Real-world evaluation of a novel technology for quantitative simultaneous antibody detection against multiple SARS-CoV-2 antigens in a cohort of patients presenting with COVID-19 syndrome
Shaw, A; Hyde, C; Merrick, B; et al.James-Pemberton, P; Squires, B; Olkhov, R; Batra, R; Patel, A; Bisnauthsing, K; Nebbia, G; Macmahon, E; Douthwaite, S; Malim, M; Neil, S; Rocio Martinez, R; Doores, K; Kia Ik Mark, T; Signell, A; Betancor, G; Wilson, H; Pedro Galao, R; Pickering, S; Edgeworth, J
Date: 8 July 2020
Journal
Analyst
Publisher
Royal Society of Chemistry
Publisher DOI
Abstract
An evaluation of a rapid portable gold-nanotechnology measuring SARS-CoV-2 IgM, IgA and IgG antibody concentrations against spike 1 (S1), spike 2 (S) and nucleocapsid (N) was conducted using serum
samples from 74 patients tested for SARS-CoV-2 RNA on admission to hospital, and 47 historical control
patients from March 2019. 59 patients ...
An evaluation of a rapid portable gold-nanotechnology measuring SARS-CoV-2 IgM, IgA and IgG antibody concentrations against spike 1 (S1), spike 2 (S) and nucleocapsid (N) was conducted using serum
samples from 74 patients tested for SARS-CoV-2 RNA on admission to hospital, and 47 historical control
patients from March 2019. 59 patients were RNA(+) and 15 were RNA(−). A serum (±) classification was
derived for all three antigens and a quantitative serological profile was obtained. Serum(+) was identified
in 30% (95% CI 11–48) of initially RNA(−) patients, in 36% (95% CI 17–54) of RNA(+) patients before 10
days, 77% (95% CI 67–87) between 10 and 20 days and 95% (95% CI 86–100) after 21 days. The patientlevel diagnostic accuracy relative to RNA(±) after 10 days displayed 88% sensitivity (95% CI 75–95) and
75% specificity (95% CI 22–99), although specificity compared with historical controls was 100% (95%CI
91–100). This study provides robust support for further evaluation and validation of this novel technology
in a clinical setting and highlights challenges inherent in assessment of serological tests for an emerging
disease such as COVID-19.
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