The FDA has allowed so called RT-PCR testing under the pretense that it’s effective for virus detection. It has been given emergency use authorization, which is set to run out in December 2021. Okay, what will take its place, or will this whole hoax come to an end?
“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.”
Public health officials in Canada always talk about how they are “following the science”. Turns out, at least part of it has been farmed out to the United States. And what is adopted here is sketchy, at best. If Canada is relying on this “testing” method, and the U.S. stops, what happens here?
Read between the lines on Health Canada’s own website.
Health Canada says in its own guidelines that it uses the USFDA as a reference point in how nucleic-acid based tests are conducted. That’s quite interesting considering that the FDA’s own tests are not approved, but instead have emergency use authorization. And that is set to lapse at the end of 2021. And it’s about to get more interesting from that.
Now, FDA approval is different than FDA emergency use authorization. This parallels Health Canada, in which approval is different than interim authorization. The FDA lists a few circumstances where EUA will be given. The following is from their site:
Presumably, the emergency use authorization is granted under #3. However, the document makes it clear that this is not the same thing as being approved. Furthermore, when the emergency is over, sales and distributions of such products must end.
Health Canada links that FDA document on their own site. Presumably, this is used as a starting point for how the Canadian Government handles such things.
Under Section B on that same page, Health Canada lists the “specific nucleic acid sequences from the genome of the SARS-CoV-2 (please specify the targeted gene(s) of the pathogen).” In other words, these tests are not supposed to test for an isolated virus, but to test for a gene, or a portion of a virus — assuming it exists.
Health Canada, again, same page, asks companies applying for an authorization to disclose the known limitations of their testing equipment. On F, Proposed Intended Use, it provides the following:
- Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history and epidemiological information.
- Negative results from pooled samples should be treated as presumptive. If inconsistent with clinical signs and symptoms or necessary for patient management, pooled samples should be tested individually. Negative results do not preclude SARS-CoV-2 infection and must not be used as the sole basis for patient management decisions. Negative results must be considered in the context of a patient’s recent exposures, history, presence of clinical signs and symptoms consistent with COVID-19.
- Use of the [test name] in a general, asymptomatic screening population is intended to be used as part of an infection control plan, that may include additional preventative measures, such as a predefined serial testing plan or directed testing of high-risk individuals. Negative results should be considered presumptive and do not preclude current or future infection obtained through community transmission or other exposures. Negative results must be considered in the context of an individual’s recent exposures, history, presence of clinical signs and symptoms consistent with COVID-19.
These are what Health Canada lists as examples (emphasis mine). In other words, the tests, if negative, don’t really mean negative. It must be taken in context of other factors. This is a long way away from being the “gold standard” that we are always told it is.
Such guidelines seem ripe for abuse, as a test result could mean whatever the person wants it to be. The above disclaimer means that it’s very subjective, and unreliable as a standardized medical or scientific device.
The BC Centre for Disease Control admitted in April 2020 that the tests are useless. If they can’t detect infection, and the actual error rate is unknown, then they are of no help, other than to artificially drive up false positives. Also, let’s not forget this now scrubbed article of Bonnie Henry admitting false positives could overburden the hospitals. Does this virus even exist?
Other provinces, like Ontario and Manitoba, claim that PCR tests are the “gold standard”. At testing what exactly?
It’s not just nucleic acid tests (or PCR tests) that are held to virtually non-existent standards. Other tests follow the same pattern.
Under Section F: Proposed intended use, there are some rather lengthy disclaimers to be added in. In short, these tests are to be used as an emergency authorized test by the FDA, not approved.
Beyond that, the test results are meaningless. A positive result could be a false positive, and a negative result could be a false positive. It’s only to be used in conjunction with a patient’s history. Again, this is competely subjective.
Interim Orders, like this one signed on March 30, 2020, allow medical devices and medications to be distributed in Canada, even if they don’t meet all the regulatory conditions. In short, as long as there is an “emergency”, there will always be a way to get them into the market.
That Order since lapsed, and Patty Hajdu signed another one on March 1, 2021. Theoretically, as long as this keeps getting extended, then Health Canada will never need to make a determination as to whether these products are safe.
The above listings are limitations of serology testing. All of these tests come with a common disclaimer: we don’t know that they actually work.
If people haven’t figured out by now that this is all a scam, then they probably never will. This is obvious to anyone paying attention.
(15) FDA Emergency Use Guidelines