Wednesday, December 2, 2020

December 2 Update - FAQs on Testing for SARS-CoV-2

FDA has updated Info on Testing for SARS-CoV-2

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US Food and Drug Administration

December 2 Update: Updated Information on 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 following questions:

Serology/Antibody Tests

  • If antibody tests are not used for diagnosis or exclusionof COVID-19 infection, what is their purpose?

COVID-19 Testing Supplies

  • I am considering offering clinical testing using the CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel. What are the considerations I should be aware of regarding extraction platforms ?

FAQs on Testing for SARS-CoV-2

Questions?

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


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