World Health Organization PCR Testing Guidance

On January 20th, 2021, while a new administration was sworn into office, the World Health Organization (WHO) published a notice on their website:

This notice acknowledges a problem, makes a request, and provides WHO guidance and recommendations on testing for and detecting SARS-CoV-2, which will ultimately impact the way COVID is diagnosed.

Let’s break it down.

Target audience”: From the above screen capture we can see that this notice is specifically for diagnostic medical device users (the medical professionals and/or technicians who are performing PCR tests).

What is the PCR test?

The PCR test is a Nucleic Acid Test (NAT), also known as a Nucleic Acid Amplification Test (NAAT), which takes a sample from a patient and amplifies (makes copies of) the genetic material from in the sample in order to detect the virus. (“Nucleic acid” refers to the genetic material. DNA stands for deoxyribonucleic acid.)

The number of times the sample is amplified is referred to as the number of cycles. The Cycle threshold (Ct) is the number of cycles performed (or number of times the sample needed to be amplified) in order to detect viral genetic material.

From the CDC website:

Side note: The “RT” in “RT-PCR” stands for “reverse transcriptase”. In the case of COVID, they are aiming to detect for RNA rather than DNA, and therefore a reverse transcriptase PCR test is used. The RNA is reverse transcribed into DNA prior to amplification.

But let’s go back to the WHO notice:

Description of the problem”: The WHO is suggesting here, that those performing PCR tests are not following the instructions for use when interpreting results from PCR tests.

The notice then states that those who are performing PCR tests “must read and follow” the instructions for use by the manufacturer of the test they are using, to determine if manual adjustment of the positivity (cycle) threshold is recommended. Why? Because, if you perform enough cycles, the sample will eventually return a positive result. (More explanation below.)

In other words: Rather than the PCR test returning a simple and conclusive “positive” or “negative” result, the results require interpretation in order to determine “positive or negative”, and it depends on how many cycles were required to detect viral genetic material.

Additionally, there are various manufacturers of PCR tests, each of which have their own instructions for use of the test and how to interpret results. The cycle threshold for PCR tests also differs from one manufacturer to another.

Why is this a problem?

First, when there are multiple tests and also different cycle thresholds being used or recommended, there’s no standard for what constitutes a positive or negative result. A positive result for a patient’s sample tested by a lab in New York might return a negative result from a lab in Texas – both of which use PCR tests. You cannot compare tests which use different cycle thresholds. (Yet they’re all being lumped together for an overall “case count”.)

Second, the greater the number of times a sample is amplified in order to detect viral genetic material (higher Cycle threshold, Ct), the greater the risk of returning a false positive. Meaning, the test can identify genetic material that returns a positive result but doesn’t actually indicate the presence of the virus. (It’s a positive test that should have been negative.)

At this point, it might be helpful to take note that the WHO originally published a notice regarding PCR testing in mid-December (“version 1”) where they state that they have “received user feedback on an elevated risk for false SARS-CoV-2 results when testing specimens using RT-PCR”. This notice describes why higher cycle thresholds can return false positives, but has been since removed from the WHO website:

This first version of the notice was published to “ensure users of [PCR] technologies are aware of certain aspects of the instructions for use (IFU) for all products.”

Alternatively, the more recently published notice from January 20th reiterates that the issue of potential false positives is still a problem, states that users of PCR technologies “must read and follow” instructions, and then refers to previously published WHO guidance for testing for SARS-CoV-2: Diagnostic testing for SARS-CoV-2

In the published guidance document, the WHO presents the following flow chart for diagnosis of SARS-CoV-2 infection:

The very first requirement is “Patient meets the clinical criteria for COVID-19.” Note the asterisk, which refers to a footnote at the bottom of the page: “Clinical management of COVID-19 (Interim Guidance).”

In this Interim Guidance document, it describes the signs and symptoms of the clinical presentation of COVID:

Note that the clinical presentation includes symptoms. The WHO is stating that diagnosis for a positive case starts with an individual who is presenting with actual symptoms of COVID-19.

Therefore, if we were to use the WHO diagnostic criteria for determining positive cases, would asymptomatic cases be included in the overall case count? Where is the recommendation for asymptomatic persons to get tested unless knowingly exposed to an infected, symptomatic individual?

Regardless, we do know that an unknown number of individuals who are completely asymptomatic and have not been known to be exposed to COVID-positive individuals do take tests, and some do so regularly to rule out infection. How many of these individuals or tests are included amongst the overall case count? Fauci himself has stated that 40-45% of COVID cases are asymptomatic.

Moving on, down the original diagnostic flow chart. The next step (or blue rectangle) is “NATT**”.

This is again, referring to the PCR test. The double asterisk sends you to a footnote referring to another guidance document: “Interim guidance on antigen-detection in diagnosis of SARS-CoV-2 infection using rapid immunoassay.”

In this document, it states:

“A useful assessment is the sensitivity of the test in patients with a rRT-PCR cycle threshold (Ct) below a specific value (e.g. 28 or 30), because the virus is expected to be abundant in respiratory samples when the test is in this range, and test sensitivity correspondingly high (exceeding 90% in some published and unpublished studies).” [Emphasis mine.]

In other words, at a cycle threshold of 28 or 30, the ability of the PCR test to correctly identify infection is high. Above this cycle threshold, you start to get more and more false positives. (Which inflates the case count.)

The risk of false positives from high cycle thresholds was detailed in the following New York Times article (surprisingly enough):

To reiterate what was stated in the screen captures from the article above, most PCR tests have cycle thresholds at 40 cycles (some at 37).

A report written by 22 different authors, which includes doctors, experts, and PhDs in molecular genetics, pharmacology, biochemistry, microbiology, immunology, environmental chemistry, toxicology and more, addresses the problem of the number of cycles being used to detect virus in patient samples:

Therefore: When a patient’s sample needed to be amplified at 35 cycles in order to test positive, this “positive test”, 97 times out of 100, is actually negative. It has a 97% chance of being a false positive.

And yet, most PCR tests have cycle thresholds set at 37 or 40, which means there’s an even greater chance a positive test is actually negative.

Imagine how many cases would be eliminated from the count, simply by reducing the number of times patient samples are amplified. Again, WHO guidance states that 28 or 30 cycles is a useful assessment because at that cycle threshold the PCR test is much more accurate.

Yet here we are: Governments are mandating masks, social distancing, and enforcing lockdowns, based on massive numbers of positive tests (and associated deaths attributed to “COVID”) and a large percentage of them are (1) asymptomatic and (2) if they are symptomatic, are likely false (where did the flu go?).

Conveniently, the WHO published the original notice on the risk of false positive PCR tests shortly after the vaccine began to be rolled out, the second week of December. The second notice was published on Inauguration Day.

Now that the US has rejoined the World Health Organization and Fauci has been appointed to represent the US on the WHO’s executive committee, will the CDC adopt these recommendations and pass on similar guidance?

If it does, these changes will have a profound impact on the number of cases we are seeing on a daily, weekly, and monthly basis. The case count will no longer be inflated based on using high cycle thresholds for PCR tests.

In the end, the artificial drop in case count due to this change in diagnostic testing and criteria will be used as evidence that the vaccine is effective.

Therefore, don’t be surprised if and when you start seeing news reports that the vaccine is working. This is exactly what they did with polio.