A highly sensitive and specific SARS-CoV-2 spike- and nucleoprotein-based fluorescent multiplex immunoassay (FMIA) to measure IgG, IgA and IgM class antibodies
| Autor: | Merit Melin, Camilla Virta, Nina Ekström, Johanna Lempainen, Laura Kakkola, Timothee Dub, Anna Solastie, Ilkka Julkunen, Pinja Jalkanen, Simo Miettinen, Anu Kantele, Anu Haveri |
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| Rok vydání: | 2021 |
| Předmět: |
chemistry.chemical_classification
0303 health sciences medicine.diagnostic_test biology business.industry Fluorescence Virology 3. Good health Serology Nucleoprotein 03 medical and health sciences Titer 0302 clinical medicine chemistry Immunoassay medicine biology.protein Multiplex 030212 general & internal medicine Antibody business Glycoprotein 030304 developmental biology |
| DOI: | 10.1101/2021.07.28.21260990 |
| Popis: | BackgroundValidation and standardization of accurate serological assays are crucial for the surveillance of the coronavirus disease 2019 (COVID-19) pandemic and population immunity.MethodsWe describe the analytical and clinical performance of an in-house fluorescent multiplex immunoassay (FMIA) for simultaneous quantification of antibodies against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleoprotein and spike glycoprotein. Furthermore, we calibrated IgG-FMIA against World Health Organisation (WHO) International Standard and compared FMIA results to an in-house enzyme immunoassay (EIA) and a microneutralisation test (MNT). We also compared the MNT results of two laboratories.ResultsIgG-FMIA displayed 100% specificity and sensitivity for samples collected 13-150 days post-onset of symptoms (DPO). For IgA- and IgM-FMIA 100% specificity and sensitivity were obtained for a shorter time window (13-36 and 13-28 DPO for IgA- and IgM-FMIA, respectively). FMIA and EIA results displayed moderate to strong correlation, but FMIA was overall more specific and sensitive. IgG-FMIA identified 100% of samples with neutralising antibodies (NAbs). Anti-spike IgG concentrations correlated strongly (ρ=0.77-0.84, P−16) with NAb titers. The NAb titers of the two laboratories displayed a very strong correlation (ρ=0.95, P−16).DiscussionOur results indicate good correlation and concordance of antibody concentrations measured with different types of in-house SARS-CoV-2 antibody assays. Calibration against WHO international standard did not, however, improve the comparability of FMIA and EIA results. |
| Databáze: | OpenAIRE |
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