RE: Key para11 Nov 2020 16:18
The LFD that is currently in most advanced stages of validation is the Innova SARS-CoV-2 Antigen Rapid Qualitative Test, which reflects the fact that it was one of the first tests to be evaluated and successfully pass Phase 2.
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Analyses of LFDs are at an advanced stage of evaluation in the United Kingdom. A comprehensive, systematic national pipeline has been established to rapidly evaluate the performance characteristics of LFD in laboratory and a multitude of community settings (hospitals, military establishments, schools, universities and COVID-19 testing centres). Many of the LFDs tested to date have not performed to levels established by the test and validation cell and confirmed by the LFD Oversight Group to proceed to community field service evaluations. However, a small number of LFDs have the desired performance characteristics and phase 4 evaluations have been completed for the Innova SARS-CoV-2 Antigen rapid qualitative test.