Validation testing to determine the sensitivity of lateral flow testing for asymptomatic SARSCoV-2 detection in low prevalence settings: Testing frequency and public health messaging is key

Jack Ferguson, Steven Dunn, Angus Best, Jeremy Mirza, Benita Percival, Megan Mayhew, Oliver Megram, Fiona Ashford, Thomas White, Emma Moles-Garcia, Liam Crawford, Tim Plant, Andrew Bosworth, Michael Kidd, Alex Richter, Jonathan Deeks, Alan McNally*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

44 Citations (Scopus)
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Abstract

Lateral flow devices (LFDs) are quickly being implemented for use in large-scale population surveillance programs for SARS-CoV-2 infection in the United Kingdom. These programs have been piloted in city-wide screening in the city of Liverpool and are now being rolled out to support care home visits and the return home of University students for the Christmas break. Here, we present data on the performance of LFDs to test almost 8,000 students at the University of Birmingham between December 2 and December 9, 2020. The performance is validated against almost 800 samples using PCR performed in the University Pillar 2 testing lab and theoretically validated on thousands of Pillar 2 PCR testing results performed on low-prevalence care home testing samples. Our data show that LFDs do not detect infections presenting with PCR Ct values over 29 to 30 as determined using the Thermo Fisher TaqPath asssay. This may be of particular importance in detecting individuals that are either at the early, or late stages of infection, and reinforces the need for frequent, recurrent testing.

Original languageEnglish
Article numbere3001216
JournalPLoS Biology
Volume19
Issue number4
DOIs
Publication statusPublished - 29 Apr 2021

Bibliographical note

Funding Information: The PCR testing in this manuscript is funded by the UK Department for Health and Social Care (DHSC) as part of pillar 2 testing, in an award made directly to the University of Birmingham. The provision of LFD tests is funded by DHSC as part of a national student testing program, and funded directly to the University of Birmingham. DHSC have had no role in in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Open Access: This is an open access article distributed under the terms of the
Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Publisher Copyright: © 2021 Ferguson et al.

Citation: Ferguson J, Dunn S, Best A, Mirza J, Percival B, Mayhew M, et al. (2021) Validation testing to determine the sensitivity of lateral flow testing for asymptomatic SARS-CoV-2 detection in low prevalence settings: Testing frequency and public health messaging is key. PLoS Biol 19(4): e3001216.

DOI: https://doi.org/10.1371/journal.pbio.3001216

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