CDC: PCR Covid-19 'Gold Standard' Test to Be Discontinued, Replaced With Equally Flawed Testing

Updated: Aug 12

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The Covid-19 testing program is an unmitigated disaster with severe flaws documented by government public health organization's own data. RT PCR tests are a research, not a diagnostic tool, and inherently unable to diagnosis Sars CoV2.


The Story:


Review of PCR testing flaws and public health organization data documenting severe errors with tests


The main test for detection of Sars CoV'-2, RT PCR will be discontinued on 12/31/2021. Non-specific and equally unsuitable antigen testing with potential to produce up to 100% false positive results when used in low incident populations & non-specific antibody tests will continued to be used utilized as alternative methods. A new and equally useless PCR with the same limitations and problems as original RT PCR testing will be utilized, this one ostensibly documented to differentiate between Sars CoV-2 & the flu.


Below, a review of severe and extensively documented flaws with PCR testing, and evidence public health agencies failed to correct for errors despite full knowledge of the problems. Additionally, recently established testing protocol changes to create entirely different standards for counting Covid-19 cases for vaccinated versus unvaccinated indicate deliberate manipulation of case number by the CDC.


The purported 'gold standard' test is being abandoned by the FDA per the CDC:

* Media 'fact checks' are appearing to falsely inform public on RT PCR issue and PINNED to top of search engines for terms related to this subject. Full response and evidence debunking false information promoted in piece may be viewed HERE:


New RT PCR Fl SC2 Covid-19 Flu & CovidTest Just As Unsuitable for Virus Detection as Original Test


Documentation of SEVERE PCR testing flaws:


The PCR testing has been assailed by experts, as a method for determination of Covid-19 infection, The Emergency Use testing was approved one day after release of the Corman Drostan paper on which the science of the testing is based. Peer review by the International Consortium of Science by 22 top experts determined ten serious flaws with the scientific methodology of the testing, and deemed RT PCR testing useless for detection of Sars CoV2, the virus attributed to cause symptoms of Covid-19.

The panel filed a motion to retract the paper due to the errors to the Eurosurveillance Editorial Board (European health regulatory agency)


Full retraction request letter and signatures of peer review panel may be viewed HERE:


Retraction request letter to Eurosurveillance editorial board


The use of non-specific and unsuitable testing methods for determination of Covid-19 infection has severe and far reaching implications to all aspects of Covid-19 science from diagnostics to research study reliability.


A review of these issues may be viewed HERE:


All Covid-19 Vaccine Trial And Research Data Fatally Compromised Through Severely Flawed Testing


International courts have ruled against Covid-19 government mandates based on RT PCR testing due severe testing inaccuracies and design flaws including the Vienna administrative court of Austria:


"Following the Portuguese, German and Dutch rulings, now the Austrian court has ruled that PCR tests are not suitable for COVID-19 diagnosis and that lockdowns has no legal or scientific basis.


In particular, the criteria and definitions used to determine the number of corona infections are being massively questioned. It is expressly pointed out that, even according to the World Health Organization (which took a u-turn only after Biden took office),


“a PCR test is not suitable for diagnosis and therefore does not in itself say anything about the disease or infection of a person”.


“However, the Minister of Health uses a completely different, much broader case definition for Covid-19 diagnosis, which cannot be used to justify the prohibition of a meeting.”


Government public health organization data and public health official statements on PCR testing also document significant problems with the use of RT PCR and testing protocol error recommendations by the FDA for detection of Sars CoV-2..


The FDA ordered PCR testing to be run at Cycle Threshold levels that result in false positives by default of the setting:


PCR tests work by amplifying test sample material which ostensibly detects for RNA material attributed to Sars CoV2.


However, the CDC Emergency Use Guidelines for RT PCR testing for Sars CoV'2 state document PCR test was developed without any Sars CoV2 virus isolate , instead test designers utilizing existing cell & cancer cell lines.


"The analytical sensitivity of the rRT-PCR assays contained in the CDC 2019 Novel Coronavirus (2019- nCoV) Real-Time RT-PCR Diagnostic Panel were determined in Limit of Detection studies.


