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

检测 SARS-CoV-2 感染或疫苗接种血清学反应的适应性多重检测法的执行和验证

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作者: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

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.

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