A recent article in the Daily Mail carries this very long headline, “Why ARE COVID cases plummeting? New infections have fallen by 45 percent in the U.S. and 30 percent globally in the past three weeks but experts say the vaccine is NOT the main driver because only eight percent of Americans and 13 percent of people worldwide have received their first dose. ”
The story goes on to recount the opinions of various experts as to why cases are dropping. It finally comes to the conclusion that the drop is likely due to a higher number of people who’ve had the virus than official counts suggest and that as many as 90 million people in the U.S. may have already been infected.
But these experts may have missed an important factor that led to this decrease: the test that is used to diagnose the presence of COVID-19 in patients has been changed recently to make it less sensitive.
A Polymerase Chain Reaction or PCR test detects genetic material from the COVID-19 virus. It can find the presence of a virus if you are infected at the time of the test. The PCR test can also detect fragments of the virus even after you are no longer infected. The test swabs are placed into a machine called a thermocycler which uses temperature to denature or separate the DNA of the virus and then replicate it using an enzyme
To amplify a segment of DNA using PCR, the sample is first heated so the DNA denatures, or separates into two pieces of single-stranded DNA. Next, an enzyme called “taq polymerase” synthesizes — builds — two new strands of DNA, using the original strands as templates. This process results in the duplication of the original DNA, with each of the new molecules containing one old and one new strand of DNA. Then each of these strands can be used to create two new copies, and so on, and so forth.
The cycle of denaturing and synthesizing new DNA is repeated as many as 40 times, leading to more than one billion exact copies of the original DNA segment. If you have a full-blown symptomatic case of COVID-19, the thermocycler will pretty quickly detect it among all the other DNA in the test sample because symptomatic cases contain higher viral loads. The fewer cycles it takes to find it, the higher the viral load you have in your system. And that is the problem.
The makers of the thermocycler typically set the machine between 40-45 cycles by default. It is up to the users in the lab to lower it to a cycle threshold (Ct) that gives more accurate results. But a thermocycler set at the factory at 40 cycles is going to keep running the test until it is not finding the active and replicating live virus but the debris that remains of it AFTER you’ve recovered from exposure and can’t pass it on to anyone.
Imagine a large bowl of multi-colored M&Ms candies, with red M&Ms representing a piece of COVID-19 DNA. Each cycle is akin to taking a scoop from the bowl. If the bowl had a large percentage of red M&Ms, the likelihood of the first few scoops (or cycles) to include one or more red M&Ms would be higher, and therefore indicative of an active infection. If the bowl had a very small number of red M&Ms, it would take more scoops (cycles) to retrieve a red one. The higher the number of scoops, the higher the likelihood that you’d retrieve a red candy at some point.
With this type of test, there is no agreed-upon standard by the federal or state governments as to what the maximum cycle threshold of a given machine should be. The CDC says it should be 33, Dr. Fauci says it should be 35. In the absence of any clear unified standard, it’s highly likely that the states have simply left their thermocyclers set at the factory default of 40 to 45 cycles. This default setting would lead to a high percentage of positives results, or, in others words, positive test results for patients who have already recovered from the virus and are not able to infect others.
It became apparent even to the WHO that worldwide tests were too sensitive.
In early December 2020, the World Health Organization sent out an advisory that said that the cycle threshold needed to be manually adjusted to prevent the overstating positive COVID-19 test results.
“Users of RT-PCR reagents should read the IFU carefully to determine if manual adjustment of the PCR positivity threshold is necessary to account for any background noise which may lead to a specimen with a high cycle threshold (Ct) value result being interpreted as a positive result,” read the advisory.
This is after nine months of these tests detecting the dead virus in people who have already recovered. The reports of these ‘cases,’ which were conflated with active, contagious carriers, led public health and government officials to grossly overstate the number of COVID cases and set policies about business lockdowns, school closures, quarantines, and mandatory mask orders. Patients who tested positive were never told what the Ct value was for their tests and therefore had no idea in what stage they might be regarding the infection. A low Ct means a full-blown COVID infection with a high viral load; anything above a 33 Ct probably means the test has detected the dead virus after recovery.
In other words, a 33 Ct means more scoops into the bowl of M&Ms to locate a very low number of red ones.
To make matters worse, state or federal health officials did know what the Ct value was in individual test results. The only thing reported is the actual result. To give you an idea of what a Ct value translates to, think on this. A Ct of 12 has 10 million times as much viral genetic material in the sample as one with a Ct value of 35, which was still being reported as a positive for COVID infection.
It really can’t be overstated how much damage to the country and to people’s lives this has done. But states are beginning to take action to quietly correct this major error which may have occurred in their testing regimen. In January, states began lowering the Ct at which a positive for an active COVID infection would be found.
Florida has gone further, now requiring testing facilities to provide the Ct of each test done to the state.
This is not to say that everyone is on board with these changes.
Dr. Fauci has stated publicly that a Ct above 35 is probably detecting the dead, non-transmissible debris of the virus in the sample. Yet, the CDC contradicts him by saying that they do not believe Ct is an accurate measurement of viral load, and therefore there’s no risk of transmission at a Ct of 33-40.
Newly elected President Biden said on January 22 that the virus was surging and that nothing could be done to change the trajectory that we are on regarding new infections and deaths that are expected to reach over 600,000. He also predicted that there will be darker days still ahead in this emergency. Presumably, President Biden was getting the consensus view of scientists at the CDC.
Yet, just a couple of weeks later, CDC is mystified as new infections have dropped by 45 percent in that same time period.
Americans looking to the experts for answers on how to fight the pandemic would be right to ask at this point, “Do any of you have any idea what you’re doing?”
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