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Lab Alert: Changes to CDC RT-PCR for SARS-CoV-2 Testing

My Chart Drawing Skills Are Unmatched

I ate a wood-fired double pepperoni with onion pizza from a local place late yesterday afternoon, delivered by Grab Food (20 minutes), $9. First food of the day. But, I also had whiskey in me, for hours. Just enough to be in that right place; where, I’m booze-buzzed and hungry, but the hunger is real. I don’t know the number of hours, but it was at least 18 at that point with no food.

I live by a simple rule: like booze and food, but not together. In other words, eat OR drink. Combining them is what makes you truly awful.

So I set down the whiskey and began the food phase.

…I get up very early most days, 4-5am. A few cycles of that, then I get feeling bedtimes at 8pm or so. I go with it. But, what typically happens is that I wake up fully sober and alert at 1-2am, get up, and this is my TV Netflix time. So, for instance, last night I went to bed about 8, got up at 2, finished watching “Faster” with Rock and Thornton, then got about halfway through the Crow adaptation of “Robin Hood.” Back to bed at 4.30, up about 7, coffee.

Then I see this, posted by Ari Whitten on IG and FB:

WTF? If true, I instantly made all the rabbit-hole connections in the seemingly instantaneous ways a 10-100 terabytes brain can make, recent inebriation notwithstanding.

Ari provided this link: 07/21/2021: Lab Alert: Changes to CDC RT-PCR for SARS-CoV-2 Testing.

Audience: Individuals Performing COVID-19 Testing

Level: Laboratory Alert

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.

Visit the FDA website for a list of authorized COVID-19 diagnostic methods. For a summary of the performance of FDA-authorized molecular methods with an FDA reference panel, visit this page.

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.

I added the bolded phrases for better between-lines reading. This was the original test everything flowed from beginning in February, 2000. The second bolding is ambiguous. You can’t tell whether it’s implying that this Covid test couldn’t tell a Covid from a flu, or that it would be best to have a test that tells you which is which. In either case, I have already noted in previous posts that one of the amazing things about this virus is that from about April, 2020, it cured almost all influenza worldwide, since there is virtually zero reporting of a single instance of flu in any country on earth—a disease that kills 300-600,000 annually—in the WHO’s own database.

But, even damning enough, it didn’t really contain the exact words that image did, so I spent time in due diligence.

I did not find that the USFDA said that, explicitly. My bad?

What I discovered is was what I believe is worse. For instance…

“Removal Lists of Tests That Should No Longer Be Used and/or Distributed for COVID-19: FAQs on Testing for SARS-CoV-2”

Instead of just linking the text, here it is:

https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/removal-lists-tests-should-no-longer-be-used-andor-distributed-covid-19-faqs-testing-sars-cov-2

Now, get your SCUBA gear on and dive.

What you will find is that three companies have been given the Out-Of-The-Pool flag, and, a total of 286 Covid-19 tests have been declined.

286!!!???

Does that raise a question in you? That there were nearly 300 test for Covid that HAD Emergency Use Authorization, but that they have been revoked?

OK, that’s problematic, but let’s just move on, right? Nothing to see here.

But how many are left?

Coronavirus (COVID-19) Update: July 23, 2021

Testing updates:

As of today, 395 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 279 molecular tests and sample collection devices, 86 antibody and other immune response tests and 30 antigen tests. There are 52 molecular authorizations and one antibody authorization that can be used with home-collected samples. There is one molecular prescription at-home test, three antigen prescription at-home tests, five antigen over-the-counter (OTC) at-home tests and two molecular OTC at-home tests.

The FDA has authorized 11 antigen tests and eight molecular tests for serial screening programs. The FDA has also authorized 586 revisions to EUA authorizations.

So what bigger question does that raise in you?

Out with the old, in with the new?

But why?

Is it because the Emergency Use Authorization is restrictive enough?

I think that’s the key. It was surely designed to be pretty restrictive, I’m sure, but is that even remotely what’s going on? Or, is it that if it says “Covid” somewhere on the box, carte blanche?

EUA is likely a pretty good standard for time-to-test problems, and anyone with any brains can see why that’s necessary to have. Of course, we want any drugs we take upon advice and prescription of our professional physicians to have been tested to rational norms of risk and reward; and it is up to your physician to help you sort out your personal and private decision based upon his assessment of all of that, given his own examination and diagnosis of you as an individual patient.

