The CDC is Bailing on PCR Tests

We began reporting suspicions about the CPR test for detecting COVID (and its failures) in 2020, but they’ve been the Gold Standard for fearmongering the spread and the curve. Effective December 31, 2021, the CDC will withdraw requests for Emergency Use Authorization with the FDA.

In the CDC’s own words: “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.”

The tests are crap.

Currently, the false positive rate for PCR tests is reported to be at least 5%. This means that in countries such as the United Kingdom, where over 1 million people are being tested daily, around 50,000 people a day are diagnosed as positive for COVID-19 and consequently undergo severe measures such as quarantine and strict isolation, despite not being infected at all. In countries such as Australia, which rapidly transformed into a police state after 400 COVID-19-positive cases were confirmed, false positive results can have dramatic effects.

I can only guess that the cash-cow for PCR tests had died or been replaced with some new bull. Or, the words “emergency use” are no longer relevant, and there’s some useless authorized detection method.

Perhaps folks will use it because the FDA leaves it out there and available, or maybe they approve it, or who even knows at this point.  Science has not been at tor forefront of any of this so we have to assume that anything is possible.

After reviewing the Lab Alert and the links included, there are several links (here and here) related to approved or ongoing test or testing platforms, which don’t mean much to me, but they may to you.

Tables of IVD EUAs:

• • Molecular Diagnostic Tests for SARS-CoV-2
    • Individual EUAs for Molecular Diagnostic Tests for SARS-CoV-2
    • Revision Concerning Viral Mutation
    • Pooling and Serial Testing Amendment for Certain Molecular Diagnostic Tests for SARS-CoV-2
    • Umbrella EUA for SARS-CoV-2 Molecular Diagnostic Tests for Serial Testing
    • EUA for Molecular Diagnostic Tests for SARS-CoV-2 Developed And Performed By Laboratories Certified Under CLIA To Perform High Complexity Tests
  • Antigen Diagnostic Tests for SARS-CoV-2
    • Individual EUAs for Antigen Diagnostic Tests for SARS-CoV-2
    • Revision Concerning Viral Mutations 
  • Serology and Other Adaptive Immune Response Tests for SARS-CoV-2
    • Individual EUAs for Serology and Other Adaptive Immune Response Tests for SARS-CoV-2
    • Revision Concerning Viral Mutations 
  • IVDs for Management of COVID-19 Patients

Templates for EUA Submissions

Templates for EUA submissions for several types of COVID-19 tests are available to help facilitate the preparation, submission, and authorization of an EUA request:

Diagnostic Templates (Molecular and Antigen)

• • Molecular Diagnostic EUA Cover Sheet Template (October 6, 2021)
  • Molecular Diagnostic Template (October 6, 2021)
  • Molecular Diagnostic Home Specimen Collection Template (October 6, 2021)
  • Antigen Diagnostic Template (October 6, 2021)
  • Molecular and Antigen Home Use Test Template (November 9, 2021)
  • Supplemental Template for Molecular and Antigen Diagnostic COVID-19 Tests for Screening with Serial Testing (October 25, 2021)

Serology/Antibody Templates

• • Serology Template (October 6, 2021)
  • Template for Serology Tests that Detect or Correlate to Neutralizing Antibodies (October 6, 2021)

Whatever the deal, the CDC (at least) is walking away from this goose egg of a test, admittedly long after the damage has been done, but I suppose it’s better than where they were or is it?

We’ll know soon enough.

HT | Frontline News