"Since no quantified virus isolates of the 2019-nCoV were available for CDC use at the time the test was developed and this study conducted, assays designed for detection of the 2019-nCoV RNA were tested with characterized stocks of in vitro transcribed full length RNA (N gene; GenBank accession: MN908947.2) of known titer (RNA copies/µL) spiked into a diluent consisting of a suspension of human A549 cells and viral transport medium (VTM) to mimic clinical specimen".


Further information on this subject may be viewed HERE:


On Virus Isolation Method, Non-Specific Covid-19 Tests, New Drug Treatments for Covid-19 Infections


PCR tests are set at cycle threshold rates which determine how many cycles the test sample will run through to amplify it. Every cycle run reduces the amount of available sample material, and if too many cycle are instituted, there will be nothing left but dead, non-infectious material.


The FDA ordered the RT PCR tests to be run at Cycle Threshold levels (CT rates) up to 40 cycles with some US labs running the tests up to 45.


The level at which a test becomes 'over-amplified' and detection of dead, non infectious material (and produce a false positive result) has been stated to be as low as 24 with a recent study to assess for viable infectious material finding no live material above this setting:


Predicting Infectious Severe Acute Respiratory Syndrome Coronavirus 2 From Diagnostic Samples


"There was no growth in samples with a Ct > 24"


The FDA setting cycle rates at levels which have found to result in MAJORITY false positives due to the agency's recommendation error can not be simply dismissed as a oversight or minor mistake.


In a New York Times story , highlighting studies correcting for the CT rate error, one scientific expert expressed shock at the error:


"Any test with a cycle threshold above 35 is too sensitive, agreed Juliet Morrison, a virologist at the University of California, Riverside. “I’m shocked that people would think that 40 could represent a positive,” she said.


A more reasonable cutoff would be 30 to 35, she added. Dr. Mina said he would set the figure at 30, or even less. Those changes would mean the amount of genetic material in a patient’s sample would have to be 100-fold to 1,000-fold that of the current standard for the test to return a positive result — at least, one worth acting on".


Dr Anthony Fauci admitted in a interview on July 16, 2020 that a cycle threshold rate over 35 is 'dead nucleotides period and disingenuously told the interviewer that care providers had the CT rate included in lab report to correct for a error that should have resulted in immediate lowering of CT settings for PCR tests:


Interview with Dr Fauci may be viewed HERE. Press play in the video box, the relevant segment will play:


https://principia-scientific.com/dr-fauci-admits-covid-test-picks-up-harmless-dead-virus/


According to the New York Times article, CT number was not being included in the lab reports:


"This number of amplification cycles needed to find the virus, called the cycle threshold, is never included in the results sent to doctors and coronavirus patients, although it could tell them how infectious the patients are.


In three sets of testing data that include cycle thresholds, compiled by officials in Massachusetts, New York and Nevada, up to 90 percent of people testing positive carried barely any virus, a review by The Times found." (Note, 'barely any virus' is a erroneous interpretation of a false positive test RT PCR test result. Sars CoV2 RT PCR tests are non-specific and detect dead non infectious material. Sars CoV2 presence can not be definitively determined due to non-specificity of test)


Unfortunately, the Times in covering this story did not follow up to ensure the testing issue was ever corrected, and pushed for the use of equally flawed and unreliable rapid antigen tests for the tests 'over-sensitivity' issue covered in the article The Times also failed to question the FDA on why the agency set CT rates at levels agency experts experts should be fully aware would result in false positive errors, and did not ask why the cycle recommendation rates were not lowered , a very simple action to correct for a severe error.


Some media organizations did report on the PCR testing story, but there was no change to how these news organization (including the Times) reported case numbers, infection rates, and morbidity numbers and no follow up to ensure FDA took action to correct for the problem.


If the Times or other media outlets had followed up on this story and reviewed FDA and WHO statements for Antigen & PCR testing in the coming months, the journalists would have discovered no action was taken to provide the Cycle Rate number to care providers until December 14, 2020, the date in which the World Health Organization released a statement which warned of the false positive issue described above and FINALLY instructed labs to provide the CT number in the lab reports:


The WHO has removed much of the 2020 Covid-19 data on the organization's website, but the original WHO statement release is archived and documented HERE:


Principa Scientifica article on the statement may be found HERE


The WHO statement admits use of test in low incident populations will create false positives:


WHO Statement - December 14, 2020


"As with any diagnostic procedure, the positive and negative predictive values for the product in a given testing population are important to note. As the positivity rate for SARS-CoV-2 decreases, the positive predictive value also decreases. 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 positivity rate decreases, irrespective of the assay specificity.


