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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

Research output: Contribution to journalArticle

Andrew M Shaw, Christopher Hyde, Blair Merrick, Philip James-Pemberton, Bethany K Squires, Rouslan V Olkhov, Rahul Batra, Amita Patel, Karen Bisnauthsing, Gaia Nebbia, Eithne MacMahon, Sam Douthwaite, Michael Malim, Stuart Neil, Rocio Martinez Nunez, Katie Doores, Tan Kia Ik Mark, Adrian W Signell, Gilberto Betancor, Harry D Wilson & 3 more Rui Pedro Galão, Suzanne Pickering, Jonathan D Edgeworth

Original languageEnglish
Pages (from-to)5638-5646
Number of pages9
JournalAnalyst
Volume145
Issue number16
Early online date8 Jul 2020
DOIs
Publication statusPublished - 21 Aug 2020

King's Authors

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.

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