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We are witnessing one of the most extraordinary events in human history, and certainly the most far-reaching and impactful event in all of our lifetimes, because of the effects of what we are being told is a single coronavirus.

Here at Health Impact News, as always, we have endeavored to publish the truth about this pandemic, even if the truth is not popular or censored in the corporate-funded “mainstream” media.

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:

Continue here: Not a Single COVID-19 Test is FDA Approved – Do We Really Know Who has