Not a Single COVID-19 Test is FDA Approved – Do We Really Know Who has COVID-19 and Who Does Not?

This article being published today, on May 5, 2020, might be the most significant article about COVID-19 that we have published on the topic to date.

The rationale for the extraordinary events we are seeing today all come down to one dataset: the amount of people infected with this coronavirus, and the rate at which people are dying from it.

This can only be justified by one simple fact: that we know how to identify and test for this single virus.

If this single fact cannot be proven, or if it is proven to be false, and we really do not have the means to accurately test for this virus, then everything that has transpired as a direct result of trusting the data that this test is based upon, has been built on a faulty foundation that does not exist.

Does this sound like a conspiracy theory? Because if you dare to ask the question, that is what you will be accused of for daring to question the accuracy of the tests, and therefore the accuracy of the data that these tests allegedly prove.

So let’s start with the facts that most everyone agrees upon, or that can be easily verified.

FACT #1: The FDA has NOT Approved a Single Test for COVID-19

This was brought to my attention recently by someone who contacted me who has 43 years of clinical diagnostics experience. In addition to being a Med Tech at one of the New York City metropolitan area’s largest reference laboratories, this person spent 25 years of that 43 working for medical device manufacturers as a biomedical field service engineer and technical consultant. They installed, repaired, troubleshot and validated laboratory instrumentation.

This person wishes to remain anonymous, but this is what they wrote.

FDA emergency Use Authorization and COVID-19 Testing

by a 43-year Veteran of Clinical Diagnostics

Since the beginning of the COVID-19 “Pandemic”, much of government and the media’s focus have been on the need for more testing.

The purpose of this brief article is to examine the FDA’s Emergency Use Authorization (EUA) and the effect these authorizations have on the reliability of test results in identifying positive/negative samples for COVID-19.

Per the FDA website:

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 (Chemical, Biological, Radiological and Nuclear) threat agents when there are no adequate, approved, and available alternatives. (Source.)

The key word in this statement is “unapproved.”

Medical device manufacturing is one of most highly regulated industries in the US. The FDA approval process for a medical device takes years.

To date there are no COVID-19 diagnostic tests being used that have completed a full FDA approval process.

The reason they have not received FDA approval is because the safety and effectiveness of the product has not been proven. Many of these tests have been developed at least since the SARS outbreak of 2000-2004.

Refer to the above FDA website video explaining the EUA process.

Pay particular attention to the statement:

“It is not in the best interest of Americans for the FDA to allow the use of a test that doesn’t work as it should. False test results can contribute to the spread of an infectious disease like COVID-19.”

In reviewing the list of In Vitro Diagnostics products on the FDA website that have received Emergency Use Authorizations, the FDA is contradicting its own claim and is authorizing the use of diagnostics tests that produce false results.

There is a very easy way to confirm this statement, if you know where to look.

From the list of In Vitro Diagnostic products that have received a EUA, select any manufacturer. Go to that manufacturer’s website. Select the test from the products listing.

Look for the “package insert”. The package insert explains everything you need to know about the test, including its intended use, performance and interpretation of results.

Using the ROCHE cobas® SARS-CoV-2 test from the list, go to the Roche website and read the emergency use statement:

Results are for the detection of SARS-CoV-2 RNA that are detectable in nasal, nasopharyngeal, and oropharyngeal swab samples during infection.

Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses.

Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.

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. (Source.)

The media has also been reporting a shortage of COVID-19 test kits. The CDC has made recommendations on prioritizing patients based on need.

The media makes it appear that anyone can get a nasal swab and get tested. All you need is the result from that swab and you can find out if you are positive or negative for COVID-19 as this Fox News Report implies:https://www.youtube.com/embed/DbiCwYhZnGo?feature=oembed&enablejsapi=1

This is far the truth.

This article by ARUP Laboratories: “How Accurate Are COVID-19 Tests? Many Factors Can Affect Sensitivity, Specificity of Test Results explains.

Due to internet censorship, articles on research that don’t conform to the current narrative are difficult to find but not impossible. The individual research papers are available by accessing the provided links.

The samples that were tested as part of these research papers were performed in a closed environment, meaning, collection, testing and results interpretations were all done on the same site.

What happens to the validity of test samples that are collected at one location, sent to a local health department, because of insufficient testing capabilities, sent to reference lab and from there sent to an affiliate lab location?

The CDC website has guidelines here.

In summary, the Government and the Media used fictional statistics on the severity of the COVID-19 “pandemic” to instill fear in the US population, shut down entire industries and trash a thriving economy.

State’s Governors forced draconian “shelter in place” orders falsely claiming the necessity to “flatten the curve.”

These same Governors are now claiming the need for mass, unproven antibody testing, those tests receiving FDA EUA, before States can “safely” open up again.

