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5.2 Why Corona Virus PCR Tests are Not Accurate

Given the revolving door between the CDC and corrupt drug companies, why should any of us believe anything the CDC says about anything?

The FDA stands for the Food and Drug Administration. Fifty years ago, my Organic Chemistry professor at Washington State University said that he had quit working for the FDA because it was so corrupt that he could not morally stand to work their any more. He warned us students that the FDA was completely owned by the drug companies and we could not trust anything the FDA told us either about Food or about Drugs. He spent the entire year teaching us about how various organic chemicals – made by drug manufacturers and approved by the FDA - contributed to cancer inside of human cells. I got an A in that course and I have been extremely skeptical of claims made by drug companies and by the FDA ever since.

The following FDA web page lists 8 different methods for testing for the presence of the corona virus: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#coronavirus2019

All of these tests on the FDA web page involve a process called PCR which stands for Polymerase Chain Reaction. As noted earlier, media reports refer to the PCR method as the gold standard in viral testing. Here is an example of the glowing praise for this method: “PCR is the gold-standard testing platform for viruses because it’s highly sensitive — it can detect even a tiny amount of virus in a patient sample and is less likely to incorrectly have a negative result.”

Sadly the above statement is not true. PCR viral tests are known to be so insensitive that they are not able to make an accurate determination until several days after a person has been infected. It is common for a person to test negative when they first come into the hospital and continue to be tested negative for several days before there is enough virus in their system to get a positive result.

People need to be told the truth about PCR. You can get a negative result and still have Corona virus. You can also get a positive result and not have the Corona virus!

There are huge problems when laboratory tests incorrectly tell people they are free of the corona virus. Stories in several countries suggest people are having up to six negative results before finally being diagnosed. https://www.bbc.com/news/health-51491763

The biggest problem is that since the corona virus does not have any noticeable symptoms in the majority of infected victims, if a person is told they do not have the corona virus, when they actually do have it, they can go around and infect many more people with the virus.

Another problem is that because the PCR test is not accurate, officials in the epicenter of the epidemic, Hubei province, China, started counting people with symptoms (presumptive Corona virus) rather than using the tests for final confirmation. As a result, nearly 15,000 new “presumptive” corona virus cases were reported on a single day - a quarter of all cases in the epidemic at the time.

The underlying problem with PCR is that it can pick up viral genetic material only if there’s a lot of it floating around. And early in an infection, before someone starts to feel really sick, there’s often not enough genetic material (RNA) to be picked up by the test.

The PCR test may be accurate for people who look really sick. But using it as a screening tool for asymptomatic people is almost worse than using no test at all. A negative test may simply mean that an infection has not developed enough to be detected by the test.

There is also the difficulty of collecting samples. Detection is confirmed by PCR of genes from blood or sputum secretions. These samples are taken from the back of the throat.

Unfortunately, the back of the throat may not have enough of the virus to be picked up in a PCR test even if the patient is already very sick. PCR tests done on throat swab samples taken at the first visit have been shown to be only about 30% to 60% accurate.

There is also the problem of transporting the samples to a qualified PCR laboratory for examination and the time it takes to obtain a result. Here in Washington state, there is a PCR lab at the University of Washington (and likely many more PCR labs elsewhere in the state since this technology is not rocket science). But at least initially, the US CDC required that all PCR samples be shipped to the CDC lab on the East Coast. Why they made this requirement is very difficult to understand because if anything, the results coming out of the University of Washington PCR lab would be more accurate than anything coming from the CDC lab.

To make matters even worse, we now know that the US CDC does not appear to be capable of even doing the test right in the first place. From the very beginning of the CDC PCR testing, there have been huge errors made by the CDC.

02

 

Why the CDC Corona Virus PCR Test failed Verification Tests
Starting on February 5, 2020, the CDC (Centers for Disease Control in the US) rolled out its own PCR tests to all 50 US states after it obtained Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA). CDC packaged PCR primers, along with their associated fluorescent probes, into kits that could each be used to process between 700 and 800 samples. There were 200 kits made – meaning even if they worked, they could only be used to test 200 times 700 people or 140,000 people in a nation of 330 million people. The kits were sent to 115 state and local public health labs qualified to run the test (some health departments got two tests – meaning they could only test 700 to 1400 people in their state).

https://www.cdc.gov/media/releases/2020/p0206-coronavirus-diagnostic-test-kits.html

As soon as the test kits arrived in the state laboratories, scientists there set about verifying the tests accuracy before giving the tests to the public. Verification involved running known samples of the Corona virus through the test to make sure the PCR test picked up the Corona virus when it should, and did not erroneously count harmless, virus-free samples.

But immediately, within days, a number of those state and local county labs ran into issues. On some test kits, what should have been a negative result came back as a positive result. On other samples, what should have been positive results came back as negative or inconclusive results.

On February 12, the CDC held a press briefing phone call in which the CDC admitted that the problem was the result of a faulty reagent (meaning one or more chemicals in the PCR primer had a significant flaw that rendered the results to be meaningless).

Below is a partial transcript of this February 12 phone call with reporters in which the CDC was forced to admit that there was a big problem with some of their PCR test kits:

https://www.cdc.gov/media/releases/2020/t0212-cdc-telebriefing-transcript.html

Reporter Question: Can you say more about what kinds of problems the state labs encountered in validating the tests and why you need to send new reagents?

CDC Answer: In terms of the test problems, it gets a little weedy, but I can give you a little more detail.  When a state gets the test kits, they have to verify that it works. 

And when some states were doing this, we received feedback that they weren’t — that it wasn’t working as expected, specifically some public health labs at states were getting inconclusive results. We think that maybe one of the reagents wasn’t performing consistently, so it’s a long story to say that we think that the issue at the states can be explained by one reagent that isn’t performing as it should consistently and that’s why we are re-manufacturing that reagent.

My comment on the CDC PCR Reagent Fiasco
I have a minor in chemistry and have studied PCR. The idea that a PCR reagent sent from the CDC would not work tells me that quality control at the CDC must be pretty bad. PCR reagents are not that complex and they should work. The fact that the CDC shipped tests with bad reagents is a really big red flag that there is something very wrong at the CDC.

Why weren’t these reagents tested at the CDC before being sent to the states?

Why weren’t the reagents tested by the source suppliers before being sent to the CDC?

Why is the CDC even recommending a Corona virus test that has so many false negatives and false positives?

Why are they posting data on “confirmed corona virus victims” on their website when they know that the data they are posting is extremely inaccurate?

Why did it take a random question from a reporter on a phone call to finally drag the truth out of the CDC?

Given the revolving door between the CDC and corrupt drug companies, why should any of us believe anything the CDC says about anything?

What’s Next?
Now that you have a better idea of why the PCR “Gold Standard” test is virtually worthless, let’s look at some alternative corona virus tests that are now being used.