Home COVID Testing Blocked By FDA

July 30, 2020

Red tape is once again preventing the deployment of tests that could get our economy back up and running. Action Alert!

The COVID-19 pandemic has had a profound impact on the American economy, but innovation may offer a way out: simple to use, at-home COVID-19 tests could allow businesses and schools to resume normal operations. Unfortunately, the FDA is standing in the way, insisting that a certain threshold of accuracy be attained. This reliance on bureaucratic red tape is what marred the agency’s early response to COVID-19 testing, and it seems as though the agency has not learned its lesson. The FDA needs to get out of the way so these rapid tests can be deployed.

Writing in The New York Times, Professor Laurence Koltikoff of Boston University and Michael Mina of Harvard’s T.H. Chan School of Public Health describe new testing being developed by several companies (credit also to John Goodman of the Goodman Institute for alerting us to this story). One is a paper-strip test that is inexpensive and can be used every day. You simply spit into a tube, insert a small piece of paper embedded with a protein, and if you’re infected, the strip of paper will change color within 15 minutes. The price per person would be between $1 and $5 dollars a day. Infections could then be confirmed with the polymerase chain-reaction (PCR) swab test, and infected individuals would quarantine until the daily test turned negative.

Individuals could take time-stamped photos of daily negative tests to return to work or school, or for admission into movie theaters, restaurants, or other businesses.

These daily tests are not as accurate as the PCR nasal swab tests currently being used. The rapid tests catch an infection at its peak, but they may not be sensitive enough to detect the virus in a person who is in the early or late stages of infection, when viral loads are lower and the chance for spreading the virus is smaller.  According to Mina, “As long as you’re using the test on a pretty frequent basis, you will be more likely than not to catch the person on the day they might go out and transmit. And they’ll know to stay home.”

But the FDA is blocking the widespread deployment of these tests. Recently, the agency released approval criteria for at-home COVID tests, noting that, “While the recommended sensitivity for these non-lab tests is lower than lab-based tests, the tremendous benefits of broader access to simple and fast testing options generally outweighs this risk.” It is an interesting assertion, given the guidelines provided by the FDA are a mere five percent lower than the sensitivity required by PCR and other molecular tests. According to Michael Mina, these new standards will still block innovation: “The software [required by the FDA guidelines] alone will pose an incredibly large hurdle for many. Unfortunately the template does not offer this type of ‘new’ avenue that I think is going to be necessary if we want to see truly $1 daily tests become a reality.”

To us it seems like the FDA made superficial changes to the requirements for at-home tests so the agency could boast that it is allowing for innovation, when it is doing anything but.

The PCR test may be more accurate, but it has many other problems. The test is expensive ($50-$150), it causes discomfort, you need to go to a lab or other location for a technician to perform the test, and then you need to wait five days to a week or longer for results—during which time you might be spreading the virus if infected or you may even contract the virus, rendering the test results useless. All of this explains why few people are actually getting tested: the CDC has reported that nine of ten infected Americans never get tested.

In short, the FDA has overseen the creation of a fairly accurate COVID-19 test that few people are using. New rapid tests could allow us to test large numbers of people cheaply and safely so we can begin to reopen the economy. Why is the FDA standing in the way?

This isn’t the first time the FDA, charged with protecting and promoting public health, has bungled the response to COVID-19 by inflexibly applying bureaucratic rules and preventing companies from innovating. This has to stop.

The FDA’s mismanagement of the COVID testing situation follows a pattern of ineptitude:

  • FDA is actively attempting to ban bioidentical estriol and other hormones critical for women.
  • FDA is working to destroy homeopathic treatments.
  • The FDA and their partner in crime, the FTC, are gagging doctors and clinics from telling their patients and the public about natural methods of treating and preventing COVID-19, for which there are no effective pharmaceutical treatments.

We need to reform a healthcare system that not only bars the use, but even the mention, of natural remedies like compounded bioidentical hormones that have not been, and never can be, put through the multi-billion dollar FDA approval process, because as natural substances they cannot be fully patented.

Action Alert! Sign our petition for lawmakers to address the many ways that federal cronyism undermines our health. Please send your message immediately.

