The Centers for Disease Control and Prevention in the US, the American equivalent of Health Canada, has quietly stopped supporting the RT-PCR test. No reason is provided. They have set a December deadline to allow labs which do testing, to use up materials on hand and switch to some other method of testing that the FDA approves[4].
In a Laboratory Alert[1], the CDC states (emphasis added):
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.
CDC (2021)[1]
This says that the test may be used until December 31, 2021, but after that its use will have no FDA approval and therefore be illegal. The term “Diagnostic Panel” refers to the test kits that the CDC produces to send to labs as an “assay” or reference to calibrate their test equipment with{2][3].
The application of RT-PCR to SARS-CoV-2 was granted EUA in February 2020. This means that the development of the agents and reagents in the test panel presumably had to go back into January 2020 or late 2019 before COVOD-19 is generally recognized as existing.
The test has been a center of controversy from the beginning. Claims of false positives are generally recognized as being around 50% or more. It’s inventor, Kerry Mullis, in the following short video essentially says that it can’t be used to diagnose COVID-19 infection.
References
- 07/21/2021: Lab Alert: Changes to CDC RT-PCR for SARS-CoV-2 Testing. CDC. July 21, 2021.
- CDC Diagnostic Tests for COVID-19. CDC. Updated August 05, 2020.
- CDC’s Diagnostic Test for COVID-19 Only and Supplies. CDC. Updated July 13, 2021.
- In Vitro Diagnostics EUAs. FDAA. May 24, 2021.
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