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聽LFD聽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 鈥榢nown performance鈥�). These evaluations were conducted one after the other, with each new evaluation building on the results of the previous one.