The FDA Botched Covid Testing in 2020. Nothing Has Changed Since Then.

01/25/2021Dave Albin

Ah, the covid-19 test results—much maligned by some and worshipped by others! As part of the ongoing covid-19 pandemic, the results of covid-19 tests are repeatedly blasted at us from many places, often with analysis. It is easy to understand why this is the case. News media and information outlets of all types can present the absolute numbers of positive tests and data trends, which are easy to find, and many viewers can seemingly grasp what’s happening and where. And people are concerned about the spread of a novel virus and what it might do to them, their families, and their communities. In short, this is information that people demand. As such, they will get it.

It’s important to understand the basics of the two main types of tests being used to detect the virus. First, a PCR test is used to amplify and detect the presence of a DNA segment that is highly specific to covid-19. Second, an antibody test is used to detect the presence of an antigen (often a specific protein) that is present on the outside of a pathogen like covid-19. Both of these tests take biological processes and manipulate them to detect the presence of something specific—in these cases, markers of covid-19. There’s nothing magical or sacred about what’s happening. Anyone with the supplies and proper training can run these tests and report findings. And, like with any analytical procedure, there are restrictions on what can be detected. False positives and false negatives are possible, detection levels have limits, and sampling technique affects the results. All of these can be examined to better define the accuracy of the results.

And, yet, as concerns about covid-19 were rapidly increasing, many people were without this vital information that they wanted. Why was this? In the US, the Food and Drug Administration has authority over all medical testing, and in times of emergency, what is known as emergency authorized use, or EUA, can be granted so that labs around the country can begin testing. However, due to bureaucracy and red tape, the FDA took weeks, rather than days, to grant EUAs (another way of saying that it was slow to give up a little authority) so that testing could begin. It was even reported that the FDA and state authorities instructed one lab to halt their plans of repurposing existing tests for covid-19 testing. (By the way, history is already being rewritten, so it seems.) Some labs reported being ready to give results, with validated testing protocols in hand, but being forced to wait due to the FDA’s slow response time. Thus, critical time was lost; people were flying blind for weeks as fear increased.

The purpose of the EUA process, and FDA oversight, is clear enough—to weed out poorly performing test providers. But there are big problems here: First, this assumes that FDA employees are experts at everything they are regulating, which cannot be the case. Second, if the oversight is faulty or results in unnecessary delays (as was the case with covid-19 testing), nothing happens. The FDA still has the same authority now that it had in 2019. Third, oversight with lab testing is largely meaningless without having regulators (assuming they understand the scientific basis for what’s being done) observing what’s happening in the lab. Reviewing documents or protocols is largely ceremonial if the “experts” don’t have a clear understanding of the procedures and, more importantly, if they are not in the labs with the technicians performing the tests. Who knows if the tests are being administered properly, or if, following employee turnover, a new staff member is poorly trained and improperly gives the tests? This last scenario cannot ever be tracked and controlled by regulators.

These regulatory challenges would have been much better addressed with private sector testing facilities competing for customers. In order for a testing lab to be chosen by eager customers, its results have to be meaningful—those that do not provide this will not be in business for long. 

In addition, a private testing system would have allowed quicker data sharing sooner (and the use of various platforms) and for testing to be conducted in a way that pleases customers. In some areas, the reporting would have been different, but ultimately it would have had to satisfy customers. And with something like a global pandemic, broader sharing of information would likely have been welcomed at first and might have changed later—the market could have decided over time. Competing evidence would even have served as an important quality control.

It’s a good bet that an approach like the one outlined here would have mediated the effects of the covid-19 pandemic. There’s no question (with the benefit of hindsight) that covid-19, and the response to it, was going to cause difficulty and suffering for many people. Lives have been lost, businesses and services derailed, and trust eroded. But, with the right information in hand, decision-making would have been improved. Trouble areas and practices could have been avoided. Personal risk could have been assessed more accurately. We could have understood what was happening sooner and worked to get through the covid-19 pandemic more quickly. Instead, we’re left with the same stagnant, bloated system that’s slow to respond—troubling because other pathogens are sure to arise in the future. We can’t afford to stumble in the darkness again.Author:

Contact Dave Albin

Dave Albin conducts process development research and provides technical support for a food equipment manufacturer in Iowa.

