rossini⁵  Ilaria Maria Saracino¹ 

[1] Microbiology Unit, Department of Specialized, and Diagnostic Medicine, Istituto di Ricovero e Cura a Carattere Scientifico St. Orsola Polyclinic, University of Bologna;Infectious Diseases Unit, Department of Medical and Surgical Sciences, Istituto di Ricovero e Cura a Carattere Scientifico St. Orsola Polyclinic and Azienda Unita' Sanitaria Locale Bologna;Occupational Health Unit, Istituto di Ricovero e Cura a Carattere Scientifico St. Orsola Polyclinic, University of Bologna;Infectious Diseases Unit, Department of Medical and Surgical Sciences, Istituto di Ricovero e Cura a Carattere Scientifico St. Orsola Polyclinic, University of Bologna;Microbiology Unit, Istituto di Ricovero e Cura a Carattere Scientifico St. Orsola Polyclinic, University of Bologna

关键词: SARS-CoV-2 infection;    COVID-19;    SARS-CoV-2 RT-PCR;    SARS-CoV-2-specific antibodies;    LFIA;    CLIA;    ECLIA and ELISA;    sensitivity and specificity;   

DOI  :  10.3389/fpubh.2020.620222

学科分类：社会科学、人文和艺术（综合）

来源: Frontiers

【 摘 要 】

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.

【 授权许可】

CC BY