Chapter 2 – Emergency Use Authorization of a Diagnostic Test for COVID-19
Many of us want to understand what our governments are doing in response to the public health emergency presented by COVID-19. As part of the US response, on February 4th the FDA authorized the emergency use of a diagnostic test developed by the Centers for Disease Control and Prevention (CDC). The test uses real time RT-PCR to amplify nucleic acid fragments associated with COVID-19 and return a fluorescent signal when the virus is detected. It’s a complex test, and only labs that are designated as qualified by the CDC will have access to the materials needed to perform it. Read more about the test specifics in the manufacturer instructions. The fact sheets for patients and providers are also interesting sources.
Reach out to me if you want to know more or discuss your medical product development challenges.
Text Copyright © 2020 Katrina Rogers
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