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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.
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.
  • Cook AM; The Binding Site Group Ltd, 8 Calthorpe Road, Birmingham B15 1QT, UK.
  • Faustini SE; Clinical Immunology Service, University of Birmingham College of Medical and Dental Sciences, Birmingham B15 2TT, UK.
  • Williams LJ; The Binding Site Group Ltd, 8 Calthorpe Road, Birmingham B15 1QT, UK. Electronic address: Leigh.Williams@bindingsite.com.
  • Cunningham AF; Institute of Immunology and Immunotherapy, University of Birmingham, Birmingham B15 2TT, UK.
  • Drayson MT; Clinical Immunology Service, University of Birmingham College of Medical and Dental Sciences, Birmingham B15 2TT, UK.
  • Shields AM; Clinical Immunology Service, University of Birmingham College of Medical and Dental Sciences, Birmingham B15 2TT, UK; University Hospitals Birmingham, NHS Foundation Trust, Birmingham B15 2GW, UK.
  • Kay D; The Binding Site Group Ltd, 8 Calthorpe Road, Birmingham B15 1QT, UK.
  • Taylor L; The Royal Wolverhampton NHS Trust, Wolverhampton Road, Wolverhampton, West Midlands WV10 0QP, UK.
  • Plant T; Clinical Immunology Service, University of Birmingham College of Medical and Dental Sciences, Birmingham B15 2TT, UK.
  • Huissoon A; Institute of Immunology and Immunotherapy, University of Birmingham, Birmingham B15 2TT, UK; University Hospitals Birmingham, NHS Foundation Trust, Birmingham B15 2GW, UK.
  • Wallis G; The Binding Site Group Ltd, 8 Calthorpe Road, Birmingham B15 1QT, UK.
  • Beck S; University Hospitals Birmingham, NHS Foundation Trust, Birmingham B15 2GW, UK.
  • Jossi SE; Institute of Immunology and Immunotherapy, University of Birmingham, Birmingham B15 2TT, UK.
  • Perez-Toledo M; Institute of Immunology and Immunotherapy, University of Birmingham, Birmingham B15 2TT, UK.
  • Newby ML; School of Biological Sciences, University of Southampton, Southampton SO17 1BJ, UK.
  • Allen JD; School of Biological Sciences, University of Southampton, Southampton SO17 1BJ, UK.
  • Crispin M; School of Biological Sciences, University of Southampton, Southampton SO17 1BJ, UK.
  • Harding S; The Binding Site Group Ltd, 8 Calthorpe Road, Birmingham B15 1QT, UK.
  • Richter AG; Clinical Immunology Service, University of Birmingham College of Medical and Dental Sciences, Birmingham B15 2TT, UK; University Hospitals Birmingham, NHS Foundation Trust, Birmingham B15 2GW, UK.
J Immunol Methods ; 494: 113046, 2021 07.
Article in English | MEDLINE | ID: covidwho-1155530
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 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.

RESULTS:

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%).

CONCLUSIONS:

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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Serological Testing / SARS-CoV-2 / COVID-19 / Antibodies, Viral Type of study: Diagnostic study / Prognostic study / Randomized controlled trials Limits: Adult / Female / Humans / Male / Middle aged Language: English Journal: J Immunol Methods Year: 2021 Document Type: Article Affiliation country: J.jim.2021.113046

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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Serological Testing / SARS-CoV-2 / COVID-19 / Antibodies, Viral Type of study: Diagnostic study / Prognostic study / Randomized controlled trials Limits: Adult / Female / Humans / Male / Middle aged Language: English Journal: J Immunol Methods Year: 2021 Document Type: Article Affiliation country: J.jim.2021.113046