Outcome of the evaluation of rapid diagnostic assays for specific SARS-CoV-2 antigens (lateral flow devices)
Since its establishment in August 2020, the joint UK Health Security Agency (UKHSA) Porton Down and University of Oxford SARS-CoV-2 lateral flow antigen test validation cell has evaluated over 160 lateral flow devices that have been referred by the Department of Health and Social Care.
Approximately 30% of the tests that were referred for validation met the standards for phase 2 validation, which are set out in the protocol for evaluation of rapid diagnostic assays for specific SARS-CoV-2 antigens.
UKHSA Porton Down subsequently performed phase 3 testing to assess whether the lateral flow devices that passed phase 2 displayed performance characteristics desirable for mass population, community-based testing.
The desirable performance characteristics are:
- very high specificity
- very high sensitivity against viral loads associated with infectiousness
The lateral flow devices that display the desirable performance characteristics are summarised in table 1 below.
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