Performance of the Abbott SARS-CoV-2 IgG II Quantitative antibody assay including the new Variants of Concern (VOC 202012/V1 (UK) and VOC 202012/V2 (South Africa)): And first steps towards global harmonization of COVID-19 antibody methods

English, Emma, Cook, Laura E., Piec, Isabelle, Dervisevic, Samir, Fraser, William D. and John, W. Garry (2021) Performance of the Abbott SARS-CoV-2 IgG II Quantitative antibody assay including the new Variants of Concern (VOC 202012/V1 (UK) and VOC 202012/V2 (South Africa)): And first steps towards global harmonization of COVID-19 antibody methods. Journal of Clinical Microbiology. ISSN 0095-1137

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Abstract

Background: In the initial stages of the SARS-CoV-2 (COVID-19) pandemic a plethora of new serology tests were developed and introduced to the global market. Many were not evaluated rigorously and there is a significant lack of concordance in results across methods. To enable meaningful clinical decisions to be made, robustly evaluated, quantitative serology methods are needed. These should be harmonized to a primary reference material, allowing for the comparison of trial data and improved clinical decision making. Methods: A comprehensive evaluation of the new Abbott IgG II anti-SARS-CoV-2 IgG method was undertaken using CLSI based protocols. Two different candidate primary reference materials and verification panels were assessed with a goal to moving towards harmonization. Results: The Abbott IgG II method performs well across a wide range of parameters with excellent imprecision (<3.5%) and is linear throughout the positive range (tested to 38,365 AU/mL). The sensitivity (based on ≥14 day post positive RT-PCR samples) and specificity are 98.3% [90.6-100.0%] and 99.5% [97.1-100%] respectively. The candidate reference materials showed poor correlation across methods with mixed responses noted in methods that use the spike protein versus the nucleocapsid proteins as their binding antigen. Conclusions: The Abbott IgG II anti-SARS-CoV-2 measurement appears to be the first linear method potentially capable of monitoring the immune response to natural infection, including from new emerging variants. The candidate reference materials assessed do not generate uniform results across several methods and further steps are needed to enable the harmonization process.

Item Type: Article
Faculty \ School: Faculty of Medicine and Health Sciences > School of Health Sciences
Faculty of Medicine and Health Sciences > Norwich Medical School
Depositing User: LivePure Connector
Date Deposited: 21 Jul 2021 01:49
Last Modified: 21 Jul 2021 01:49
URI: https://ueaeprints.uea.ac.uk/id/eprint/80650
DOI: 10.1128/JCM.00288-21

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