The FDA issued a new policy that allows the use of validated COVID-19 diagnostics while the agency reviews Emergency Use Authorization (EUA) requests.
The agency also issued a final guidance that will allow the use of the tests for clinical testing while laboratories are pursuing an EUA. The new policy only applies to laboratories that are certified to perform high-complexity testing.
FDA Commissioner Stephen Hahn said the agency is not changing its standards for issuing EUAs, but it is “rapidly responding and adapting to this dynamic and evolving situation.”
CDRH Director Jeff Shuren said the agency is “dedicating all available resources to expediting the review of medical products, including diagnostics, to prevent the spread of the outbreak.
“For a reasonable period of time after validation” and while they are preparing their EAU requests, the FDA does not intend to object to the use of these tests for specimen testing, the guidance says, noting that 15 days is a reasonable timeframe to prepare an EUA submission for a test that has already been validated.
The tests will be performed in CLIA-certified high-complexity laboratories, and additional testing and confirmation procedures should be performed. The FDA expects that labs will need to design and manufacture individual test kit components or to purchase research-use-only components from third-party manufacturers to development the assays.
Clinical tests should be validated before use, and the guidance provides recommendations regarding minimum testing to ensure analytical and clinical validity of the tests. The agency said it also encourages labs to discuss alternative test methods.
The guidance recommends that labs document the limit of detection of their SARS-CoV-2 assay, and that they test a dilution series of three replicates per concentration and then confirm the final concentration with 20 replicates.
Once the assay is validated, labs should notify the FDA, and while awaiting the agency’s decision on the EUA request, the FDA recommends that labs get confirmation of the first five positive and the first five negative clinical specimens using an EUA-authorized assay.
Read the FDA guidance here: www.fdanews.com/03-04-20-FinalGuidance.pdf.