Mar 20 Update – FAQs on Diagnostic Testing for SARS-CoV-2

https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-diagnostic-testing-sars-cov-2?utm_campaign=2020-03-20%20Mar%2020%20Update%3A%20New%20Information%20on%20Diagnostic%20Testing%20for%20SARS-CoV-2&utm_medium=email&utm_source=Eloqua

Mar 20 Update: New Information on Diagnostic Testing for SARS-CoV-2

Thank you for your interest in development of diagnostics for SARS-CoV-2.  The FDA has updated the frequently asked questions on diagnostic testing to include the following information: 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? What tests for COVID-19 have received Emergency Use Authorization? What laboratories are offering testing under the policy outlined in Section IV. A of the Policy for Diagnostic Tests for Coronavirus Disease-2019? What States or territories have chosen to authorize laboratories with that State or territory to develop and perform a test for COVID-19 under the policy outlined in Section IV.B of the Policy for Diagnostic Tests for Coronavirus Disease-2019? What commercial manufacturers are distributing test kits under the policy outlined in Section IV.C of the Policy for Diagnostic Tests for Coronavirus Disease-2019? What serology tests are being offered under the policy outlined in Section IV.D of the Policy for Diagnostic Tests for Coronavirus Disease-2019?

See Updates to FAQs

Questions? Email CDRH-EUA-Templates@fda.hhs.gov