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23 responses to “Home COVID Testing Blocked By FDA”

  1. j c says:

    It’s never the time for this insider, good ole boy crap but especially now when our nation is under attack… by a wannabe tyrant and a highly contagious disease.

  2. Rick Cox says:

    This is absolutely ridiculous and is being backed and pushed by big pharma and those in the NIH and CDC.

  3. Alan8 says:

    “The FDA’s mismanagement of the COVID testing situation follows a pattern of ineptitude”

    No, the SABOTAGE of America’s response to the virus is intentional. The billionaires have a generations-long hatred of the government taking their tax dollars, and spending them on the non-wealthy.

    The spread of the virus will reduce the number of “useless eaters” that would receive their tax dollars through the government. This is class war.

    #ChargeRepublicansWithMurder

    • Java O Ray says:

      Do you really think the RICH in CONGRESS AREN’T IN ON THIS???

    • Rattlerjake says:

      Oh bull-! The Rich make their millions off of the general population. This article is a ridiculous as they come. Covid19 has been proven, over and over to be less dangerous than the common cold! The people dying, are the ones who would have succumbed to the annual flu and died or died of their existing medical problems. In this instance I agree with the FDA simply because it has already been shown all of the other testing has been pitifully inaccurate and/or the results misreported/misused. Additionally, the approval of an at home test will make it easier for the CDC and HHS to mandate testing, just like they are mandating wearing of USELESS masks! Then expect the cost to increase, and watch for a mandate for a bogus vaccine. It should also be question as to whether these tests are anti-body based — if so they are useless for the first 14 days of infection.

      The saddest part of this whole sham is that it shows just how gullible and ignorant the majority of the general population is, and how easily they will pressure everyone to be forced to adhere to unproven, and unnecessary mandates which violates our basic rights. If we have done nothing more that limit immigration since the start of this crap, we would already have seen it go away naturally, just as the annual flu does, because we would have “herd” immunity.

      “The trouble with our the general population is not that they’re ignorant; it’s just that they know so much that just isn’t so!”

      • PB says:

        Agreed. Unfortunately this is nothing but a horrendous sham.

      • Veda Woo says:

        Yes! A Bogus vaccine…there has Never Been ANY Corona Virus vaccine…NOT One and they began maybe before the 60s to try to make cold vaccines. They spent Millions and years trying to make a vaccine for SARS.
        They couldn’t do it!
        The vaccine may not have meant to be for C-19.
        They may have planned FunVax ( google Wikipedia) and the Rice University Quatum-Dot Tatoo….without which you can not buy or sell…..explaining why they Don’t want a home kit that takes away this plan!

  4. Alexander says:

    one test which effect life must be accurate and not cheap and unreliable, imagine a false negative could cause a start of multiple new infection, therefore if the FDA is insisting to use just reliable test is correct

  5. Greg Gumina says:

    Home testing for COVID-19 should be available to everyone so as to isolate the problem so that when they find a vaccine it will be easily accessible to everyone who needs it.

  6. Bharat Adarkar says:

    Address the many ways that federal cronyism undermines our health.

  7. Clark Easter says:

    you fail to say whether these tests are antibody based or not. Almost all of these at home tests are. If they are antibody based, they will not show infection in the early days – maybe for as long as 14 days from the point of infection. They are therefore fairly useless to stop the spread of the virus. They also do not show whether you are currently infectious or not. They are more useful later to show if there is potential immunity in someone – meaning that I can now go to work with much less fear of catching it. That is useful. You also discount the accuracy factor. Many of the at home tests are VERY inaccurate, with very high rates of false positives and false negatives. They are confused by the presence of other prior viruses in the patient’s body. I do not think this is a case of the FDA being too tough!

    What I am waiting for is a high quality antigen test that could be taken at home. If you actually know of one, let us know. That would actually allow early detection of the infectious stage of the virus.

  8. Linnea Stevenson says:

    Personally, I’m against mass testing. More and more we’re hearing about results that are false positives and positive results for people that never had the tests. Why would I trust an at home test? Especially when there are so many types of coronavirus that are preventable or can be treated naturally.

  9. Sally Warner says:

    Do your job! Cut the red tape and get those home testing kits out for everyone!

  10. John says:

    Most practical method to test put forth !

