CDC Lab Alert 07/21/21: 2019-Novel Coronavirus Real-Time RT-PCR Diagnostic Panel

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Updated December 20, 2021

On December 13, 2021, Yudi Sherman in the article, “CDC withdraws support for PCR tests” writes:

“The Centers for Disease Control and Prevention (CDC) will no longer recognize PCR tests as valid methods of diagnosing COVID-19 by the end of this year. The CDC announced in a lab alert on its website that it will be withdrawing its standing request to the Food and Drug Administration (FDA) to grant emergency use authorization for PCR tests to be used to detect SARS-CoV-2. The request, which was issued in February 2020, will be withdrawn on December 31, 2021, a move which signals that the CDC no longer approves of the use of PCR tests as valid diagnostic methods for COVID-19″.

In the CDC’s 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.”

The article states, “the false positive rate for PCR tests is reported to be at least 5%” meaning in countries like with widespread testing such as the UK, with a million people being tested each day approximately 50,000 are identified as Covid positive. A positive Covid test opens them to severe requirements such as isolation and quarantine without being infected. In a police state, such as Australia even more severe measures are instituted and include quarantine in interment camps.

ACCESS THE FULL Article from Aflds here

On Dec 31, 2021, the CDC will request revocation by the FDA for Emergency Use Authorization (EUA) the CDC 2019-Novel Coronavirus Real-Time RT-PCR Diagnostic Panel for the purpose of advance notification to clinical laboratories to have adequate time to identify select and put into place an FDA-authorized alternatives.

The test was introduced in February 2020 under EUA for detection of SARS-CoV-2 only.

Read Lab Alert Here
Access CDC 2019-Novel Coronavirus Real-Time RT-PCR Diagnostic Panel catalog Instructions for Use Updated July 21, 2021
ACCESS FDA FULL Removal Lists of Tests That Should No Longer Be Used and/or Distributed for COVID-19: FAQs on Testing for SARS-CoV-2

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