CDC Withdrawing Emergency Use Authorization of PCR Testing By Year’s End
As we previously reported, Covid-19 PCR tests are highly inaccurate. In fact, we learned that kids are faking positive results using soft drinks, so these tests aren’t exactly the gold standard for determining if you have the WuFlu.
Now comes the announcement that:
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.
In preparation for this change, CDC recommends clinical laboratories and testing sites that have been using the CDC 2019-nCoV RT-PCR assay select and begin their transition to another FDA-authorized COVID-19 test. CDC encourages laboratories to consider adoption of a multiplexed method that can facilitate detection and differentiation of SARS-CoV-2 and influenza viruses.
That statement shows that the CDC will stop using PCR tests to detect COVID-19 by the end of the year.
Dara Lo, Medical Devices Analyst at GlobalData, offered that, “This planned withdrawal could mark a bellwether of EUA approved COVID-19 tests coming to an end. This would have a huge impact on the entire COVID-19 testing industry in the U.S., which is currently comprised almost entirely of COVID-19 tests with only FDA EUA approval. In contrast to fully FDA approved medical tests, EUAs are only given during a declared emergency; outside of this, an EUA cannot be given and cannot be used. With the significant decline in COVID-19 testing in the US reported in the first half of the year, and the wide availability of COVID-19 vaccines, this state of emergency cannot last forever. Yet, COVID-19 testing will remain paramount in the monitoring of the prevalence of COVID-19, as well as vaccine efficacy. So even when the pandemic passes, COVID-19 tests will still be needed, similar to how influenza testing is regularly used. If and when FDA EUA comes to an end, manufacturers of COVID-19 tests will need to seek regular FDA approval, which can require even more clinical evidence than what was required for an EUA.”
The FDA has either revoked emergency use authorization (EUA) or stated to stop using many tests, including:
- Curative SARS-Cov-2 Test for COVID-19 (false negative results)
- Innova Medical Group SARS-CoV-2 Antigen Rapid Qualitative Test (false positive and false negative results)
- Lepu Medical Technology SARS-CoV-2 Antigen and Leccurate Antibody Tests (false positive and false negative results on both)
- BD SARS-CoV-2 Reagents for the BD Max System (false positive results)
- Quidel Lyra SARS-CoV-2 Assay (false negative results)
The complete listing is posted on the FDA website.