At least there is more reporting on the fallacies of antibody testing then there is on the testing for COVID itself.

Dr. Fauci is already warning of a COVID-19 resurgence this fall.

——————-

FACT #2: The Drug Companies Themselves are Arguing Over Which Tests are Accurate and Which Ones Are Not

FACT #3: “Official” Statistics on COVID-19 Deaths Vary Widely Depending on Who You Trust

The corporate media presents daily updates on COVID-19 deaths as if it they were universally accepted as accurate.

But did you know that as of this past weekend, the media’s statistics for COVID-19 deaths were more than 29,000 HIGHER than what the U.S. CDC was reporting?

The media is NOT using CDC statistics to report COVID-19 deaths. They are mainly using statistics from a website called Worldometer.

The number of deaths being reported at the Worldometer website have consistently run about 60% higher than what the CDC website has been publishing.

And as we have previously reported, many doctors and others have come forward to explain that the CDC guidelines for reporting CDC deaths is very liberal, because almost anyone coming into the hospitals right now is automatically counted as COVID-19 patients, and even if they had pre-existing conditions such as heart disease or cancer, they are being reported as COVID-19 deaths.

So the CDC numbers are admittedly high. See:

According to the CDC, COVID-19 deaths reached a peak the week of April 18th.

But according the media, deaths are still increasing and have not even peaked yet, based on the stats they are using from the Worldometer website, which has deaths almost twice as high as the CDC’s padded numbers, and these numbers are the ones being used to instill fear into the American public.

Who Runs the Worldometer Website?

The answer to the question as to who operates the Worldometer website, the website that almost the entire corporate media (and some in the Alternative Media as well) is publishing as fact, seems to be shrouded in mystery.

The Worldometer website claims this about the site:

Worldometer is run by an international team of developers, researchers, and volunteers with the goal of making world statistics available in a thought-provoking and time relevant format to a wide audience around the world. It is published by a small and independent digital media company based in the United States. We have no political, governmental, or corporate affiliation.

That’s it. No names of the people operating the website, and they do not identify the “small and independent digital media company based in the United States” on their own website.

It takes some digging to find out the name of the company who owns the Worldometer website, and it is Dadax. They appear to have a single page website which says:

Dadax is a US-based and American owned small digital media company.

It was founded over 15 years ago.

We are the publishers of Worldometer.

That’s it.

When searching for more information about this company, it is difficult to find much else. There is a company of the same name in China, but they have publicly stated that they have no affiliation with the U.S. company by the same name.

There is a Dadax, LLC company listed in Delware that is listed as a “Foreign Limited Liability Company.”

According to this listing, it is managed by two persons, and the principle person is DARIO PASQUALINO. But there are several other “related companies” with the same name. (Source.)

Interestingly, the Worldometer’s website was attacked by cyber attacks in March, as someone apparently wanted the website to come down. (Source.)

Because the data on Worldometer is almost identical to the Center for Systems Science and Engineering (CSSE) website at Johns Hopkins University, it is possible that the data source for both sites are the same.

Lauren Gardner, an epidemiologist and co-director of the Center for Systems Science and Engineering at Johns Hopkins University, is credited with developing the dashboard that is mirrored on the Worldometer website.

Guo Meiping, writing for the China Global Television Network (CGTN) in an article titled: “Why does U.S. COVID-19 data come from a university not the government?“, states:

The entire concept and visualization of the (Johns Hopkins University) dashboard were prepared by a civil and systems engineering professor, Lauren Gardner, and two Chinese students, Dong Ensheng and Du Hongru – both first-year Ph.D. students at the University’s Center for Systems Science and Engineering.

Dong told a local Chinese media outlet that on March 12, the dashboard got two billion hits from the entire world in a single day. They also co-authored a short piece explaining the dashboard, which was published on the world-leading medical journal The Lancet on February 19.

At this point, who owns Worldometer is still a mystery. It appears to mirror the dashboard at Johns Hopkins University, but it is not clear from which site the data originates.

If anyone has any further information, please provide it in the comments section.

Conclusion: Do the Facts Support the Belief that we Have an Accurate COVID-19 Test to Know Who is Dying from COVID-19 and Who is Not?

So just to review the facts about COVID-19 tests and the data based on those tests that tells us who died from COVID-19 and who did not:

Fact #1 – There is not a single test on the market for COVID-19 that has been approved by the FDA.

Fact#2 – Pharmaceutical companies argue among themselves as to who has accurate COVID-19 tests and who does not.

Fact#3 – Official statistics from the CDC, who admittedly pads their numbers to include those not tested or assumed to have COVID-19, are vastly lower than what the media is reporting, which uses statistics from a website called “Worldometer” that nobody seems to know who owns, or how the data is compiled.

Those are the facts that are verifiable.

So if there is no accurate test for COVID-19, what is really going on?

Let the conspiracy theories begin….

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