  11. Charles R Shelly says:

    Please come up with an easy way to share these Action Alert letters on facebook and other social media. This COVID-19 Home Test letter, which actually got into a lot of frankly more important issues about our broken “health” care system, was brilliant, well-written and covered a lot of territory. But there is no good way to share it! And it needs good graphics/photos/headlines in order to attract as much attention as possible.

  12. Ms says:

    Do you really think a PCR test which cannot detect viruses whether done at home or in a parking lot of a county building should be promoted? I’m not writing to the FDA to support ANY PCR test or ANY Antibody test. The fact is….the Coronavirus has never passed Koch’s Postulates so therefore there is NO pandemic…just a scam-demic.

  13. Chacka says:

    I have no issue with the FDA trying to ensure the home tests are more accurate than not.

  14. Paul says:

    Agencies tend to follow rules established with the best intentions based on what was known at the time. There is always a lag in updating. Those that made mistakes in the past with dire consequences are naturally reluctant to proceed without a high confidence level they are on the right path before updating. Decisions made in haste may be correct but where life and death are on the line there is little room for uncertainty. The specificity of a test that uses PCR is in doubt because the method multiplies what is present. If only one thing is present you may have hit the bull’s eye. The point made by others this is too slow a method for a real time crisis that requires immediate action. Just following rules may have no effect on infection rates of pathogens with unknown or only partially known properties. It is a race to find what works quickly in detection and treatment and any innovation that shows the slightest promise in that direction should be allowed to proceed until downsides are observed. Bureaucratic behavior be damned.

  15. Ada D Galbavy says:

    In FDA’s infinite wisdom, they totally screwed up my bloodwork and cancer treatments. To supposedly, keep me from being exposed to Covid-19 they decided that if Keytruda was safe every 3 wks at 200 units then it could be doubled and given once every 6 weeks… Well thanks for making it so I could possibly be exposed even more times to Covid-19.

    It has been 10 weeks and I still can’t take my Keytruda because my bloodwork results are in the toilet. Thanks FDA for nothing! I have been exposed 5 extra times.

  16. Covington testing should be allowed at home! More lives could be saved!

  17. Julie Gottsponer says:

    Home testing would at least be a start. Put it through!

  18. Gary G. Kohls, MD says:

    In reality the PCR nasal swab coronavirus test – used for allegedly diagnosing Covid-19 – can’t tell the difference between an ordinary benign common cold coronavirus infection (or the simple carrier state for the common cold coronavirus) and the more serious Covid-19.

    The Mainstream Media has gone along with the Big Pharma/CDC-generated Big Lie that every positive PCR test (whether false positive or actual positive) is the same as a “case” of Covid-19, which is ridiculous.

    Therefore EVERY statistic that comes out of the Big Pharma-influenced CDC is based on flawed statistics, whether for death rates or incidence rates. Garbage In, Garbage Out. Please read the entire article, the first half of which is included below. Gary G. Kohls, MD, Duluth, MN
    ______________________________________________________________________________________

    Duty to Warn

    National Security Alert: COVID PCR Tests Scientifically Fraudulent, Causing an Epidemic of False Positives

    By David DeGraw, Torsten Engelbrecht, and Konstantin Demeter – August 05, 2020 (5642 words)

    Theme: Intelligence, Media Disinformation, Science and Medicine

    PCR tests should not be relied upon for accurate results and create a significant percentage of false positives.” – David DeGraw
    “In one of the three scenarios…the Positive Predictive Value for the SARS-CoV-2 RT-PCR test was only 30 percent, which means that 70 percent of the people that tested “positive” are not “positive” at all.” – From the mainstream German medical journal Deutsches Ärzteblatt

    “Detection of viral RNA may not indicate the presence of infectious virus or that 2019-nCoV is the causative agent for clinical symptoms.” – US CDC file on 2019 Novel Coronavirus Diagnostic Panel, March 30, 2020

    “The PCR tests (for Covid-19) are only 30 – 50 per cent accurate.“ — Wang Chen, president of the Chinese Academy of Medical Sciences

