Evaluation of LFD performance against Delta and Omicron variants of concern
Two evaluations commissioned to determine LFD performance when Delta and Omicron variants of SARS-CoV-2 were declared variants of concern (VOC) in the UK.
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Lateral flow device (LFD) evaluations were commissioned when Delta and Omicron variants of SARS-CoV-2 were declared variants of concern (VOC) in the UK.
The first report provides a summary of findings from laboratory-based assessments and routine clinical post-market surveillance conducted between 1 April and 2 June 2021 with a specific focus on evaluating the performance of the Biotime LFD test in detecting the Delta (B.1.617.2) and Alpha (B.1.1.7) variants.
The second report covers 4 evaluations (referred to as eval 1, eval 2, eval 3 and eval 4), where data from health electronic records (HER) was used to monitor the performance and diagnostic accuracy of LFDs to detect the Omicron variant, which emerged as a variant of concern. The objective of these evaluations was to determine whether these LFDs could detect Omicron as effectively as they could detect earlier variants (the ‘known performance’). These evaluations were conducted one after the other, with each new evaluation building on the results of the previous one.