FAQs on Testing for SARS-CoV-2 | FDA

FAQs on Testing for SARS-CoV-2 | FDA

September 9 Update: New Information on Testing for SARS-CoV-2

Thank you for your interest in the development of diagnostics for SARS-CoV-2. 

The FDA recently:

UPDATED the answer to the following question:

• Can I request an EUA for my multi-analyte respiratory panel that includes SARS-CoV-2?
• I am considering offering clinical testing using the CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel. What are the considerations I should be aware of regarding extraction platforms?
• What if I do not have the instruments referenced in the authorization of the CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel?

ADDED the following question and answer:

• Can I leverage validation data that has already been reviewed by the FDA for another test?

See Update to FAQs

Questions?

Email CDRH-EUA-Templates@fda.hhs.gov