FAQs on Diagnostic Testing for SARS-CoV-2 | FDA

FAQs on Diagnostic Testing for SARS-CoV-2 | FDA

April 22 Update: New Information on Diagnostic 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 question: 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? If I do not have assay positive control material, how can I obtain it? If I do not have human extraction control material, how can I obtain it? Added the following frequently asked question and answer: I am developing a SARS-CoV-2 test.  What test materials are appropriate for assay validation?

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