Point-of-care SARS-CoV-2 serological assays for enhanced case finding in a UK inpatient population

Abstract Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2) has become a global pandemic. Case identification is currently made by real-time polymerase chain reaction (PCR) during the acute phase and largely restricted to healthcare laboratories. Serological assays are emerging but indepen...

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Autores principales:	S. J. C. Pallett, S. J. Denny, A. Patel, E. Charani, N. Mughal, J. Stebbing, G. W. Davies, L. S. P. Moore
Formato:	article
Lenguaje:	EN
Publicado:	Nature Portfolio 2021
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/18645fb8647b4c11a3c7678cd9e26f8d
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spelling	oai:doaj.org-article:18645fb8647b4c11a3c7678cd9e26f8d2021-12-02T13:30:36ZPoint-of-care SARS-CoV-2 serological assays for enhanced case finding in a UK inpatient population10.1038/s41598-021-85247-w2045-2322https://doaj.org/article/18645fb8647b4c11a3c7678cd9e26f8d2021-03-01T00:00:00Zhttps://doi.org/10.1038/s41598-021-85247-whttps://doaj.org/toc/2045-2322Abstract Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2) has become a global pandemic. Case identification is currently made by real-time polymerase chain reaction (PCR) during the acute phase and largely restricted to healthcare laboratories. Serological assays are emerging but independent validation is urgently required to assess their utility. We evaluated five different point-of-care (POC) SARS-CoV-2 antibody test kits against PCR, finding concordance across the assays (n = 15). We subsequently tested 200 patients using the OrientGene COVID-19 IgG/IgM Rapid Test Cassette and find a sensitivity of 74% in the early infection period (day 5–9 post symptom onset), with 100% sensitivity not seen until day 13, demonstrating inferiority to PCR testing in the infectious period. Negative rate was 96%, but in validating the serological tests uncovered potential false-negatives from PCR testing late-presenting cases. A positive predictive value (PPV) of 37% in the general population precludes any use for general screening. Where a case definition is applied however, the PPV is substantially improved (95.4%), supporting use of serology testing in carefully targeted, high-risk populations. Larger studies in specific patient cohorts, including those with mild infection are urgently required to inform on the applicability of POC serological assays to help control the spread of SARS-CoV-2 and improve case finding of patients that may experience late complications.S. J. C. PallettS. J. DennyA. PatelE. CharaniN. MughalJ. StebbingG. W. DaviesL. S. P. MooreNature PortfolioarticleMedicineRScienceQENScientific Reports, Vol 11, Iss 1, Pp 1-8 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q S. J. C. Pallett S. J. Denny A. Patel E. Charani N. Mughal J. Stebbing G. W. Davies L. S. P. Moore Point-of-care SARS-CoV-2 serological assays for enhanced case finding in a UK inpatient population
description	Abstract Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2) has become a global pandemic. Case identification is currently made by real-time polymerase chain reaction (PCR) during the acute phase and largely restricted to healthcare laboratories. Serological assays are emerging but independent validation is urgently required to assess their utility. We evaluated five different point-of-care (POC) SARS-CoV-2 antibody test kits against PCR, finding concordance across the assays (n = 15). We subsequently tested 200 patients using the OrientGene COVID-19 IgG/IgM Rapid Test Cassette and find a sensitivity of 74% in the early infection period (day 5–9 post symptom onset), with 100% sensitivity not seen until day 13, demonstrating inferiority to PCR testing in the infectious period. Negative rate was 96%, but in validating the serological tests uncovered potential false-negatives from PCR testing late-presenting cases. A positive predictive value (PPV) of 37% in the general population precludes any use for general screening. Where a case definition is applied however, the PPV is substantially improved (95.4%), supporting use of serology testing in carefully targeted, high-risk populations. Larger studies in specific patient cohorts, including those with mild infection are urgently required to inform on the applicability of POC serological assays to help control the spread of SARS-CoV-2 and improve case finding of patients that may experience late complications.
format	article
author	S. J. C. Pallett S. J. Denny A. Patel E. Charani N. Mughal J. Stebbing G. W. Davies L. S. P. Moore
author_facet	S. J. C. Pallett S. J. Denny A. Patel E. Charani N. Mughal J. Stebbing G. W. Davies L. S. P. Moore
author_sort	S. J. C. Pallett
title	Point-of-care SARS-CoV-2 serological assays for enhanced case finding in a UK inpatient population
title_short	Point-of-care SARS-CoV-2 serological assays for enhanced case finding in a UK inpatient population
title_full	Point-of-care SARS-CoV-2 serological assays for enhanced case finding in a UK inpatient population
title_fullStr	Point-of-care SARS-CoV-2 serological assays for enhanced case finding in a UK inpatient population
title_full_unstemmed	Point-of-care SARS-CoV-2 serological assays for enhanced case finding in a UK inpatient population
title_sort	point-of-care sars-cov-2 serological assays for enhanced case finding in a uk inpatient population
publisher	Nature Portfolio
publishDate	2021
url	https://doaj.org/article/18645fb8647b4c11a3c7678cd9e26f8d
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Point-of-care SARS-CoV-2 serological assays for enhanced case finding in a UK inpatient population

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