Lateral flow device (LFD) performance data
LFDs have proved vital for detecting SARS-CoV-2 when it is most infectious. This has remained true with new variants including Alpha, Delta and Omicron.
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Following the roll-out of rapid testing, the UK Health Security Agency (UKHSA) has published further analysis of rapid testing using lateral flow devices (LFDs).
The findings show the tests are more sensitive (how good the test is at detecting true positives) with higher viral loads (people most likely to be infectious).
The performance data includes studies submitted to the Medicines and Healthcare products Regulatory Agency (MHRA) as part of the exceptional use authorisation.
Routine post-market surveillance also shows there is no significant difference in the Innova LFDs’ ability to detect the Delta and Alpha variants.
Further evaluation of rapid testing with LFDs between November 2020 and March 2022 supports the earlier finding that the sensitivity of tests improves with higher viral loads, suggesting that LFDs are an effective test for infectious cases of coronavirus (COVID-19). All the different devices routinely used in the NTP met or exceeded the standards set when the MHRA granted the exceptional use authorisation (EUA).
We present here a full technical report with analyses, together with a short-form document summarising the key points.
Last updated 27 April 2023 + show all updates
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Added 'Analysis of real-world performance of lateral flow antigen devices in detecting SARS-CoV-2 Omicron variant (B.1.1.529)', 'Comparison of manufacturer reported lateral flow device sensitivity with the sensitivity observed in evaluation', and 'Testing for SARS-CoV-2 using antigen-detecting lateral flow devices'.
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Added 'Performance of lateral flow devices during the COVID-19 pandemic' and 'Evaluation of lateral flow device performance within the National Testing Programme' reports.
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First published.