The Food and Drug Administration (FDA) issued guidance (press release) to provide a policy for novel coronavirus (COVID-19) diagnostic tests developed and used in clinical laboratories under the Clinical Laboratory Improvements Amendments (CLIA). The policy allows certain laboratories to develop and use validated COVID-19 diagnostics before the FDA has completed the review of their Emergency Use Authorization (EUA) requests. The agency notes that this guidance will achieve more rapid testing capacity in the United States. The guidance is effective immediately.
The guidance applies to laboratories certified to perform high-complexity testing under CLIA, that comply with CLIA requirements, that have developed and are using their own validated diagnostic test, and are pursuing an EUA.
The guidance provides recommendations on the following:
- Test validation – The FDA provides recommendations regarding the minimum testing to be performed to ensure analytical and clinical validity of the test. Specifically, the agency suggests documenting the limit of detection, confirming the performance of the assay with a series of contrived clinical specimens, documenting the results of an in silico analysis, and using cross-reactivity testing.
- FDA notification – Once the test is validated, the FDA recommends that laboratories notify the agency via email at CDRH-EUA-Templates@fda.hhs.gov.
- Interim confirmatory clinical testing – While awaiting EUA request determination, the agency recommends that laboratories obtain confirmation of the first five positive and first five negative clinical specimens using an EUA-authorized assay.
The FDA will be hosting a webinar on the guidance today at 3:00 pm ET. Additional details can be found here.
In addition to the FDA guidance, the Centers for Disease Control and Prevention (CDC) issued updated guidance on evaluating and testing persons under investigation (PUI) for COVID-19. Specifically, the guidance recommends testing for health care personnel that have been in close contact (within six feet and for a prolonged period) of individuals suspected as having COVID-19.
Additional information can be found here for the CDC’s updated Interim Healthcare Infection Prevention and Control Recommendations for Patients with Confirmed COVD-19 or PUI for COVID-19.
The guidance also provides special considerations for personnel exposed in healthcare settings in the CDC’s Guidance for Risk Assessment and Public Health Management of Healthcare Personnel with Potential Exposure in a Healthcare Setting to Patients with COVID-19