Due to the probability of errors with the tests, the WHO organization advised that symptom presentation should be included in ascertainment of diagnosis"


This statement documents false positive tests will occur at higher rates in populations with low infections rates. It also confirms that a single flawed diagnostic test study should not be the criteria for ascertaining infection with Sars CoV2. Most important, it advises SYMPTOM PRESENTATION be included in diagnosis due to probability of error. This indicates probable testing error and not 'asymptomatic infection as the underlying cause for individual presenting with no symptoms and a positive PCR test result.


Statement continues:

"Therefore, healthcare providers are encouraged to take into consideration testing results along with clinical signs and symptoms, confirmed status of any contacts, etc".


Here the agency is stating that symptom presentation should be included in a formulating diagnosis, a foundational premise of medical diagnosis that was lost in determining infection status through a sole diagnostic test.


The statement continues:

"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"


This statement technically explains the Cycle Threshold setting issue as described above. It should be noted that the WHO is acknowledging the problem but fails to institute the most basic and logical correction for the error, namely lowering the CT rate so that over amplification will not occur. This statement provides evidence the agency is fully aware of the testing issue but does not take true action to correct for it (simply lower the rate to levels that will not over-amplify the material)


The statement continues:

"In some circumstances, the distinction between background noise and actual presence of the target virus is difficult to ascertain. 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.


This statement admits that 'background noise' (i.e material other than attributed Sars CoV2 material may be detected by the test). This is another admission of non specificity of the test (i.e. the test picks up other materials)


On page 38 of the CDC Emergency Use Guidelines, the CDC states a positive PCR test does NOT equate to symptom presentation or contagion due to Sars CoV2:


The statement continues:


"Manufacturers regularly review the design of their product, including labelling and IFU based on customer feedback. In the early phases of the COVID-19 pandemic, in vitro diagnostics (IVDs) were rapidly developed, validated and verified, and then rolled out. Therefore, it is not unexpected that IVDs may require refinement based on user feedback after their introduction at scale. Users should verify the version of the IFU with each consignment they receive to see if any changes have been made to the IFU.

Advice on action to be taken by 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. Consider any positive result (SARS-CoV-2 detected) or negative results (SARS-CoV-2 not detected) in combination with specimen type, clinical observations, patient history, and epidemiological information.

  5. Provide the Ct value in the report to the requesting healthcare provider.

Transmission of this WHO Information Notice for Users:

Please disseminate this notice to all those who need to be aware within your organization or to any organization where the potentially affected product has been deployed and used".


The above directs inclusion of the Cycle Threshold rate in lab report, a directive which finally allowed correction for a error that found to be create up to 90% false positive results.


The guidance however gives NO instruction for how health care providers should interpret the data and apply it to test interpretation, And, most importantly, it did not CHANGE the recommendation to prevent the problem from occurring entirely.


The above statement also fundamentally changes how providers should formulate diagnosis. A positive result on a PCR test does NOT equate to infection with Sars CoV2 as shown by the evidence above.


State agencies continue to report positive test results as infections despite public health organization own evidence & WHO statement documenting this standard is not scientifically accurate for ascertainment of Sars CoV2 infection.


The date of this WHO statement must be noted. December 14, 2020 as it coincides with the emergency, investigative use approval of the Pfizer Covid-19 vaccine:


https://www.webmd.com/vaccines/covid-19-vaccine/news/20201213/cdc-gives-pfizers-covid-19-vaccine-final-approval


The issue of high cycle threshold rate and error had been publicly exposed to be resulting in majority false positives Sars CoV2 PCR tests since the summer of 2020. The agency did not change the CT setting to correct for error and timed the change to provide CT number in lab reports on the EXACT SAME DAY as the first Covid-19 vaccine emergency approval was given.


The change to provide data to care providers to (partially) correct for a error creating up to 90% false positive test results would obviously result in decreased case infections reports of Sars CoV2 infection (Covid-19 'cases).


Dramatic case drops ensued:


January:


"In the span of two weeks, states in the U.S. West pushed down coronavirus case averages by 43%, outstripping the decline in other regions, which all have seen numbers retreat from peaks this month.