It’s never going to be perfect, but it’s the best you can get for reasonable expense.

And it’s usually pretty fucking good.

Are these Covid-19 tests Pretty Fucking Good?

So, the FDA just canned 286 of them. End of story?

Grasshopper, no.

395 tests still out there, as I linked just above. Did you also note that they have issued 586 “revisions to EUA authorizations?”

What does a ‘revision to an emergency’ mean?

Still an emergency, but qualified? How, exactly?

We are at a point where this doesn’t matter for the 90% who just want to be told what to do so they can do it. You understand that, right? On the other hand, this offers a bit of a jolting reality. Still a long shot given the general intransigence. For a lot of people, Covid is the best thing that ever came along. They calculate their own values along those lines…

…I fully understand that to get even close to any bottom, one would need to look closely at every one of those 286 tests that failed, got their EUA revoked. Questions like:

  • How long were they feathers in the wind?
  • What “data” did they produce?
  • What political and public policy decisions were made based upon the data produced by those “tests?”
  • What general social costs can be accounted for?

I could go on, but you get the idea.

Has Emergency Use Authorization been exposed, now, as a Revolving Door?

See, at first, I was all giddy. But I did the SCUBA dive and realized that I’m not seeing this in the news because it’s just a herring among lots of herring.

What’s the Occam’s Razor idea if you have 286 COVID!!! tests that have been killed, BUT, 395 of them still A-OK, no guarantees? How many of the 395 left will prove the pudding or be tossed out as past?

My Occam’s idea is that EUA is being completely corrupted through inundating the FDA with applications and since they are probably differentiated from each other by cunt-hair specifications, they can get a EUA and enjoy some months of sales, distribution, and profits before being shut down.

If that’s a fair quick look and assessment, do you think that’s in keeping with the spirit and the law, honestly?

It’s up to you.

Richard Nikoley

I'm Richard Nikoley. Free The Animal began in 2003 and as of 2021, contains 5,000 posts. I blog what I wish...from health, diet, and food to travel and lifestyle; to politics, social antagonism, expat-living location and time independent—while you sleep—income. I celebrate the audacity and hubris to live by your own exclusive authority and take your own chances. Read More

5 Comments

  1. Currin on July 26, 2021 at 01:45

    I can’t make sense of this.

    ~300 or possibly ~600 different tests have been cleared for Emergency Use Authorization???? Why so many? How is any kind of data collection or analysis possible with so much variety? If a couple of them worked, why keep developing more? What on earth was the assessment process for these?

    I was a Microsoft Office continuing Ed instructor back in the 90s. I designed and taught an Excel class, “How to lie with charts.” It’s really not hard to tell the story you want to tell, with jiffy-looking charts to back up your premise, regardless of the “data” available.

    Statistics and some kind of, “daily life data analysis” really should be part of our core curriculum.

    • Richard Nikoley on July 26, 2021 at 07:37

      How can you possibly have any confidence that the results being put out are reasonably sound?



    • Keith on August 18, 2021 at 10:00

      If a couple cars work why keep developing more? Why keep developing better ones? Cmon dude….the government created a multi billion dollar market overnight and countless bio/chem/pharma outfits wanted a slice of the pie so they each developed their own and got EUA fast tracked. Pretty straightforward Occam’s explanation as Richard offered.



  2. Tim on August 3, 2021 at 18:09

    I warned people about this from the beginning when people said “mask eliminate the flu”

    No the flu was being reported as Covid, period

    Good article and Currin (Guy who replied here) is right about telling any lie or conclusion you want/need through stats.

    Businesses, Wallstreet, governments lie/hide through stats daily

  3. Natalie on August 11, 2021 at 23:22

    They actually admitted the virus wasn’t even isolated when the test was created. So when DID they isolate it? No one has found any proof so far. Jon Rappoport was the first (to my knowledge) to be skeptical about the virus’s existence (since they pulled the same stunt with the AIDS/HIV and he reported on it back in the day). Sally Fallon and Andy Kauffman investigated that, too.
    https://www.naturalnews.com/2021-08-08-hhs-documents-admit-the-cdc-has-never-isolated-any-covid-19-virus-global-hoax.html#

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