Clinical evaluation of commercial automated SARS-CoV-2 immunoassays

Autor: Maximilian Kittel, Maria Christina Muth, Ingrid Zahn, Heinz-Jürgen Roth, Margot Thiaucourt, Catharina Gerhards, Verena Haselmann, Michael Neumaier, Peter Findeisen
Jazyk: angličtina
Rok vydání: 2021
Předmět:
Zdroj: International Journal of Infectious Diseases, Vol 103, Iss , Pp 590-596 (2021)
Druh dokumentu: article
ISSN: 1201-9712
49124749
DOI: 10.1016/j.ijid.2020.12.003
Popis: Objective: Numerous immunoassays for detecting antibodies directed against SARS-CoV-2 have been rapidly developed and released. Validations of these have been performed with a limited number of samples. The lack of standardisation might lead to significantly different results. This study compared ten automated assays from six vendors in terms of sensitivity, specificity and reproducibility. Methods: This study compared ten fully automated immunoassays from the following vendors: Diasorin, Epitope Diagnostics, Euroimmun, Roche, YHLO, and Snibe. The retrospective part of the study included patients with a laboratory-confirmed COVID-19 infection, and controls comprised patients with a suspected infection, in whom the disease was excluded. Furthermore, biobanked sera were taken as negative controls (n = 97). The retrospective part involved four groups: (1) laboratory-confirmed COVID-19 infection (n = 183); (1B) suspected COVID-19 infection (n = 167) without a qRT-PCR result but positive serological results from at least two different assays, and suspected COVID-19 infection due to a positive serological result from the Roche assay (n = 295); (2) biobanked sera obtained from patients before the emergence of SARS-CoV-2 (n = 97) as negative controls; and (2A) probably COVID-19-negative sera with negative serological results from at least two different assays (n = 152). Results: Overall diagnostic sensitivities were: Euroimmun (IgA) 87%; Epitope Diagnostics (IgG) 83%; YHLO (IgG) 77%; Roche (IgM/IgG) 77%; Euroimmun (IgG) 75%; Diasorin (IgG) 53%; Epitope Diagnostics (IgM) 52%; Snibe (IgG) 47%; YHLO (IgM) 35%; and Snibe (IgM) 26%. Diagnostic specificities were: YHLO (IgG) 100%; Roche, 100%; Snibe (IgM/IgG) 100%; Diasorin (IgG) 97%; Euroimmun (IgG) 94%; YHLO (IgM) 94%; Euroimmun (IgA) 83%. Conclusion: Assays from different vendors substantially varied in terms of their performance. These findings might facilitate selection of appropriate serological assays.
Databáze: Directory of Open Access Journals
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