    “It has been widely reported that the RT-qPCR [Reverse Transcriptase quantitative PCR] test kits used to detect SARSCoV-2 RNA in human specimens are generating many false positive results and are not sensitive enough to detect some real positive cases.” — Sin Hang Lee of the Milford Molecular Diagnostics Laboratory in a letter to Dr Anthony Fauci and the WHO’s coronavirus response team – March 22, 2020

    “…the CDC and the FDA…concede in their files that the ‘SARS-CoV-2 RT-PCR tests’ are not suitable for SARS-CoV-2 diagnosis.” – The Authors

    “The FDA admits that positive results… do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease.” – The Authors

    “These assays are not intended for use as an aid in the diagnosis of coronavirus infection….(They are) for research use only. Not for use in diagnostic procedures.” – From the PCR test kit distributed by Roche

    “The numbers generated by these RT-PCR tests do not in the least justify frightening people who have been tested “positive” and imposing lockdown measures that plunge countless people into poverty and despair or even drive them to suicide.” – The Authors

    _____________________________________________________________________________

    Preface to the Engelbrecht & Demeter Expose by David DeGraw – August 5, 2020 (824 words)

    Polymerase Chain Reaction (RT-PCR) tests are used worldwide to “diagnose” Sars-Cov-2 infection. An in-depth investigation reveals clear scientific evidence proving that these tests are not accurate and create a statistically significant percentage of false positives. Positive results more likely indicate “ordinary respiratory diseases like the common cold.”

    In fact, American biochemist Kary Mullis, now deceased, who won the Noble Prize in chemistry for creating PCR technology, repeatedly stated throughout his career that it should not be used to test for viruses. This technology is designed to replicate DNA sequences, not test for coronavirus infections.

    Executive Action Required
    President Trump must take immediate action to investigate and hold members of the FDA, CDC and WHO accountable for scientific fraud and Crimes Against the Humanity.
    If he does not take immediate action, he is thereby complicit in what clearly amounts to Crimes Against Humanity, as this report will detail.
    Multiple U.S. Intelligence Community contacts have verified the accuracy of the extensive investigative report, conducted by award-winning journalist Torsten Engelbrecht, featured below. While they do take issue with some of the reports verbiage, they corroborate the main findings: PCR tests should not be relied upon for accurate results and create a significant percentage of false positives.

    We also feature a New York Times report from 2007, entitled, “Faith in Quick Test Leads to Epidemic That Wasn’t,” which also clearly reveals how scientifically inaccurate PCR tests are, featuring many shocking statements from medical experts on the use of these tests, clearly laying out how they result in false positives and lead to dangerous exaggerations and false alarms.

    Note: We are NOT reporting that the coronavirus is a complete hoax. You should take precautions and consult your doctor for best safety practices.

    We are reporting, as the evidence reveals, that the number of COVID-positive results and the number of COVID-related deaths have been significantly exaggerated.
    Based on our findings, the World Health Organization, the Centers for Disease Control and Prevention, and the Food and Drug Administration should not be trusted or relied upon for accurate information, and needs to be immediately investigated and held accountable for Crimes Against Humanity.
    Before reading Engelbrecht’s investigation into the science that proves how fraudulent “COVID-19 testing” is, let’s recap the overall state of what can accurately be defined as an “attack” on us.
    For your family’s sake, please do not instinctively dismiss any of these facts. Please read this entire post before it gets deleted by corrupt censors.

    Fact 1) As thousands of Doctors worldwide have proven, there are several effective treatments for this coronavirus. (source one, two, three, four, five, six)

    Fact 2) The effective treatments have been censored and suppressed for reasons including but not limited to:

    a) They are inexpensive, i.e. Big Pharma can’t profit off of them;
    b) They completely derail the wider-agenda of those interests who are exploiting this virus to implement the most oppressive economic, “health” and surveillance system ever;
    c) There is an FDA Emergency Use Authorization (EUA) law which only allows the mass “vaccination” program to continue if there are no other effective treatments. There is also a EUA “National Security” stipulation that requires a significant percentage of the population to be at risk of death, which is another reason why fraudulent false-positive testing is being used, as you will see below. (source)

