FDA Criticized as COVID Tests Still not Accurate, But U.S. Starts Second Lockdown Anyway

COVID-19 blood analysis, with different answers. Set of glass capsules field with patient blood and white information labels, isolated on background. Corona virus vector illustration.

by Brian Shilhavy,

The corporate media news cycle this week is once again promoting fear in the American population by claiming that COVID cases are again on the rise in “hot spots,” prompting calls for more lock downs and other measures, including many states now requiring people to wear face masks in public.

Two key pieces of information are missing from almost all of these reports in the corporate media: death rates (even by their own statistics) are NOT increasing but holding steady or even decreasing, and inaccuracy with the tests themselves are still widespread.

report earlier this month out of Wichita Falls, Texas, for example, revealed that testing of residents and staff at a medical facility revealed many positive results, but since none of them were sick, they retested 20 of them, and the second test result was negative in all 20 of them.

In a Facebook post Monday night Sheridan Medical Lodge reported that 78 residents and staff members tested positive for COVID-19 during routine testing conducted on May 25 however after retesting 20 staff and residents the test came back negative.

According to the post, 46 residents and 32 staff members tested positive during routine facility testing.

All positive cases were asymptomatic. According to the post, it is unusual for cases at a nursing facility to not show any symptoms which prompted a retest of 20 residents and staff.

The results of all 20 retest have come back negative for COVID-19. (Source.)

The national corporate media franchises would probably never publish something like this, because it doesn’t fit their narrative for the Plandemic.

They do report inaccuracies with testing, however, if it does fit their narrative, meaning that tests are inaccurate in the sense that there should be more positive results, especially if it is a test promoted by President Trump, such as Abbott’s fast COVID-19 test.

FierceBiotech, a pharmaceutical marketing publication, reported:

In mid-May, the Food and Drug Administration issued a rare public warning about an Abbott Laboratories COVID-19 test that for weeks had received high praise from the White House because of its speed: Test results could be wrong.

The agency at that point had received 15 “adverse event reports” about Abbott’s ID NOW rapid COVID-19 test suggesting that infected patients were wrongly told they did not have the coronavirus, which had led to the deaths of tens of thousands of Americans. The warning followed multiple academic studies showing higher “false negative” rates from the Abbott device, including one from New York University (NYU) researchers who found it missed close to half of the positive samples detected by a rival company’s test.

But then, in a move that confounded lab officials and other public health experts, a senior FDA official later that month said coronavirus tests provided outside lab settings would be considered useful in fighting the pandemic even if they miss 1 in 5 positive cases—a worrisome failure rate.

The FDA has now received a total of 106 reports of adverse events for the Abbott test, a staggering increase. The agency has not received a single adverse event report for any other point-of-care tests meant to diagnose COVID-19, an agency spokesperson said.

In a statement, Abbott Laboratories said the NYU research was “flawed” and “an outlier,” citing studies with higher accuracy rates.

Though the Abbott rapid test is one of over 100 COVID-19 diagnostic tests to receive FDA emergency use authorization during the pandemic, President Donald Trump has featured the product in the White House Rose Garden, and the Department of Health and Human Services’ (HHS’) preparedness and response division has issued more than $205 million worth of contracts to buy the test, according to federal contract records. (Source.)

About the only truth the public can ascertain from all of these conflicting reports is, the COVID tests simply are not accurate.

As the FierceBiotech publication noted, over 100 COVID-19 diagnostic tests have received FDA emergency use authorization to fast-track them and bring them to market.

That means ZERO COVID tests have gone through the full approval process to bring a test to market, which would normally take years.

As I reported back in May, someone 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 has 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:

This is far from 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.

States’ 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.

——————-

The REAL Crisis is Happening Among our Seniors in Assisted Living Facilities

Estimates are that 30% to 50% off all reported COVID deaths are among seniors in assisted living facilities.

Investigative reporter Jon Rappoport reported on this issue this week, and asked the question:

Who cares about all the old people dying?

COVID: Behind the global nursing home disaster, and the case-number scam

by Jon Rappoport

Scandal. Tragedy. Ongoing crime.

In nursing homes, elderly people are already on the edge of the cliff, suffering from long-term illnesses and years of toxic medical treatments…but now you terrify them with COVID propaganda…then you actually label them “COVID”, WITH NO JUSTIFICATION…then you isolate them completely…they’re all alone…no contact with family and friends…what do you expect will happen to these fragile, heavily drugged people?

As of May 22, Forbes reports that, “…in the 43 states that currently report such figures, an astounding 42% of all COVID-19 deaths have taken place in nursing homes and assisted living facilities.”

Washington Post, May 18: “The World Health Organization said half of Europe’s covid-19 deaths occurred in such facilities.”

Headline of same Post article: “Canada’s nursing home crisis: 81 percent of coronavirus deaths [in the country] are in long-term care facilities.”

The Guardian, May 16: “About 90% of the 3,700 people who have died from coronavirus in Sweden were over 70, and half were living in care homes, according to a study from Sweden’s National Board of Health and Welfare at the end of April.”

“Spain—The country was shocked at the end of March when the defence minister revealed that soldiers drafted in to disinfect residential homes had found some elderly people abandoned and dead in their beds.”

