The U.S. Food and Drug Administration (FDA) has updated its set of frequently asked questions (FAQs) that serve as guidelines for clinical labs that are performing diagnostic tests for SARS-CoV-2, the novel coronavirus that causes the COVID-19 respiratory disease.
The agency's FAQ page explains in more detail the policy the FDA announced on February 29, when it said it would allow labs to use their own tests for SARS-CoV-2 without first receiving emergency use authorization (EUA) from the agency.
The FAQs include the following questions:
- What happens if I do not have the extraction platform referenced in the authorization of the U.S. Centers for Disease Control and Prevention's (CDC) EUA-authorized test?
- Are two or more viral targets needed to validate a reverse transcription polymerase chain reaction (RT-PCR) SARS-CoV-2 assay?
- I am offering my own test under the new policy outlined in the Policy for Diagnostics Testing for Coronavirus Disease-2019. Do I report all my results as presumptive?
- If I do not have assay-positive control material, how can I obtain it?
The FAQs also include a list of labs that are performing coronavirus tests under the February 29 guidance. Many other labs are providing coronavirus tests using an emergency use authorization, the FDA noted. The FAQs are available on the agency's website.