March 01, 2021

One Hour After Biden Inauguration, WHO Admits High-Cycle PCR Tests Produce COVID False Positives

Jan 21, 2021 | , ,

The WHO Finally Updates Its COVID-19 Testing Policy… One Hour After Biden’s Inauguration

In August of last year, The New York Times published an article stating that as many as 90% of COVID-19 tests in three states were not indicative of active illness. In other words, they were picking up viral debris incapable of causing infection or being transmitted because the cycle threshold (Ct) of the PCR testing amplified the sample too many times.

Labs in the United States were using a Ct of 37-40. Epidemiologists interviewed at the time said a Ct of around 30 was probably more appropriate. This means the CDC’s COVID-19 test standards for the PCR test would pick up an excessive number of false positives. The Times report noted that the CDC’s own data suggested the PCR did not detect live virus over a Ct of 33. The reporter also noted that clinicians were not receiving the Ct value as part of the test results.

Yet a PCR test instruction document from the CDC that had been revised five times as of July 13, 2020, specified testing and interpretation of the test using a Ct of 40. On September 28, 2020, a study published in the journal Clinical Infectious Diseases from Jaafar et al. had asserted, based on patient labs and clinical data involving nearly 4,000 patients, that a Ct of 30 was appropriate for making public policy. An update to the CDC instructions for PCR testing from December 1, 2020, still uses a Ct of 40.

Shortly before the New York Times article was published, the CDC revised its COVID-19 test recommendations, saying that only symptomatic patients should be tested. The media went insane, and Dr. Fauci went all over television saying he was not part of the decision to change the testing standards:

“I am concerned about the interpretation of these recommendations and worried it will give people the incorrect assumption that asymptomatic spread is not of great concern. In fact it is.”

Fauci had spoken, and the guidelines went back to testing everyone, all the time, with an oversensitive test. The idea that asymptomatic spread was a concern as of August was just one of many lies Dr. Fauci told. At the beginning of the pandemic in late January, he said:

The one thing historically that people need to realize is that even if there is some asymptomatic transmission, in all the history of respiratory borne viruses of any type, asymptomatic transmission has never been the driver of outbreaks. The driver of outbreaks is always a symptomatic person. Even if there is a rare asymptomatic person that might transmit, an epidemic is not driven by asymptomatic carriers.

There is not a single study or meta-analysis that differs from Fauci’s original assessment.

Today, within an hour of Joe Biden being inaugurated and signing an executive order mandating masks on all federal property, the WHO sent out a notice to lab professionals using the PCR test. It said:

WHO guidance Diagnostic testing for SARS-CoV-2 states that careful interpretation of weak positive results is needed (1). The cycle threshold (Ct) needed to detect virus is inversely proportional to the patient’s viral load. 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.

This translates to “in the absence of symptoms, a high Ct value means you are highly unlikely to become ill or get anyone else sick in the absence of very recent exposure to an infected person.” Dr. Fauci knew this in July when he said that tests with a Ct above 35 were likely picking up viral debris or dead virus. Even at a Ct of 35, the incidence of virus samples that could replicate is very low, according to Jaafar et al. The only state I know that requires reporting the Ct with every test is Florida, which started this policy in December.

The WHO went on, stating:

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 short, a positive PCR test in the absence of symptoms means nothing at a Ct of higher than 30, according to the experts interviewed by the New York Times and according to Jaafar et al. Yet positive tests is the number CNN loves flashing on the screen. If the percentage found by the Times in August holds, there have been approximately 2.43 million actual cases to date, not 24.3 million. There is also no way to calculate the deaths from COVID-19 rather than deaths with some dead viral debris in the nostrils.

FROM THE WHO:

WHO Information Notice for IVD Users 2020/05

Nucleic acid testing (NAT) technologies that use polymerase chain reaction (PCR) for detection of SARS-CoV-2

20 January 2021

Medical product alert
Geneva
Reading time: 1 min (370 words)

Product type: Nucleic acid testing (NAT) technologies that use polymerase chain reaction (PCR) for detection of SARS-CoV-2

Date: 13 January 2021

WHO-identifier: 2020/5, version 2

Target audience: laboratory professionals and users of IVDs.

Purpose of this notice: clarify information previously provided by WHO. This notice supersedes WHO Information Notice for In Vitro Diagnostic Medical Device (IVD) Users 2020/05 version 1, issued 14 December 2020.

Description of the problem: WHO requests users to follow the instructions for use (IFU) when interpreting results for specimens tested using PCR methodology.

Users of IVDs must read and follow the IFU carefully to determine if manual adjustment of the PCR positivity threshold is recommended by the manufacturer.

WHO guidance Diagnostic testing for SARS-CoV-2 states that careful interpretation of weak positive results is needed (1). The cycle threshold (Ct) needed to detect virus is inversely proportional to the patient’s viral load. 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.

WHO reminds IVD users that disease prevalence alters the predictive value of test results; as disease prevalence decreases, the risk of false positive increases (2). This means that the probability that a person who has a positive result (SARS-CoV-2 detected) is truly infected with SARS-CoV-2 decreases as prevalence decreases, irrespective of the claimed specificity.

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.

Actions to be taken by IVD users:

  1. Please read carefully the IFU in its entirety.
  2. Contact your local representative if there is any aspect of the IFU that is unclear to you.
  3. Check the IFU for each incoming consignment to detect any changes to the IFU.
  4. Provide the Ct value in the report to the requesting health care provider.

Contact person for further information:

Anita SANDS, Regulation and Prequalification, World Health Organization, e-mail: rapidalert@who.int

References:

1. Diagnostic testing for SARS-CoV-2. Geneva: World Health Organization; 2020, WHO reference number WHO/2019-nCoV/laboratory/2020.6.

2. Altman DG, Bland JM. Diagnostic tests 2: Predictive values. BMJ. 1994 Jul 9;309(6947):102. doi: 10.1136/bmj.309.6947.102.

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