March 23 Update – FAQs on Diagnostic Testing for SARS-CoV-2

March 23 Update: New Information on Diagnostic Testing for SARS-CoV-2

Thank you for your interest in development of diagnostics for SARS-CoV-2.  On March 23, 2020, the FDA updated the frequently asked questions on diagnostic testing to include the following information: If I do not have assay positive control materials, how can I obtain it? I am developing a SARS-CoV-2 test and would like to request genomic RNA from SARS-related coronavirus 2, Isolate USA-WA1/2020 to validate my test. How may I do that? I am having trouble obtaining viral transport media/universal transport media (VTM/UTM) and a flocked nasopharyngeal swab to collect and transport patient samples. Are there alternatives that I can use?

See updates to FAQs Questions? Email CDRH-EUA-Templates@fda.hhs.gov