Avatar

jpmrwb • 2 days ago

The PCR is a major problem but there are other problems that add to the total fiasco. I have read so many articles on virology that I feel I should get a degree in virology (But I digress)

The first thing one should look at, what is the gold standard for determining you have a virus and the one that is causing the disease. This has not been done. The virus has not been properly isolated and purified so we don’t even know what it is. It could be something other than a virus. And 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 of four of the principal, early 2020 papers claiming discovery of a new coronavirus concede they had no proof that the origin of the virus genome was viral-like particles or cellular debris, pure or impure, or particles of any kind. In other words, the existence of SARS-CoV-2 RNA is based on faith, not fact.

In the product descriptions of the RT-qPCR tests for SARS-COV-2 it says they are “qualitative” tests, contrary to the fact that the “q” in “qPCR” stands for “quantitative.” And if these tests are not “quantitative” tests, they don’t show how many viral particles are in the body. (Viral Load)

The CDC, the WHO, the FDA or the RKI may assert that the tests can measure the so-called “viral load,” i.e. how many viral particles are in the body. “But this has never been proven. That is an enormous scandal,”
Another critical problem is that many PCR tests have a “cycle quantification” (Cq) value of over 35, and some, including the FDA protocol has a CQ of 45.
The Cq value specifies how many cycles of DNA replication are required to detect a real signal from biological samples.
“Cq values higher than 40 are suspect because of the implied low efficiency and generally should not be reported,” as it says in the MIQE guidelines.
MIQE stands for “Minimum Information for Publication of Quantitative Real-Time PCR Experiments”, a set of guidelines that describe the minimum information necessary for evaluating publications on Real-Time PCR, also called quantitative PCR, or qPCR.

The inventor himself, Kary Mullis, agreed, when he stated:

If you have to go more than 40 cycles to amplify a single-copy gene “there is something seriously wrong with your PCR.”

Last but certainly not least.
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.

And a “positive” result may have serious consequences for the patients as well, because then all non-viral factors are excluded from the diagnosis and the patients are treated with highly toxic drugs and invasive intubations. Especially for elderly people and patients with pre-existing conditions such a treatment can be fatal.
This information was taken from: https://off-guardian.org/20… There is much more information on this farce.

TexasHeavenTexas • 2 days ago • editedThe PCR inventor, Kerry Mullis, died just before all this covid hysteria started and was unable to fulfill his dream: To debate Anthony Fauci because he thought Fauci was an a$$ h0l3. I can’t help but wonder what sort of censoring Mullis would have received in this milieu.So, here’s a rare opportunity that I will use the ‘someone I know personally told me so’ refrain. I could very well be lying as it’s just hearsay, but I will share it nonetheless.My cousin is indeed a microbiologist. I had a discussion with her back when all the ‘cases’ were skyrocketing in March/April. In that conversation she stated to me that any result from a PCR cycle threshold above 30 should be thrown out. When I learned more about the sensitivity/specificity of these tests, I contacted her again and told her that cycle thresholds were going up to 45. She could not fathom that and vehemently insisted that it could not be true because, and I quote, “Only an idiot would do that.”The CDC, WHO, FDA, NAIAD,ABC,XYZ, blah blah blah allowed/authorized/encouraged/condoned any cycle threshold, even up to 45. And labs took off testing like crazy ( some labs had nearly 100% positives) everywhere. ‘Cases’ skyrocketed. Cases were now redefined.So, would this have happened with ‘good test producers’? Yes, it would have. We could have had the BEST PCR test ever devised, but with bad specificity and sensitivity parameters, the test produced by the ‘good producers’ would have done the same $h!t. The goal was to ramp up cases. End of story.I don’t even know how we can compare any aspect of this to the free market. If there were a free market, none of this would be occurring. You have a higher risk of dying of ANYTHING in 12 months, than you have of dying of covid-19. Who is going to invest in that?

Avatar

Really?? • a day ago

I recently took a class from a PhD microbiologist who currently works at the NSF dealing with COVID-19 issues. In her class, she explained that there are four different types of molecular tests for the RNA associated with COVID. They generally involve “reverse transcription” of a sample that converts RNA to DNA and then a process to make copies of the DNA for testing. The tests differ in the time it takes to process the sample and the temperature for the testing. The test acronyms are RT-PCR (the most common using a nasal swab), RPA, LAMP and CRISPR.

The presence of these tests don’t tell individuals what can be done if they test positive. For example, if a test shows that you are positive, the recommendation is to isolate oneself, just like many of us are already doing without any testing. Maybe, if one tests positive, a regimine of infusing monoclonal antibodies or Remdesivir COULD be administered. But, in the world we live in where vaccine distribution is utterly opaque and essentially random (try getting a vaccine if you don’t believe me) and hospital space is non existent, I suspect that getting pro-active treatment in the form of infusions will be limited to giverment big wigs and not available to the general public.

