UK Government Approval
“Since its establishment in August 2020, the joint PHE Porton Down and University of Oxford SARS-CoV-2 lateral flow antigen test validation cell has evaluated over 140 lateral flow devices that have been referred to the Department of Health and Social Care. PHE Porton Down subsequently performed phase 3 testing to assess whether the lateral flow devices that passed phase 2 display 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”
Healgen has been approved and can be found on the list of ‘Lateral flow devices that have passed phase 3a validation’ here.