Clinical evaluation of commercial automated SARS-CoV-2 immunoassays
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 t...
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| Main Authors: | , , , , |
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| Format: | Article (Journal) |
| Language: | English |
| Published: |
February 2021
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| In: |
International journal of infectious diseases
Year: 2021, Volume: 103, Pages: 590-596 |
| ISSN: | 1878-3511 |
| DOI: | 10.1016/j.ijid.2020.12.003 |
| Online Access: | Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1016/j.ijid.2020.12.003 Verlag, lizenzpflichtig, Volltext: https://www.sciencedirect.com/science/article/pii/S1201971220325261 
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| Author Notes: | Maximilian Kittel, Maria Christina Muth, Ingrid Zahn, Heinz-Jürgen Roth, Margot Thiaucourt, Catharina Gerhards, Verena Haselmann, Michael Neumaier, Peter Findeisen |
| Summary: | 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. |
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| Item Description: | Gesehen am 31.03.2021 |
| Physical Description: | Online Resource |
| ISSN: | 1878-3511 |
| DOI: | 10.1016/j.ijid.2020.12.003 |