Evaluation of SARS-CoV-2 lateral flow device sensitivity: a comparison of systematic laboratory assessments with manufacturer-reported sensitivity.
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All Authors
Kulasegaran-Shylini, R.
Bown, A.
Collinge, T.
Sienkiewicz, A.
Eyre, DW.
Crook, D.
Walker, AS.
Bell, J.
Williamson, DA.
Oliver, I.
LTHT Author
Wilcox, Mark
LTHT Department
Pathology
Microbiology
Microbiology
Non Medic
Publication Date
2025
Item Type
Journal Article
Language
Subject
Subject Headings
Abstract
Background: Self-testing for SARS-CoV-2 infection using lateral flow devices (LFDs) was a key component of the COVID-19 pandemic response; however, LFD performance has shown a high degree of variability. Between August 2020 and July 2023, the UK Health Security Agency (UKHSA), including predecessor organisations, undertook a three-phase SARS-CoV-2 test development and evaluation programme to independently evaluate commercially available SARS-CoV-2 LFDs, incorporating standardised laboratory assessment of test sensitivity. Here we describe results from a comparison of UKHSA laboratory assessment findings with manufacturer-reported LFD sensitivity data.
Methods: The UKHSA assessed the sensitivity of LFDs, by laboratory testing of surplus clinical samples from a secondary healthcare setting. These data were compared with manufacturer-reported clinical sensitivity data and analytical sensitivity (limit of detection [LOD; 50% tissue culture infectious dose [TCID50]/mL]) from LFD instructions for use (IFU).
Findings: UKHSA-determined LFD sensitivity ranged from 32 to 83%. Of 86 LFDs assessed, 73 included device sensitivity data in the manufacturers' IFU that claimed clinical sensitivity >=85%, and 49 claimed clinical sensitivity >=95%. No evidence of correlation was observed between manufacturer-reported test sensitivity and UKHSA determined test sensitivity, and no evidence of correlation was observed between manufacturer-reported test LOD and UKHSA-determined test sensitivity.
Interpretation: Laboratory evaluation found no evidence of correlation between manufacturer-reported SARS-CoV-2 LFD sensitivity data and UKHSA laboratory-determined sensitivity, supporting previous reports of discrepancies. Our findings suggest that manufacturer-reported performance data and claims for SARS-CoV-2 LFDs should be interpreted with caution and support the need for independent monitoring and testing, and standardisation of analysis methodologies.
Funding: This study was funded by UK Department of Health and Social Care; UK Health Security Agency (formerly Public Health England and the National Health Service Test and Trace); and the University of Oxford NIHR Biomedical Research Centre. Crown
Journal
EClinicalMedicine