THE LITTLE SECRET ABOUT THE PCR TEST THAT CDC FORGOT TO HIDE

THE JOURNEY TO BETTER SCIENTIFIC INTEGRITY

You may have recently seen the bit going around about the PCR Test Diagnostic Panel admitting the that the “Isolates are not available” in the test template. Yep, its right there plain as day but that's not even the fun part!

Sometime in January of 2020, the CDC was discussing and applied to the FDA for an Emergency Use Authorization (EUA) for PCR testing. There were documents dated as late as January 31, 2020.  EUA was finally approved on February 4, 2020.

Also on February 4, 2020, the EUA for the PCR Diagnostic was published. This document is the template of the PCR test, in which all approved 3rd party test builds would have to baseline from.

Inside we find that now infamous paragraph.

Notice the wording of the original February 4, 2020, document. “Since no quantified virus isolates of the 2019-nCoV are currently available”. Except for one little problem. There is another document where the CDC states that they in fact did have them…lots of them!

The CDC reveals in its publication “SARS-CoV-2 Viral Culturing at CDC” that on January 20, 2020, they received their first samples of COVID-19 that came from an infected person to work with. Then they grew a whole bunch of it. The entire world’s supply of it to be precise.

So yes, in actual reality, they had plenty COVID-19 virus isolates to work with.

PUTTING THIS IN PERSPECTIVE

That is at a minimum, 33% to 40% of the entire application approval period to as much as 100% of the time, in which they could have used their pure COVID-19 virus isolates. That is a significant amount of time to have everything you need for your project, sitting in front of you, and it NOT occur to you to use it….and you consider yourself a scientist? So, the real meat of the matter is, who gave the order to not use them?

ITS STILL THERE TODAY

The 7th and current version of that PCR diagnostics document still has that no isolates paragraph in it.

You will notice that the phrase was changed to “since isolates weren't available at the time”, but they were available! It would also be nice to know who the people are that went along with this idea to send out to the world, the subpar version, built with duct tape and bubble gum, instead of the stronger properly perfected version they could have created. Keep in mind this very test drove public health policy across the globe. It was the test used to justify shutting down businesses and schools. It was the test that drove case numbers and in turn created global fear. If they wanted the PCR test to make COVID-19 appear worse than it is, this is how you can do it. Should this be investigated?

MORE PCR FUDGERY

You may recall that shortly after the CDC shipped all its COVID-19 virus isolates to the repository. All the labs using that material were having problems with their tests which were built using the CDC template.

There was supposedly some “contamination” problem with one of the N3 primers. So, the obvious thing would be to fulfill quality control requirements and grab a non-contaminated version to replace the contaminated versions, right? Nope, I guess some folks at the CDC felt that the labs could just come up with their own material and configurations and just throw some more duct tape and bubble gum at the problem…who needs quality control!

Oh well, so much for uniformity and consistency in science.

A FANCY NEW PCR TEST

Then in July of 2021, they announced the retirement of the single PCR test, and the migration to a new multiplex style of test which would be able to detect multiple viruses and save time, material, and expenses. However, when you look at their document you find additional reasons that were somehow magically left out of the press release.

Bold emphasis on important parts are mine...

“During the early months of the Coronavirus Disease 2019 (COVID-19) pandemic, clinical specimens were not readily available to developers of (In Vitro Diagnostics) IVDs to detect SARS-CoV-2. Therefore, the FDA authorized IVDs based on available data from contrived samples generated from a range of SARS-CoV-2 material sources (for example, gene specific RNA, synthetic RNA, or whole genome viral RNA) for analytical and clinical performance evaluation. While validation using these contrived specimens provided a measure of confidence in test performance at the beginning of the pandemic, it is not feasible to precisely compare the performance of various tests that used contrived specimens because each test validated performance using samples derived from different gene specific, synthetic, or genomic nucleic acid sources.

From February through the middle of May, the FDA issued a total of 59 EUAs for IVDs for the qualitative detection of nucleic acid from SARS-CoV-2 based on validation data using contrived specimens derived from SARS-CoV-2 viral RNA.”

If it were just about saving lab costs, you would not need to put all that jibber jabber about performance inconsistencies in there…right? That whole CDC science thing is a quagmire of stupidity and no integrity.

Fact checkers who make excuses for the existence of the “no isolates were available” paragraph or try to “word salad” a reason why the contrived solution was used, only further prove that the science field is broken since none have understood and addressed that isolates were readily available and that the actual isolates (by choice) did not get used.

I have yet to hear a justifiable reason for what the FDA and CDC did between January and February of 2020. However, this is not in my wheelhouse of expertise, so I continue to seek answers on this subject.

Through our mask research, we decided to root cause the pandemic issues, and it led us to issues with the PCR test. My team and I do not have the answers to this issue, but we truly are seeking them to have more clarity. I believe we must know what went wrong and when, and obtain measured accountability so that we can regain confidence in the science integrity of our public institutions.

Reference to July PCR retirement:

https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/sars-cov-2-reference-panel-comparative-data?ACSTrackingID=USCDC_2146-DM61940&ACSTrackingLabel=Lab%20Alert%3A%20Changes%20to%20CDC%20RT-PCR%20for%20SARS-CoV-2%20Testing&deliveryName=USCDC_2146-DM61940