07-21-2021 Lab Alert Changes to CDC RT-PCR for SARS-CoV-2 Testing

CDC Quietly removes EUA for COVID 19 PCR Test; withdraws it as an effective test to diagnose COVID 19 infection

CDC issues Laboratory Alert, notifying clinicians PCR test will be withdrawn as a valid test for detecting SARS-CoV-2 Infection
December 29, 2021

With no mainstream media coverage and little fanfare, the CDC issued a “Laboratory Alert” through “The Laboratory Outreach Communication System”, notifying clinicians administering the COVID 19 PCR test, that it will be withdrawn as a valid test for detecting SARS-CoV-2 effective December 31 of 2021.

woman receiving COVID 19 PCR test

Lab Alert: Changes to CDC RT-PCR for SARS-CoV-2 Testing

“After December 31, 2021, CDC will withdraw the request to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of the CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel, the assay first introduced in February 2020 for detection of SARS-CoV-2 only.” https://www.cdc.gov/csels/dls/locs/2021/07-21-2021-lab-alert-Changes_CDC_RT-PCR_SARS-CoV-2_Testing_1.html

07/21/2021: Lab Alert: Changes to CDC RT-PCR for SARS-CoV-2 Testing – Centers for Disease Control and Prevention

The Laboratory Outreach Communication System (LOCS) is a Division of Laboratory Systems (DLS), part of the Center for Surveillance, Epidemiology, and Laboratory Services (CSELS) of the Centers for Disease Control and Prevention (CDC).

You will be able to see an updated list of currently valid COVID-19 diagnostic methods on the FDA Website.

The document is not long and ends by advising clinicians and doctors to “transition” to a different COVID-19 test known as a “multiplexed method”:

“CDC recommends clinical laboratories and testing sites that have been using the CDC 2019-nCoV RT-PCR assay select and begin their transition to another FDA-authorized COVID-19 test. CDC encourages laboratories to consider adoption of a multiplexed method that can facilitate detection and differentiation of SARS-CoV-2 and influenza viruses.”

07/21/2021: Lab Alert: Changes to CDC RT-PCR for SARS-CoV-2 Testing – Centers for Disease Control and Prevention

You can join the Laboratory Outreach Communication System via e-mail subscription on the tools.cdc.gov web page to keep updated on CDC developments, alerts and news.

Lab Alert: Changes to CDC RT-PCR for SARS-CoV-2 Testing | PDF File

Kary Mullis Inventor of The COVID 19 PCR Test

Dr. Kerry Mullis talks about Inventing PCR Test | Video

Dr. Kerry Mullis talks about Inventing PCR Test | Video

Dr. Kerry Mullis on PCR Test for COVID 19 | Video

“Scientists are doing an awful lot of damage to the world in the name of helping it. I don’t mind attacking my own fraternity because I am ashamed of it.”

Kary Mullis, Inventor of PCR
Dr. Kerry Mullis on PCR Test for COVID 19

John Lauritsen’s 1996 article about Kary Mullis

A 1996 article written by John Lauritsen about Kary Mullis, regarding the “Ebola epidemic” with statements from Kary Mullis; inventor of the PCR test:

“Kary Mullis… is thoroughly convinced that HIV is not the cause of AIDS. With regard to the viral-load tests, which attempt to use PCR for counting viruses, Mullis has stated: ‘Quantitative PCR is an oxymoron.’ PCR is intended to identify substances qualitatively, but by its very nature is unsuited for estimating numbers. Although there is a common misimpression that the viral-load tests actually count the number of viruses in the blood, these tests cannot detect free, infectious viruses at all; they can only detect proteins that are believed, in some cases wrongly, to be unique to HIV. The tests can detect genetic sequences of viruses, but not viruses themselves.

John Lauritsen’s 1996 article about Kary Mullis biochemist, and nobel prize winner for invention of PCR test; HAS PROVINCETOWN BECOME PROTEASE TOWN?

