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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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Title: Point-of-care SARS-CoV-2 serological assays for enhanced case finding in a UK inpatient population.
Authors: Pallett, SJC
Denny, S
Patel, A
Charani, E
Mughal, N
Stebbing, J
Davies, G
Moore, L
Item Type: Journal Article
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.
Issue Date: 12-Mar-2021
Date of Acceptance: 23-Feb-2021
URI: http://hdl.handle.net/10044/1/86230
DOI: 10.1038/s41598-021-85247-w
ISSN: 2045-2322
Publisher: Nature Publishing Group
Start Page: 1
End Page: 8
Journal / Book Title: Scientific Reports
Volume: 11
Issue: 5860
Copyright Statement: © The Author(s) 2021. This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.
Sponsor/Funder: National Institute for Health Research
Imperial College Healthcare NHS Trust- BRC Funding
Funder's Grant Number: NIHR-RP-011-053
RDB01 79560
Publication Status: Published
Online Publication Date: 2021-03-12
Appears in Collections:Department of Surgery and Cancer
Department of Infectious Diseases
Faculty of Medicine
Imperial College London COVID-19



This item is licensed under a Creative Commons License Creative Commons