Validation of a combined ELISA to detect IgG, IgA and IgM antibody responses to SARS-CoV-2 in mild or moderate non-hospitalised patients

Frequently SARS-CoV-2 results in mild or moderate disease with potentially lower concentrations of antibodies compared to those that are hospitalised. Here, we validated an ELISA using SARS-CoV-2 trimeric spike glycoprotein, with targeted detection of IgG, IgA and IgM (IgGAM) using serum and dried b...

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Bibliographic Details
Published in:	Journal of immunological methods Vol. 494; p. 113046
Main Authors:	Cook, A.M., Faustini, S.E., Williams, L.J., Cunningham, A.F., Drayson, M.T., Shields, A.M., Kay, D., Taylor, L., Plant, T., Huissoon, A., Wallis, G., Beck, S., Jossi, S.E., Perez-Toledo, M., Newby, M.L., Allen, J.D., Crispin, M., Harding, S., Richter, A.G.
Format:	Journal Article
Language:	English
Published:	Netherlands Elsevier B.V 01-07-2021 Published by Elsevier B.V
Subjects:	Adult Antibodies, Viral - blood COVID-19 COVID-19 - blood COVID-19 - diagnosis COVID-19 Serological Testing Dried blood spot Enzyme-Linked Immunosorbent Assay Female Humans Immunoglobulin A - blood Immunoglobulin G - blood Immunoglobulin M - blood Low prevalence Male Middle Aged Mild disease Research Paper SARS-CoV-2 - metabolism Serological Trimeric spike protein COVID-19 Mild disease Trimeric spike protein Serological Dried blood spot Low prevalence
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Summary:	Frequently SARS-CoV-2 results in mild or moderate disease with potentially lower concentrations of antibodies compared to those that are hospitalised. Here, we validated an ELISA using SARS-CoV-2 trimeric spike glycoprotein, with targeted detection of IgG, IgA and IgM (IgGAM) using serum and dried blood spots (DBS) from adults with mild or moderate disease. Targeting the SARS-CoV-2 trimeric spike, a combined anti-IgG, IgA and IgM serology ELISA assay was developed using 62 PCR-confirmed non-hospitalised, mild or moderate COVID-19 samples, ≥14 days post symptom onset and 624 COVID-19 negative samples. The assay was validated using 73 PCR-confirmed non-hospitalised, mild or moderate COVID-19 samples, ≥14 days post symptom onset and 359 COVID-19 negative serum samples with an additional 81 DBSs. The assay was further validated in 226 PCR-confirmed non-hospitalised, mild or moderate COVID-19 samples, ≥14 days post symptom onset and 426 COVID-19 negative clinical samples. A sensitivity and specificity of 98.6% (95% CI, 92.6–100.0), 98.3% (95% CI, 96.4–99.4), respectively, was observed following validation of the SARS-CoV-2 ELISA. No cross-reactivities with endemic coronaviruses or other human viruses were observed, and no change in results were recorded for interfering substances. The assay was stable at temperature extremes and components were stable for 15 days once opened. A matrix comparison showed DBS to correlate with serum results. Clinical validation of the assay reported a sensitivity of 94.7% (95% CI, 90.9–97.2%) and a specificity of 98.4% (95% CI, 96.6–99.3%). The human anti-IgGAM SARS-CoV-2 ELISA provides accurate and sensitive detection of SARS-CoV-2 antibodies in non-hospitalised adults with mild or moderate disease. The use of dried blood spots makes the assay accessible to the wider community.
Bibliography:	ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Feature-1 content type line 23 ObjectType-Undefined-3
ISSN:	0022-1759 1872-7905 1872-7905
DOI:	10.1016/j.jim.2021.113046