2021
DOI: 10.1016/j.jim.2021.113046
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Validation of a combined ELISA to detect IgG, IgA and IgM antibody responses to SARS-CoV-2 in mild or moderate non-hospitalised patients

Abstract: Background 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. Methods Targeting the SARS-CoV-2 trimeric spike, a combined anti-IgG, IgA and IgM serology ELISA assay … Show more

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Cited by 47 publications
(49 citation statements)
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“…17,18 This assay has been CE-marked with 98.3% (95% CI 96.4-99.4) specificity and 98.6% (92.6-100.0) sensitivity following RT-PCR-confirmed mild-to-moderate COVID-19 that did not result in hospitalisation. 15 A cut-off ratio relative to the TBS cut-off calibrators was determined by plotting 624 pre-2019 negatives in a frequency histogram. A cut-off coefficient was then established for IgGAM (1.31), with ratio values classed as positive (≥1) or negative (<1).…”
Section: Methodsmentioning
confidence: 99%
“…17,18 This assay has been CE-marked with 98.3% (95% CI 96.4-99.4) specificity and 98.6% (92.6-100.0) sensitivity following RT-PCR-confirmed mild-to-moderate COVID-19 that did not result in hospitalisation. 15 A cut-off ratio relative to the TBS cut-off calibrators was determined by plotting 624 pre-2019 negatives in a frequency histogram. A cut-off coefficient was then established for IgGAM (1.31), with ratio values classed as positive (≥1) or negative (<1).…”
Section: Methodsmentioning
confidence: 99%
“…Sensitivity was 96.3% (92.1–98.6) and specificity 99.3% (98.4–99.8). The ELISA output result was reported as a ratio relative to the cutoff calibrator and multiplied by the previously determined cutoff co-efficient to maintain batch-to-batch consistency, defined as 1.31 ( Cook et al, 2020 ).…”
Section: Methodsmentioning
confidence: 99%
“… 7 9 The S protein is the major surface transmembrane protein and is the principle antigenic target in current vaccine strategies, 10 , 11 and a key component of serological tests. 12 , 13 It is therefore important that we understand the immunogenic surface of the S protein.…”
mentioning
confidence: 99%