CDC Revokes Emergency Use Authorisation To RT-PCR For COVID-19 Testing

The CDC has announced that they will revoke the emergency use authorization given to RT-PCR for COVID-19 testing.

On 21st July, 2021 the CDC gave out a Laboratory Alert revoking the EUA for RT-PCR tests to detect SARS-COV-2.

"After December 31, 2021, CDC will withdraw the request to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of the CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel, the assay first introduced in February 2020 for detection of SARS-CoV-2 only.

CDC is providing this advance notice for clinical laboratories to have adequate time to select and implement one of the many FDA-authorized alternatives."

The CDC also recommended clinical laboratories and testing sites using RT-PCR to transition to another FDA-authorized COVID-19 test.

"In preparation for this change, CDC recommends clinical laboratories and testing sites that have been u...

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