“…the regional governments of Madrid and Catalonia have been publishing their own figures on people who have died in care homes from the virus, or while exhibiting symptoms consistent with it.” [AKA, absurd eyeball diagnosis]

“In Madrid, the total for Covid, or suspected Covid, deaths since 8 March stood at 5,886 on Thursday. In Catalonia, it was 3,375. Between them, care home deaths in the two regions account for more than a third of all the coronavirus deaths in the country.”

And there was a great deal of early warning on the subject, if anyone from public health agencies wanted to pay attention—The Guardian, 13 April: “About half of all Covid-19 deaths appear to be happening in care homes in some European countries…Snapshot data from varying official sources shows that in Italy, Spain, France, Ireland and Belgium between 42% and 57% of deaths from the virus have been happening in homes, according to the report by academics based at the London School of Economics (LSE).”

There are two con jobs going on here, as huge numbers of these elderly patients have died and are dying.

The first is the COVID-19 diagnosis, which is either made on the absurd basis of simply eyeballing the patient and seeing general signs of illness, such as shortness of breath and flu-like symptoms; or by test, which I’ve explained is completely unreliable, because it registers positive on all sorts of germs in the body that are irrelevant.

But once the COVID diagnosis is made, then medical authorities claim the deaths of so many patients in nursing homes are occurring because the COVID virus naturally has more impact on the elderly and infirm.

Nonsense. There is no need to invoke the coronavirus to explain why these people in nursing homes are dying.

People all around the world, old people, who have traditional illnesses like flu and pneumonia, are being repackaged as COVID cases. Especially people in nursing homes, who are terrified by COVID propaganda and are intentionally isolated from friends and family…

And in fact are dying of their long-term multiple medical conditions, plus years of treatment with toxic drugs…

Plus the terror of COVID, plus complete isolation, plus filthy conditions in some facilities, plus inattention and outright brutality on the part of nursing home staffs, plus breathing ventilators and sedation in some cases —

Not a virus.

No need to invoke a virus as an explanation.

No need at all.

Obviously, if you subtracted all these deaths from official COVID statistics, you would have a completely different picture of the so-called pandemic.

YOU WOULD HAVE A WORLDWIDE NURSING HOME DISASTER.

And the first order of business would be to go into these places and clean them up and straighten them out and in many cases make arrests of the personnel.

As a number of nursing home patient-advocacy groups have pointed out, the main monitor on what goes on in these homes, and the main source of protection for patients is: visiting families and friends, who keep a careful eye on things.

But because the fake COVID diagnosis immediately leads to locking down the facilities, friends and families can’t come in. They’re shut out.

For the planners of this false pandemic, it all works out. COVID death numbers rise, case numbers rise. Phony numbers to the core.

But real and tragic deaths.

People pushed into death by the concocted IDEA of a virus, by a STORY about a virus.

SOURCES:

* https://www.forbes.com/sites/theapothecary/2020/05/26/nursing-homes-assisted-living-facilities-0-6-of-the-u-s-population-43-of-u-s-covid-19-deaths/#12d6083874cd

* https://www.washingtonpost.com/news/powerpost/paloma/the-health-202/2020/05/19/the-health-202-the-hopeful-news-about-moderna-s-coronavirus-vaccine-is-extremely-preliminary/5ec2e480602ff11bb118504f/

* https://www.washingtonpost.com/world/the_americas/coronavirus-canada-long-term-care-nursing-homes/2020/05/18/01494ad4-947f-11ea-87a3-22d324235636_story.html

* https://www.theguardian.com/world/2020/may/16/across-the-world-figures-reveal-horrific-covid-19-toll-of-care-home-deaths

* https://www.theguardian.com/world/2020/apr/13/half-of-coronavirus-deaths-happen-in-care-homes-data-from-eu-suggests

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2 thoughts on “FDA Criticized as COVID Tests Still not Accurate, But U.S. Starts Second Lockdown Anyway”

  1. Because everyone has the virus from the meat they have eaten, or from infected breast milk passed down throughout the ages from people who ate meat. It depends upon what part of the blood stream is being tested whether it is positive or negative. Lymph would be a better test – and a great deal more painful – because it is the lymph that takes what is not healthy from the blood to the lymph nodes so the problem can be removed when the individual becomes aware of the problem. This is also true of cancers. Lumps are formed, from the contents of the lymph, when the nodes are full and there is weakness in an area where the sacred energies are blocked.

    Our immune systems are powerful, conscious and sacred. Work with them, don’t destroy them with vaccines, toxic pharmaceuticals and slow-poison-fast-foods, etc.

    Reply
  2. I once went to a hospital to visit a friend and when the doctor came in, I made a few not very supportive comments about how diseases are treated in hospitals and the doctor said to me: (He was using one of the many machines they hook individuals up to) “These machines are NOT accurate.”

    And, I have always felt the blood sugar tests were ‘not accurate’ because the blood sugar is affected by what the individual ate and drank and her/his emotions at the time. How sad we give our power (of knowing – after all it our bodies we live in – to an authority figure in a white coat and it is we who are in charge of how it is used.) One moment our blood sugar is high because of a negative, fearful thoughts, and the next, level because of the peace we are feeling. Self-mastery is the best medicine.

    I had another friend who told me that the doctor told him that rice should not be eaten because it keeps the blood sugar even. My comment to that remark was “So he can get rich on the slow-poison insulin he is selling you.” A very toxic and not natural insulin that slowly creates pancreatic cancers. (Ask a nurse what it is like to work day after day hearing the screams of those dying from pancreatic cancers!)

    Reply

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