Issue 16, 2020

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

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 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 patient-level 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.

Graphical abstract: 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

Supplementary files

Article information

Article type
Paper
Submitted
27 5 2020
Accepted
29 6 2020
First published
07 7 2020
This article is Open Access
Creative Commons BY license

Analyst, 2020,145, 5638-5646

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

A. M. Shaw, C. Hyde, B. Merrick, P. James-Pemberton, B. K. Squires, R. V. Olkhov, R. Batra, A. Patel, K. Bisnauthsing, G. Nebbia, E. MacMahon, S. Douthwaite, M. Malim, S. Neil, R. Martinez Nunez, K. Doores, T. K. I. Mark, A. W. Signell, G. Betancor, H. D. Wilson, R. P. Galão, S. Pickering and J. D. Edgeworth, Analyst, 2020, 145, 5638 DOI: 10.1039/D0AN01066A

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