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WHO Finally Issues New, Stricter Guidelines on Use of PCR Tests for COVID-19
Warns against tests being too sensitive and advises a second test, with symptoms, to confirm a positive case
By: David Deschesne
January 27, 2021
In response to governments relying too heavily on “positive” PCR tests for COVID-19, the World Health Organization (WHO) released new guidance on the use of the tests with more stringent use of those tests recommended. The stricter guidelines, which were intended to cut down on the number of false - or non-infectious - positive COVID-19 cases, were coincidentally released to the public on January 20, 2021 - inauguration day in the U.S.
Throughout the COVID-19 pandemic, governments relied on a single RT-PCR test to determine if a person is infected and contagious with the COVID-19 coronavirus, or not. The extreme sensitivity of these tests at detecting virus particles and RNA makes them unsuitable for diagnostic purposes because of the number of people who may show the presence of a viral particle even if it is a non-infectious, inactive viral fragment.
The new guidelines published by the WHO, entitled, “WHO Information Notice for IVD Users 2020/05”1 advise health care providers to be more selective about declaring a positive case.
The document states, “careful interpretation of weak positive results is needed. The cycle threshold (Ct) needed to detect the virus is inversely proportional to the patient’s viral load.” This means that the less virus a person has in them, the higher the cycle threshold will need to be in order to detect viral fragments. Most virologists agree a cycle threshold of greater than 35 cycles is a non-infectious case and should be considered negative. Maine, like many other states is using a PCR test kit for its COVID-19 tests that has an excessively high cycle threshold of 45, rendering most of the “positive” test results meaningless.
Globally, and especially in the U.S., these excessively sensitive PCR tests are then artificially inflating the number of purported COVID-19 deaths since anyone who dies with a positive PCR test for the virus is arbitrarily considered a “COVID-19 death” even if the virus had nothing to do with their death at all.
The WHO guidance further states, “Where test results do not correspond with the clinical presentation, a new specimen should be taken and retested using the same or different NAT technology.” What this means is simply getting a positive COVID-19 PCR test should not be enough to declare a person “positive” if they are presenting no symptoms of the disease and that a second test should be performed with a new sample from that person.
The WHO guidance also reminds health care providers that “Most PCR assays are indicated as an aid for diagnosis, therefore, health care providers must consider any result in combination with timing of sampling, specimen type, assay specifics, clinical observations, patient history, confirmed status of any contacts, and epidemiological information.”
In other words, WHO is advising to use the PCR tests for COVID-19 in the same way those tests have been used for decades in identifying common flu strains in people showing up at hospitals with symptoms of the flu. Mass testing of COVID-19 in mostly healthy people is now being discouraged and the focus is on testing only those who appear to have symptoms - a return to the standard operating procedure on PCR tests for normal, seasonal flu.
In December, the WHO also issued guidance on the sensitivity of PCR tests because so many “positive” cases were showing up in people that were not showing symptoms, or were infectious. That document, published on December 14, 2020 stated, “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 value result being interpreted as a positive result...In some circumstances, the distribution between background noise and actual presence of the target virus is difficult to ascertain.”2
Tightening up the criteria for determining a “positive” COVID-19 case appears to be conveniently and coincidentally timed to coincide with the inauguration of Joe Biden as “president” in the U.S. It has been suggested that this policy change may be used in the U.S. to make falling case numbers appear to be the result of Biden’s COVID-19 policies rather than a move to finally using the PCR tests properly for the first time in the so-called “COVID-19 pandemic.”
Notes:
1. https://www.who.int/news/item/20-01-2021-who-information-notice-for-ivd-users-2020-05
2. https://www.who.int/news/item/14-12-2020-who-information-notice-for-ivd-users (this link may no longer be active, but a pdf of the report is available from WFFJ-TV upon request)