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"Lab Alert: Changes to CDC RT-PCR for SARS-CoV-2 Testing"

Also a nerd alert.

Tessa Lena
Jul 24, 2021
∙ Paid

This story is very technical, I just had to write it because the below announcement from the CDC raises interesting questions.

The CDC is changing their position on their own SARS-CoV-2 PCR test (“CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time Reverse Transcriptase (RT)-PCR Diagnostic Panel”)

In their own words,

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.

Visit the FDA website for a list of authorized COVID-19 diagnostic methods. For a summary of the performance of FDA-authorized molecular methods with an FDA reference panel, visit this page.

What diagnostic tests will be re…

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