The CDC originally applied for EUA status for the RT-PCR test for COVID-19 in February 2020. Since then, it has proved to be notoriously unreliable and has largely been discredited as a diagnostic tool to detect the COVID-19 virus. The test will be outlawed on January 1, 2022.
However, when reading the details on the CDC website, a strong smell of rotting fish fills the room.
First, the test was never granted full FDA approval. Instead, it was permitted for use under the Emergency Use Authorization (EUA). In other words, it was an experimental diagnostic tool.
And yet, it was used to drive the entire nation into the Great Panic that literally turned our society upside down.
Second, the Lab Alert directs clinicians to “Visit the FDA website for a list of authorized COVID-19 diagnostic methods.”
According to the FDA’s own rules, no EUA can be granted for an experimental drug/treatment if an approved solution already exists. Furthermore, if an EUA is in play for one drug and another drug is approved for the same application, then the EUA on the experimental drug is immediately removed.
So, the CDC is pulling the experimental RT-PCE test while telling clinicians to find “authorized COVID-19 diagnostic methods” instead.
You don’t need to be a PhD, MD or epidemiologist with a peer-reviewed study to figure this out. In fact, you don’t need any medical expertise whatsoever.
An unapproved experimental testing diagnostic was used to trick people into taking unapproved experimental mRNA injections.
Alas, the infamous snake oil salesmen of the 1800s did not go extinct with the rise of modern science. Instead, the trickery just became more subtle.
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. Such assays can facilitate continued testing for both influenza and SARS-CoV-2 and can save both time and resources as we head into influenza season. Laboratories and testing sites should validate and verify their selected assay within their facility before beginning clinical testing.
- FAQ: CDC Distribution of COVID-19 Assays
- Guidance for SARS-CoV-2 Point-of-Care Testing
- Interim Guidance for SARS-CoV-2 Antigen Testing
- Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens for COVID-19
- Frequently Asked Questions about COVID-19 for Laboratories
- Information for Laboratories about COVID-19
- CDC COVID-19 Website
- Clinical Laboratory COVID-19 Response Weekly Calls
- CDC Laboratory Outreach Communication System (LOCS)
If you have any questions, please contact us at LOCS@cdc.gov.