Avatar

Ektor • 4 hours ago

No testing method for Covid has never undergone long term trials to even see if it is adequate and can provide meaningful results. These tests were allowed on an emergency basis only and are highly suspect concerning their ability to provide a true result. Furthermore, both injectable gene therapy solutions were created using algorithms designed to replicate what a possible Covid particle or germ might be like. No actual virus protein has been discovered or was used to create these gene therapy protocols. Pfizer and Moderna have admitted to such.

The gene therapies are all guesswork. Thus, how can we have testing for a virus/protein that has yet to be isolated and identified and then purified to give exact results? It’s a total sham all the way around. The fake pandemic was created and suddenly we had any number of solutions and forthcoming vaccines (all fake, mind you) before this thing was isolated and really understood by the medical community. We still have, after a year of Covid, flip-flopping by Fauci, the CDC, FDA and WHO on all aspects of this fake pandemic and fake virus.

Avatar

Sensory Order • 2 days ago

It’s important to understand the basics of the two main types of tests being used to detect the virus. First, a PCR test is used to amplify and detect the presence of a DNA segment that is highly specific to covid-19.

RNA.

Anyone with the supplies and proper training can run these tests and report findings.

It wasn’t true initially. Many PCR tests for Covid-19 were being developed and refined, but when they were ready, the bureaucrats moved too slowly. Dave’s link to The Atlantic in the article is a good reminder of March frustration for who haven’t already read it. Another good review is here.

These regulatory challenges would have been much better addressed with private sector testing facilities competing for customers. In order for a testing lab to be chosen by eager customers, its results have to be meaningful—those that do not provide this will not be in business for long.

Like Theranos? But we didn’t have a decade to sort it out. Like the $20M of commercial test kits purchased by Britain that didn’t work? Even in the United States, a lot of early commercial antibody testing (not PCR) was worthless.

The important thing to remember is that when we did have the tools to fight on the defensive, we laid them down and surrendered.

Avatar

Dave Albin Sensory Order • 2 days ago

PCR tests amplify DNA. It’s true that some PCR testing protocols begin with RNA, but it is converted to DNA before the PCR step. This is RT-PCR. There’s also real-time PCR which amplifies a DNA segment in real-time. It gets confusing because this can also be called RT-PCR.
It’s also true that there was a time lag as PCR testing became developed. However, it’s likely that a “good enough” PCR protocol was developed early on when people were screaming for some information. You could quickly develop a PCR test that will pick up a few coronoviruses, including COVID-19, and use this approach to determine hot spots. This is really what people wanted – just some idea of where things were bad. Not perfection. But, as I wrote in the article, with this and more advanced testing, the FDA stood in the way at one of the worst possible times.

Avatar

Sensory Order Dave Albin • a day ago

PCR tests amplify DNA. It’s true that some PCR testing protocols begin with RNA, but it is converted to DNA before the PCR step. This is RT-PCR.

Yes. Reverse transcriptase first. You wrote:

First, a PCR test is used to amplify and detect the presence of a DNA segment that is highly specific to covid-19.

There are people in the comments section laboring under the misapprehension that human DNA could create a false positive Covid-19 RT-PCR test. (Hi Eiji.)

It’s also true that there was a time lag as PCR testing became developed. However, it’s likely that a “good enough” PCR protocol was developed early on when people were screaming for some information.

Agreed. The German protocol published in January, for example.

You could quickly develop a PCR test that will pick up a few coronoviruses, including COVID-19, and use this approach to determine hot spots.

Not a good strategy. We already had RT-PCR for “a few coronaviruses”. Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63 and Coronavirus OC43 were on viral respiratory panels. They were worthless and caused the kind of confusion in January and February expected in people that don’t understand how RT-PCR testing works.

This is really what people wanted – just some idea of where things were bad. Not perfection. But, as I wrote in the article, with this and more advanced testing, the FDA stood in the way at one of the worst possible times.

The FDA, CDC and federal government did not act with the speed required by the situation. The Red Dawn email chain documents the disbelief of physicians and scientists who realized what was happening. The article linked in my first post notes that problems continued as late as March.

It is not true that “nothing has changed” since this scandal. It was, however, a terrible start.

♥Thanks for sharing♥

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google photo

You are commenting using your Google account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s