Almost every state in the West reported cases falling or flat Tuesday, and every region in the country has seen its seven-day average drop at least 20% since Jan. 12, according to data from the Covid Tracking Project"


Testing and not infection rates have been driving the numbers.


The entire basis for social distancing, masking, lockdowns, school closures is based on the theory of asymptomatic transmission of Sars CoV2 unsubstantiated (and disproven) by evidence and easily explained by the use of testing that creates majority false positives by testing methodology flaws and recommendation errors.


When up to 90% of individuals are receiving false positives with PCR test, (and no test result valid for diagnosis due to nine other severe errors document by expert peer review research), the explanation for the phenomenon is NOT silent infection.


The explanation for majority of individuals testing positive but expressing no symptoms of Covid-19 is these individuals are simply NOT ill. The WHO statement confirms that a positive diagnosis should include symptom presentation for attribution of a positive diagnosis for Sars CoV2 infection.


Further refutation of asymptomatic theory may be reviewed here:


Asymptomatic Presentation of Positive Covid-19 Test Result Due to Faulty Tests, Testing Methods & Protocols


Dr Sam Bailey: Great Summary on Asymptomatic Transmission & Why It's False


April/May 2021:


Different Reporting Standards for Unvaccinated Versus Vaccinated Established:


Evidence highly suggests the testing protocols are being deliberately manipulated as evidenced by the recent CDC change to reporting that establishes entirely different standards of case reporting for Covid-19 infections for vaccinated versus non vaccinated individuals:


As of May 1, 2021, the CDC announced it will only monitor (i.e. report) Covid-19 cases in vaccinated if the individual is vaccinated or experiences a associated death:


"As of May 1, 2021, CDC transitioned from monitoring all reported vaccine breakthrough cases to focus on identifying and investigating only hospitalized or fatal cases due to any cause. This shift will help maximize the quality of the data collected on cases of greatest clinical and public health importance".


Previous data on all vaccine breakthrough cases reported to CDC from January–April 2021 are available.


Additionally, in April, the CDC issued new guidance to laboratories recommending reducing the RT-PCR CT value to 28 cycles — but only for those fully vaccinated individuals being tested for COVID.


Because CDC would like to characterize the SARS-CoV-2 lineages responsible for COVID-19 vaccine breakthrough cases, including variants:

  • Report sequence results from a state public health laboratory, commercial reference laboratory, or academic laboratory by entering the PANGO lineage and GenBank or GISAID accession number into the COVID-19 vaccine breakthrough REDCap database.

  • If SARS-CoV-2 sequencing will not be performed locally and an acceptable clinical respiratory specimen is available, provide instructions for the testing laboratory to send the residual respiratory specimen to CDC.

  • For cases with a known RT-PCR cycle threshold (Ct) value, submit only specimens with Ct value ≤28 to CDC for sequencing. (Sequencing is not feasible with higher Ct values.)


The CDC & FDA continues to enact testing recommendation and reporting standards that will continue to result in false positive results by high CT settings for non-vaccinated individuals, at the same time, the agencies are changing test standards that will dramatically decrease Covid-19 case reports in vaccinated individuals. And, if vaccinated individuals still receive a positive test, the case will not be recorded in state report numbers unless the 'case' is attributed to an individual who is hospitalized or dies. (It should be noted that a positive test with hospitalization will be reported by the state as a Covid-19 hospitalization regardless of whether the hospitalization is due to Covid-19 attributed infection, just as a Covid-19 morbidity will be attributed to Covid-19 with a positive testing result, regardless if individual died from another cause.


This is blatant manipulation of testing protocols that will drastically skew data and allow public health officials to make claims around vaccine efficacy due to lower rates in vaccinated on completely unscientific and unethical reporting manipulations. It indicates the CDC is engaging in fraud.


A word on 'variants'


The CDC is advancing a false narrative on variant outbreaks which has been based on the same severely flawed testing used for diagnosis of Sars CoV2. Please watch the video interview by Attorney Reiner Fuellmich with David Martin included at the end of the article. Mr Martin is an international patent attorney investigating the orgin of sequencing, he has documented the Sars CoV2 sequences are based on existing cell line with patent dates going back up to 20 years. He has concluded there is no delta variant.