    For all of these reasons, the effective treatments have been suppressed; leading to the unnecessary deaths of thousands of people.
    Fact 3) The handling of this virus has resulted in an all-out economic disaster that has destroyed the livelihood and financial security of billions of people worldwide, leading to unprecedented rates of debt, depression, drug abuse, overdoses and suicides. Meanwhile, the CARES Act and global central banking operations in response to this “crisis” have resulted in an unprecedented consolidation of wealth by the world’s richest 0.01%. (source one, two, three, four)

    Fact 4) The lockdown, quarantine and closer of schools, religious services, sports, recreational activities, social events, shopping, food and workplaces, along with social distancing measures and mandatory mask use, in combination with criminally negligent 24/7 mainstream media virus fear propaganda, amounts to psychological torture and abuse on an unprecedented scale, which has torn apart and separated many families, and has done significant damage to the psychological wellbeing of billions of people, particularly young children, worldwide. (source)

    Fact 5) Underfunded and cash-strapped hospitals have been financially incentivized to record as many COVID-related deaths as possible, resulting in a statistically significant number of falsely reported COVID-related deaths. On top of that, hospitals have also been heavily incentivized to put people on ventilators, which has also contributed to thousands of additional unnecessary deaths. (source one, two)

    Now that we have a better understanding of the overall situation, of the Crimes Against Humanity that have been strategically implemented thus far, let’s look at the science that reveals the fraudulent testing process. Here’s is Torsten Engelbrecht’s and Konstantin Demeter’s report:

    ____________________________________________________________________________

    COVID-19 PCR Tests are Scientifically Meaningless

    By Torsten Engelbrecht & Konstantin Demeter – June 27, 2020 (4466 words)

    Though the whole world relies on RT-PCR to “diagnose” Sars-Cov-2 infection, the science is clear: they are not fit for that purpose.

    Lockdowns and hygienic measures around the world are based on numbers of cases and mortality rates created by the SARS-CoV-2 RT-PCR tests used to identify “positive” patients, whereby “positive” is usually equated with “infected.”
    However, when looking closely at the facts, the conclusion is that these PCR tests are meaningless as a diagnostic tool to determine an alleged infection by SARS-CoV-2.
    Unfounded “Test, test, test” Mantra
    At the media briefing on COVID-19 on March 16, 2020, the WHO Director General Dr Tedros Adhanom Ghebreyesus said: “We have a simple message for all countries: test, test, test.”

    The message was spread through headlines around the world, for instance by Reuters and the BBC.
    Still on May 3, the moderator of the Heute Journal — one of the most important news magazines on German television — was passing the mantra of the corona dogma on to his audience with the admonishing words:
    “Test, test, test — that is the credo at the moment, and it is the only way to really understand how much the coronavirus is spreading.”
    This indicates that the belief in the validity of the PCR tests is so strong that it equals a religion that tolerates virtually no contradiction.
    As Walter Lippmann, the two-time Pulitzer Prize winner and perhaps the most influential journalist of the 20th century said: “Where all think alike, no one thinks very much.”
    So to start, it is very remarkable that Kary Mullis himself, the inventor of the Polymerase Chain Reaction (PCR) technology, did not think alike. His invention got him the Nobel prize in chemistry in 1993.
    Unfortunately, Mullis passed away last year at the age of 74, but there is no doubt that the biochemist regarded the PCR as inappropriate to detect a viral infection.

    The reason is that the intended use of the PCR was, and still is, to apply it as a manufacturing technique, being able to replicate DNA sequences millions and billions of times, and not as a diagnostic tool to detect viruses.
    How declaring virus pandemics based on PCR tests can end in disaster was described by Gina Kolata in her 2007 New York Times article, “Faith in Quick Test Leads to Epidemic That Wasn’t.” (full article below) <>

  19. Bob C. says:

    There are no accurate tests for SARS-COV-2. Even a profesionally done PCR test is known to produce up to 30% false positives and negatives, and it will often label the common cold as COVID-19. The guy who invented PCR said it should never be used to diagnose anything, and yet the entire world is relying on it. It’s a shame this nobel prize winner died in October 2019, just before all this started. He would have a lot to say about what’s going on today. All the decisions made over the past 6 months by Presidents, Governors and other leaders have been based on a test that is not accurate. Add to that all of the false causes of death attributed to the corona virus for various reasons, and you have a world that has gone off the rails in terms of any logical response to this virus.

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