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The US FDA Grants Emergency Use Authorization for Coronavirus Diagnostic Test

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The US FDA Grants Emergency Use Authorization for Coronavirus Diagnostic Test

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  • The US FDA has granted EUA for state public health laboratories to initiate testing of coronavirus utilizing kits developed by the Centers for Disease Control and Prevention (CDC)
  • Under EUA- testing is limited to CDC’s qualified labs. The FDA issued EUA in collaboration with CDC and the Centers for Medicare and Medicaid Services- to prioritize the development and implementation of critical medical products in response to emerging infectious disease outbreaks
  • The diagnostic test is a reverse transcriptase PCR test providing presumptive detection of 2019-nCoV from respiratory secretions- such as nasal or oral swabs. A positive test result suggests patients to work with their HCPs to manage their symptoms and for better protection of people around them

Click here ­to­ read full press release/ article | Ref: US FDA | Image: NCB News


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