Nucleic Acid Testing

The nucleic acid testing (NAT) technologies that use polymerase chain reaction (PCR) tests have been getting some attention again. This is the most common kind of test used for detection of COVID-19.

And this caught my eye… The World Health Organization (WHO) published a notice on January 20 concerning the interpretation of PCR results, cautioning those who use PCR tests.

This is a surprise. The Centers for Disease Control (CDC), the Food and Drug Administration (FDA), and the broader medical community have incorrectly used the PCR tests as if they were a diagnostic tool that can provide a simple “positive” or “negative” as a result. Ironically, that’s not what the test was designed for.

The WHO’s announcement noted, “The cycle threshold (Ct) needed to detect virus is inversely proportional to the patient’s viral load.” This is accurate.

It went on to state, “As disease prevalence decreases, the risk of false positive increases.” Very true.

And it was surprisingly candid in stating, “Most PCR assays are indicated as an aid for diagnosis.” In other words, they’re not intended to provide definitive positive or negative diagnoses.

The cycle threshold setting is at the center of what I consider to be an epic scandal. It is why we have seen a very high percentage of false positives.

Each cycle used in a PCR test amplifies the genetic material analyzed in the test. The higher the setting, the higher the sensitivity.

If the sensitivity is set too high, it can pick up fragments of a dead virus. In other words, it’s not something that causes symptoms or is infectious. In the U.S., cycle thresholds are set at 40. And in Europe they’re between 40 and 45.

Michael Mina, an epidemiologist at the Harvard T.H. Chan School of Public Health, offered his own insight into the very high sensitivity and corresponding low viral loads. He stated, “It’s really irresponsible, I think, to forgo the recognition that this is a quantitative issue.” He went on to say, “We’re using that for clinical diagnostics, for public health, for policy decision-making.”

Juliet Morrison, a virologist at the University of California-Riverside, believes that even setting the cycle threshold to 35 is too sensitive. She went on to say, “I’m shocked that people would think that 40 could represent a positive.”

And it’s not just them.

When interviewed on this topic, even Dr. Anthony Fauci stated, “If you perform the test at a cycle threshold of 35 or more, the chances of it being replication-confident [accurate] are miniscule. You almost never can culture the virus [detect a true positive result] from a 37 threshold cycle… even 36.”

What’s the right cycle threshold setting that would identify a live virus capable of spreading? Mina believes that number is 30 or less. Morrison says somewhere between 30 and 35.

Yet throughout this entire pandemic, the industry has been using 40. This has resulted in anywhere between 60% and 90% false positives.

This is why we have an epidemic of cases rather than people who are actually symptomatic and capable of spreading COVID-19. Cycle threshold settings of 40 will identify viral fragments from months ago.

In other words, you already had it but didn’t know it. It doesn’t mean you’re infectious, but you are testing positive.

The case numbers are almost meaningless as a result. And the mortality numbers, for the same exact reasons, are also grossly overstated.

It really makes me sick to my stomach thinking about all of the lives that have been destroyed due to the economic lockdowns and the lifelong harm to school-aged children caused by so many terrible policy decisions. And so many of these decisions are based on inaccurate data.

But I have a solution. I know a way to address the media-induced fear and panic around COVID-19 cases.

Simply set the cycle threshold to a scientifically proven setting of 30. That would identify viral loads with the possibility of replicating. That way, we can identify those who should quarantine and those who can live freely.

What will happen when we do that? Both the number of cases and the number of claimed COVID-19 mortalities would collapse overnight.

And we’d have a radically different and more accurate view of the pandemic that could shape solid policies meant to deal with its effects.