Update: FDA website documents no virus isolate of Sars CoV2 & use of DIFFERENT source materials by the companies that developed the test:


The FDA documents on the organization's Sars CoV'2 Reference Panel Comparative Data website page, the following admission:


"During the early months of the Coronavirus Disease 2019 (COVID-19) pandemic, clinical specimens were not readily available to developers of IVDs to detect SARS-CoV-2".


Translation, the testing was developed without Sars CoV-2 virus isolate instead developed on 'contrived samples'


Statement continues:

"Therefore, the FDA authorized IVDs based on available data from contrived samples generated from a range of SARS-CoV-2 material sources (for example, gene specific RNA, synthetic RNA, or whole genome viral RNA) for analytical and clinical performance evaluation".


(i.e. this testing is NOT based on a new 'novel' coronavirus but EXISTING synthetic material)


While validation using these contrived specimens provided a measure of confidence in test performance at the beginning of the pandemic, it is not feasible to precisely compare the performance of various tests that used contrived specimens because each test validated performance using samples derived from different gene specific, synthetic, or genomic nucleic acid sources.


Here they are admitting they had NO standardized model for test development and utilized different gene materials for each test.


In sum, the above statement admits the PCR testing is non specific to Sars CoV2 and developed for detection of DIFFERENT source material NONE of which included the virus the test is stated to detect!!!!


CDC documentation on virus isolation and sequencing may be reviewed HERE

To summarize:

Billions of dollars have been spent on unreliable PCR tests which have created corrupted and highly flawed data unsuitable for informing individual diagnosis and public health policy.


The CDC and FDA website documents PCR testing was created without isolate of Sars CoV2 was utilized for developing the PCR tests and the testing was based on non-standardized materials with each testing companies utilizing different source material. The testing is NON-SPECIFIC to the Sars CoV2, and a positive result does not equate to symptom presentation or contagion due to the presence of the virus.


The public health organization own documentation provide clear evidence that testing recommendation error have generated majority false positive tests.


For over a year, the majority of the mainstream media news sources have turned a blind eye to severe problems with testing, either not reporting on the testing problems at all or failing to provide their audience with any context of the implications of this data.


News outlets fully aware of test problems (NYT) continue to report state generated Covid-19 case and morbidity rates on known flawed testing methods and attribution standards without caveat.


All Covid-19 measures implemented on the basis of this testing must be immediately suspended.


All vaccine trial data has been fatally corrupted through use of PCR testing unsuitable for detection of Sars CoV2 for diagnostic purpose and end point outcome measurement.


The media should immediately stop reporting stories through the perspective of political opinion and undergo an objective review of fact. The failure of journalists to do so have contributed to serious public health harm by enabling public health officials to present hugely inflated Covid-19 case numbers to rationalize completely unnecessary public health directives which have been extensive documented to have inflicted extreme individual and public health harms.


And, ANY effort to detract from the examination of substance of the evidence through the demonization of the messenger must immediately cease. The smear campaign that the media has enacted against those seeking to provide factual review of evidence on behalf of their employers will be remembered as one of the worst betrayals of journalistic ethics in world history. The facts are in plain sight. Review them.


Public health 'experts' who tout Covid-19 policies and health directives based on fatally corrupted data and manipulated testing featured by these new organizations are acting against medical, scientific, ethical and licensing standards in asserting claims based on faulty data and/or lack of evidence entirely (example, there is no mid or long term data what so ever on ANY Covid-19 emergency investigative use vaccine, so there is NO way to make a valid claim of safety around these products).


FDA Emergency, INVESTIGATIVE Use Approval Letters may be viewed HERE:


Pfizer

Moderna

Johnson & Johnson (Janssen)


For review of documentation of equally severe testing issues with antigen and antibody test, please go HERE and HERE


A must watch interview with Reiner Fuellmich documenting the time line for patent of virus sequencing attributed to Sars CoV-2 this evidence shatters the entire Covid-19 narrative and proves deliberate fraud:

And, a brilliant video providing more credible documentation on issue of virus isolation problems presented in a clear and understandable way - must watch for anyone ready to look at the Covid-19 narrative with an open mind:

Dr Roger Hodkinson, Royal College Pathologist Exposes PCR Test Fraud:



Update: Doctors are becoming aware of this issue and informing patients of the problems with test: August 8, 2021


PCR Test in Not Valid


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