Abstract
Robust assay development for SARS-CoV-2 serological testing requires assessment of asymptomatic and non-hospitalised individuals to determine if assays are sensitive to mild antibody responses. Our study evaluated the performance characteristics of two high-throughput SARS-CoV-2 IgG nucleocapsid assays (Abbott Architect and Roche) and The Binding Site (TBS) Anti-Spike IgG/A/M ELISA kit in samples from healthcare workers (HCWs). The 252 samples were collected from multi-site NHS trusts and analysed for SARS-CoV-2 serology. Assay performance was evaluated between these three platforms and ROC curves were used to redefine the Abbott threshold. Concordance between Abbott and TBS was 66%. Any discrepant results were analysed using Roche, which showed 100% concordance with TBS. Analysis conducted in HCWs within 58 days post-PCR result demonstrated 100% sensitivity for both Abbott and Roche. Longitudinal analysis for >100 days post-PCR led to sensitivity of 77.2% and 100% for Abbott and Roche, respectively. A redefined Abbott threshold (0.64) increased sensitivity to 90%, producing results comparable to TBS and Roche. The manufacturer’s threshold set by Abbott contributes to lower sensitivity and elevated false-negative occurrences. Abbott performance improved upon re-optimisation of the cut-off threshold. Our findings provided evidence that TBS can be used as bespoke alternative for SARS-CoV-2 serology analysis where high-throughput platforms are not feasible on site.
Highlights
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus responsible for coronavirus disease 2019 (COVID-19), has led to a global pandemic with more than 183 million confirmed infections and 3.9 million fatalities [1]
SARS-CoV-2 testing is represented by the initial detection of the virus in nasopharyngeal specimens by real-time polymerase chain reaction (RT-PCR), which is currently considered as the gold standard for confirming suspected diagnosis and identifying asymptomatic carriers [2]
The urgent need to better understand SARS-CoV-2 seroprevalence during the first wave of the pandemic led to regulatory bodies, such as the Food and Drug Administration (FDA) and the Medicines and Healthcare products Regulatory agency (MHRA), to approve the Abbott Architect nucleocapsid (NC) IgG assay [Abbott, Chicago, IL, USA] and Elecsys® Anti-SARS-CoV-2 IgG nucleocapsid immunoassays [Roche, Basel, Switzerland]
Summary
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus responsible for coronavirus disease 2019 (COVID-19), has led to a global pandemic with more than 183 million confirmed infections and 3.9 million fatalities [1]. SARS-CoV-2 testing is represented by the initial detection of the virus in nasopharyngeal specimens by real-time polymerase chain reaction (RT-PCR), which is currently considered as the gold standard for confirming suspected diagnosis and identifying asymptomatic carriers [2]. Complementing RT-PCR investigation is serological testing, which utilises immunoassays for the detection of SARS-CoV-2 antibodies as a measure of the adaptive immune response to natural infection and/or vaccines. Other uses of serological analysis include assessing the individual infection risk and measuring humoral immunity elicited in vaccine trials [4]
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