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Early data on the performance of a combined SARS-CoV-2 spike-nucleocapsid antibody lateral flow immunoassay device compared with a nucleocapsid-only device.

Introduction There is a critical need for reliable antibody detection methods in order to study and evaluate the public health and clinical response to the ongoing coronavirus disease 2019 (COVID-19) pandemic.1 Lateral flow immunoassay (LFIA) devices potentially offer the prospect of rapid point-of-care testing (POCT), but the performance of these devices must be evaluated for robustness before they can be adopted for routine clinical and public health use.2-4 Furthermore, as of when this study was conducted in May 2020, there were no published studies of these LFIA devices for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibodies. Materials and methods In the present study, anonymised, residual stored plasma and serum specimens from SARS-CoV-2 RNA-positive (n=131) and presumed (pre-COVID-19) or RNA-negative (n=37) patients were taken from various time points with respect to the onset of symptoms. Applying a 21-day cut-off for the Abbexa device revealed performance that was very close to meeting the minimum sensitivity and specificity thresholds (98%) set by the UK Medicines and Healthcare Products Regulatory Agency (MHRA).5 The Abbexa device captures antibodies against both SARS-CoV-2 spike and nucleocapsid proteins, as opposed to Hangzhou, which targets only the nucleocapsid protein.2,6-8 We therefore propose that spike glycoprotein antibodies be considered as an additional moiety to test as part of the standard diagnostic approach towards SARS-CoV-2 antibody profiling9-10 to improve clinical sensitivity and potentially specificity, pending follow-up studies to confirm this approach. * Conflicts of interest None declared.