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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
Authors: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
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.

Antigen-detecting lateral flow tests are faster than PCR tests in detecting SARS-CoV-2 infection and are being implemented for use in large-scale population surveillance in the UK. An evaluation of the performance of the lateral flow devices, validated using PCR, concludes that lateral flow devices do not detect infections presenting with higher PCR Ct values, reinforcing the need for frequent, recurrent testing.
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