Recent Advances in the Evaluation of Serological Assays for the Diagnosis of SARS-CoV-2 Infection and COVID-19.
In: Frontiers in public health, Jg. 8 (2021-02-18), S. 620222
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Zugriff:
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.
Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
(Copyright © 2021 Chiereghin, Zagari, Galli, Moroni, Gabrielli, Venturoli, Bon, Rossini, Saracino, Pavoni, Lafratta, Deni, Felici, Borghi, Guerra, Raumer, Lodi, Viale, Attard, Lazzarotto and IRCCS St. Orsola Polyclinic of Bologna COVID-19 Research Team.)
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Recent Advances in the Evaluation of Serological Assays for the Diagnosis of SARS-CoV-2 Infection and COVID-19.
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Autor/in / Beteiligte Person: | Chiereghin, A ; Zagari, RM ; Galli, S ; Moroni, A ; Gabrielli, L ; Venturoli, S ; Bon, I ; Rossini, G ; Saracino, IM ; Pavoni, M ; Lafratta, S ; Deni, A ; Felici, S ; Borghi, M ; Guerra, L ; Raumer, L ; Lodi, V ; Viale, P ; Attard, L ; Lazzarotto, T |
Zeitschrift: | Frontiers in public health, Jg. 8 (2021-02-18), S. 620222 |
Veröffentlichung: | Lausanne : Frontiers Editorial Office, 2021 |
Medientyp: | academicJournal |
ISSN: | 2296-2565 (electronic) |
DOI: | 10.3389/fpubh.2020.620222 |
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