This is the just of what we want to take from this article…In other words it’s saying that the PCR test can detect genetic sequences of viruses, but does not actually detect viruses, and can’t cant possible detect viral load

The story comes during an “Ebola epidemic” which Kary Mullis; inventor of the PCR test, thinks utilized the PCR test to create false diagnosis of Ebola Infection and an artificial epidemic.

Quantitative PCR is an oxymoron.

Kary Mullis

Essentially what Dr. Mullis is saying here is that the PCR test can not be utilized to measure how much virus is present in a person’s body. Therefore, the CDC’s gold standard for testing Ebola patients; the PCR test, in fact says nothing about whether patients are sick or will become sick. It says nothing about why some patients do become sick…It also points out other issues with the PCR test:

“errors in carrying out the highly sensitive procedure; lab contamination of the sample taken from the patient; choice of a sample that is not a virus at all, or is the wrong virus.”

ohn Lauritsen’s 1996 article about Kary Mullis biochemist, and nobel prize winner for invention of PCR test; HAS PROVINCETOWN BECOME PROTEASE TOWN?

We also know from statements by Kary Mullis that with enough cycles in a PCR test, and you could find nearly any virus, including Ebola and COVID-19 in the body…

There is an alternative source with a brief excerpt of John Lauritsen’s article about Kary Mullis, see Frontiers in Public Health, 23 September, 2014, “Questioning the HIV-AIDS hypothesis: 30 years of dissent,” by Patricia Goodson. (See also this.)

Other Resources on flaws of PCR Test for COVID-19 Testing

WHO Information Notice for IVD Users Dec 2020 – Version 1

Who sent out an “Information Notice” titled Nucleic acid testing (NAT) technologies that use polymerase chain reaction (PCR) for detection of SARS-CoV-2 to inform clinicians administering the PCR test for detection of SARS-CoV-2, of an “elevated risk for false SARS-CoV-2 results”:

“WHO has received user feedback on an elevated risk for false SARS-CoV-2 results when testing specimens using RT-PCR reagents on open systems.”

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

The notice goes on to state that a SARS-CoV-2 diagnosis, which requires a “high cycle threshold (high ct value)” is likely to be a false positive; the rational being someone with a high “viral load” would require less cycles to detect the virus (low ct value):

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. The design principle of RT-PCR means that for patients with high levels of circulating virus (viral load), relatively few cycles will be needed to detect virus and so the Ct value will be low. Conversely, when specimens return a high Ct value, it means that many cycles were required to detect virus. In some circumstances, the distinction between background noise and actual presence of the target virus is difficult to ascertain.

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

As a result they recommend that the PCR test be manually adjusted to ensure a SARS-CoV-2 positive test which uses a high cycle threshold to detect the virus, is not simply producing a falst positive “due to background noise”:

Thus, the IFU will state how to interpret specimens at or near the limit for PCR positivity. In some cases, the IFU will state that the cut-off should be manually adjusted to ensure that specimens with high Ct values are not incorrectly assigned SARS-CoV-2 detected due to background noise.

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

A full copy of the page printed into a PDF file is available below.

WHO Information Notice for IVD Users May 2020 Version 2

The who later modified the “Nucleic acid testing (NAT) technologies that use polymerase chain reaction (PCR) for detection of SARS-CoV-2” document in a Version 2; omitting some of the original information (see pdf printout of web page below – also available on wayback machine):

Dr. Eric Neptune on PCR Test for COVID 19

Dr. Mike Yeadon – former Pfizer vice president claims nearly all PCR tests are false positives

External peer review of the RTPCR test to detect SARS-CoV-2 reveals 10 major scientific flaws at the molecular and methodological level: consequences for false positive results | Article

“a tremendous number of very serious design flaws were found by us, which make the PCR test completely unsuitable as a diagnostic tool to identify the SARS-CoV-2 virus.”

External peer review of the RTPCR test to detect SARS-CoV-2 reveals 10 major scientific flaws at the molecular and methodological level: consequences for false positive results

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