Evaluation of SARS-CoV-2 lateral flow device sensitivity: a comparison of systematic laboratory assessments with manufacturer-reported sensitivity.

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 healthc

SUBMITTER: Kulasegaran-Shylini R 

PROVIDER: S-EPMC12496196 | biostudies-literature | 2025 Sep

REPOSITORIES: biostudies-literature