The US FDA Grants Emergency Use Authorization for Coronavirus Diagnostic Test

The US FDA Grants Emergency Use Authorization for Coronavirus Diagnostic Test

Shots:

  • 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