During the first week of April, Great Britain learned its virus tests had been tainted with "COVID-19"
I looked to see which one of the several test companies were involved and learned it was EUROFIN. I looked to see if they had any offices in the United States, and indeed they are listed under VIRACOR.
I then called Viracor to learn if there was a possibility of contamination in the United States.
On the call, the Director of Regulatory Affairs and Quality Assurance of Viracor Eurofins in the U.S. confirms that their tests are made in the country. He explains why their tests are superior.
Remember there are at least 15 tests being used. Is there a gold standard? All of these tests are listed "not for diagnostic use." You can email me for that proof. Or look on my twitter page.
The RT PCR is also arguably useless as it producing presumptive positives. You would need to read EACH INSERT FOR EVERY TEST FOR ITS "LIMITATIONS"
These tests are not for diagnostic use. They are not FDA-approved. This is MCMEDICINE. You even have drive-thrus.
How is this not a new cottage industry?
Then there are the labs. There are also many helping out with covid19 efforts.
Meanwhile, deaths being misclassified.
More on :
Great Britain Learns its Virus Tests Have Been Tainted with COVID-19
https://www.redstate.com/bradslager/2020/04/01/great-britain-learns-its-virus-tests-have-been-tainted-with-covid-19/
Viracor Rep also talks about Emergency Authorization Use and Clinical Laboratory Improvement Amendments. These may seem like pesky details but this is where you learn what allowances and corner-cutting these government organizations have under emergency status.
The Emergency Use Authorization (EUA) authority allows FDA to help strengthen the nation’s public health protections against CBRN threats by facilitating the availability and use of MCMs needed during public health emergencies.
Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA Commissioner may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when there are no adequate, approved, and available alternatives.
Section 564 of the FD&C Act was amended by the Project Bioshield Act of 2004 and was further amended by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), the 21st Century Cures Act of 2016, and Public Law 115-92 of 2017.
Clinical Laboratory Improvement Amendments (CLIA)
The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA). In total, CLIA covers approximately 260,000 laboratory entities. The Division of Clinical Laboratory Improvement & Quality, within the Quality, Safety & Oversight Group, under the Center for Clinical Standards and Quality (CCSQ) has the responsibility for implementing the CLIA Program.
The objective of the CLIA program is to ensure quality laboratory testing. Although all clinical laboratories must be properly certified to receive Medicare or Medicaid payments, CLIA has no direct Medicare or Medicaid program responsibilities.
https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA
Please note these regulations are called forth because of a supposed state of emergency.
In CA, for instance, you can call a state of emergency based on only three cases. A state of emergency was declared in Costa Rica after two cases of supposed Covid19 cases.
Viracor is listed on the FDA’s FAQ found here: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-diagnostic-testing-sars-cov-2#whatlabs
Specifically click on this question on the page: Q: What laboratories are offering testing under the policy outlined in Section IV.A of the Policy for Diagnostic Tests for Coronavirus Disease-2019?
I try to focus on specifics. Devil is in the Details.
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