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?
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