Performance and validation of an adaptable multiplex assay for detection of serologic response to SARS-CoV-2 infection or vaccination

Grace Kenny; Riya Negi; Sophie O'Reilly; Alejandro Garcia-Leon; Dana Alalwan; Colette Marie Gaillard; Gurvin Saini; Rosana Inzitari; Eoin R Feeney; Obada Yousif; Aoife G Cotter; Eoghan de Barra; Corinna Sadlier; Fiona Crispie; Peter Doran; Virginie Gautier; Patrick W G Mallon; All Ireland Infectious Diseases cohort study

doi:10.1016/j.jim.2022.113345

Performance and validation of an adaptable multiplex assay for detection of serologic response to SARS-CoV-2 infection or vaccination

J Immunol Methods. 2022 Nov:510:113345. doi: 10.1016/j.jim.2022.113345. Epub 2022 Aug 30.

Authors

Grace Kenny¹, Riya Negi², Sophie O'Reilly², Alejandro Garcia-Leon², Dana Alalwan², Colette Marie Gaillard², Gurvin Saini², Rosana Inzitari³, Eoin R Feeney⁴, Obada Yousif⁵, Aoife G Cotter⁶, Eoghan de Barra⁷, Corinna Sadlier⁸, Fiona Crispie⁹, Peter Doran³, Virginie Gautier², Patrick W G Mallon⁴; All Ireland Infectious Diseases cohort study

Affiliations

¹ Centre for Experimental Pathogen Host Research (CEPHR), University College Dublin, Belfield, Dublin 4, Ireland; Department of Infectious Diseases, St Vincent's University Hospital, Elm Park, Dublin 4, Ireland. Electronic address: grace.kenny1@ucd.ie.
² Centre for Experimental Pathogen Host Research (CEPHR), University College Dublin, Belfield, Dublin 4, Ireland.
³ School of Medicine, University College Dublin, Belfield, Dublin 4, Ireland.
⁴ Centre for Experimental Pathogen Host Research (CEPHR), University College Dublin, Belfield, Dublin 4, Ireland; Department of Infectious Diseases, St Vincent's University Hospital, Elm Park, Dublin 4, Ireland.
⁵ Endocrinology Department, Wexford General Hospital, Carricklawn, Wexford, Ireland.
⁶ Centre for Experimental Pathogen Host Research (CEPHR), University College Dublin, Belfield, Dublin 4, Ireland; Department of Infectious Diseases, Mater Misericordiae University Hospital, Eccles St, Dublin 7, Ireland.
⁷ Department of Infectious Diseases, Beaumont Hospital, Beaumont, Dublin 9, Ireland; Department of International Health and Tropical Medicine, Royal College of Surgeons in Ireland, Dublin, Ireland.
⁸ Department of Infectious Diseases, Cork University Hospital, Wilton, Co Cork, Ireland.
⁹ Teagasc Food Research Centre, Moorepark, Ireland; APC Microbiome Ireland, Cork, Ireland.

Abstract

Measurement of quantitative antibody responses are increasingly important in evaluating the immune response to infection and vaccination. In this study we describe the validation of a quantitative, multiplex serologic assay utilising an electrochemiluminescence platform, which measures IgG against the receptor binding domain (RBD), spike S1 and S2 subunits and nucleocapsid antigens of SARS-CoV-2. The assay displayed a sensitivity ranging from 73 to 91% and specificity from 90 to 96% in detecting previous infection with SARS-CoV-2 depending on antigenic target and time since infection, and this assay highly correlated with commercially available assays. The within-plate coefficient of variation ranged from 3.8-3.9% and the inter-plate coefficient of variation from 11 to 13% for each antigen.

Keywords: COVID-19; SARS-CoV-2; Serology.

Publication types

Research Support, U.S. Gov't, Non-P.H.S.
Research Support, Non-U.S. Gov't

MeSH terms

Antibodies, Viral
COVID-19 Testing
COVID-19* / diagnosis
Humans
Immunoglobulin G
SARS-CoV-2
Sensitivity and Specificity
Spike Glycoprotein, Coronavirus
Vaccination

Substances

Antibodies, Viral
Immunoglobulin G
Spike Glycoprotein, Coronavirus
spike protein, SARS-CoV-2