sábado, 21 de marzo de 2020

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?

Questions?

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