Updated: Dec 12, 2021
*There are serious and credible evidence based concerns around the entire Covid-19 narrative. Evidence of testing development errors and protocol errors come directly from test manufacturer and government public health organization own data.
Researchers on this blog have flagged serious test development issues and protocol recommendation errors for Sars CoV-2 (virus attributed to cause Covid-19 infection) testing. Serious, evidence based concerns around proper scientific protocols around correct Sars CoV2 virus isolation and uncorrected testing problems require objective review of fact. Media and health officials are deflecting legitimate criticism of Covid-19 testing and isolation procedures by responding to concerns by labeling any who question compromised testing development and virus isolation procedures as 'conspiracy theorists' and 'anti-science' or framing criticism as 'right wing'. It is long past time for a non-partisan review of evidence and open discussion outside of worn tactics of smear. New organizations who continue to engage in denial of serious review will only further diminish already tenuous credibility, and risk destroying mainstream news credibility for a generation to come. Attacking the messenger is the worst tactic of response to objective scientific review. The scientific method demands full review of pertinent evidence.
In a recent blog research review, it came to light that New York State was utilizing unsuitable and inaccurate Wadsworth antibody testing for utilization of establishing baseline Covid-19 case infection rates for the state of New York. The follow issues were discovered with the testing including
-test was developed without Sars CoV2 standard material, as the foundation for test development instead utilizing Biotin-streptavidin technology which has a FDA warning for false positive testing with biotin supplementation, no warning statement included on NY state fact sheet about false positive risk
-test detects multiple other infectious organisms, test is non specific to Sars Cov2
-test has a specificity rate that will create up to 100% false positives when used in the very populations employed most often to study, low incident rate populations and people with suspected respiratory infections
Full review of issue and all source links for above information may be reviewed here:
Of central concern is this disclosure found in this FDA Emergency Use Summary for Wadsworth testing:
'There is no standard reference SARS-CoV-2 antigen material available; accordingly, absolute analytical sensitivity cannot be calculated'.
In Sum, the Wadsworth model for antibody testing was not developed with the material necessary to detect Sars CoV2 virus isolate and this statement is a confession that accuracy rates can not be truly determined.
The testing New York is using to ascertain baseline Covid-19 cases was developed, not with the viral isolate, but rather utilizes Biotin Streptavidin technology that is non-specific to Sars CoV-2 and detects other infectious material.
The standard New York state is utilizing is useless for baseline testing of Sars CoV2 infection rates in New York state due to errors documented in the FDA use own guidelines. Calls for inquiry to follow up with the New York State Health Department went unreturned.
The issue of testing being developed without proper virus isolate due to lack of availability is not specific to the Wadsorth antibody test. All testing was developed without Sars CoV2 viral isolate:
"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. Samples were extracted using the QIAGEN EZ1 Advanced XL instrument and EZ1 DSP Virus Kit (Cat# 62724) and manually with the QIAGEN DSP Viral RNA Mini Kit (Cat# 61904). Real-Time RT-PCR assays were performed using the Thermo Fisher Scientific TaqPath™ 1-Step RT-qPCR Master Mix, CG (Cat# A15299) on the Applied Biosystems™ 7500 Fast Dx RealTime PCR Instrument according to the CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel instructions for use.
The disclosure shows the test was not developed with use of Sars Cov-2 viral material but rather developed with in stock (already available & transcribed ) RNA spiked with (i.e. not isolated, material added) A549 (cancer cells) and viral transport medium.
In sum, the test was NOT developed for detection of specific Sars CoV2 viral sample isolate for specific detection of virus, but developed with a combination of already available and transcribed RNA with added human A549 (cancer cells) and viral transport medium.
What is missing from the equation is actual Sars CoV-2 sample isolate material which is necessary for proper test and vaccine research development....
Definition of A549 cells: A549 cells are adenocarcinomichumanalveolarbasalepithelialcells, and constitute a cell line that was first developed in 1972 by D. J. Giard, et al. through the removal and culturing of cancerous lung tissue in the explanted tumor of a 58-year-old caucasian male.
Chromosome 8 is one of the 23 pairs of chromosomes in humans. People normally have two copies of this chromosome. Chromosome 8 spans about 145 million base pairs (the building material of DNA) and represents between 4.5 and 5.0% of the total DNA in cells.
"Fact checkers" who seek to debunk claims around the significance of the use of RNA mimicking Chromosome 8 for PCR testing, do not deny that the test development utilized RNA sequencing matching Chromosome 8 for test development, but rather (erroneously) state that this would mean all PCR tests would result in detection and false positive result
However, PCR have been been developed to detect this RNA material when individual are stressed (stressed cells release the RNA material) at very low levels, so the tests would not pick up material the majority of the time (stress from illness, psychological stress may result in the release of RNA material from cells). The mechanism for release of this material is Geoome Toxic Stress: qRT-PCR to detect RNA present at low levels (takarabio.com)
Takarabio has developed RT PCR tests for Sars CoV-2 detection.
Further, the CDC Emergency Use guidelines state specifically that a positive test result with RT PCR Emergency Use only testing does not equate to being either symptomatic or contagious due to Sars CoV-2:
• Detection of viral RNA may not indicate the presence of infectious virus or that 2019-nCoV is the causative agent for clinical symptoms.
• The performance of this test has not been established for monitoring treatment of 2019-nCoV infection.
• The performance of this test has not been established for screening of blood or blood products for the presence of 2019-nCoV.
• This test cannot rule out diseases caused by other bacterial or viral pathogens.
Additionally, it is now extensively documented that majority of positive tests are effective false positives resulting from FDA recommendations to run cycle amplification rates at levels that over-amplify testing sample material and pick up dead and non-infectious material by default of test setting, a full discussion and source links for this issue may be found HERE.
RT PCR testing launched without peer review of science for the testing. This peer review occurred on November 27, 2021:
Austria just ruled against the use of RT PCR testing for detection of Sars CoV-2 due to the accuracy and test development issues documented above.
First isolation case study for Sars CoV2 was based on non-human subject according to
Antigen testing is equally non-specific and unsuitable for detection of Sars CoV2 with the FDA including this disclosure in its blanket template for Antigen test developers:
"Because SARS-CoV-2 neutralizing antibody assays are not standardized, and the performance characteristics of each SARS-CoV-2 neutralizing antibody test is uniquely established, results from different SARS-CoV-2 neutralizing antibody assays cannot be compared.”
Assay: A substance to be so analyzed.
This means that each test developer is utilizing a unique substance for development with no standard assay. The antigen test developers are using unique assays for development of the testing, not standardized isolate from Sars CoV2 viral sample material.
Further, the template states a positive test is not definitive for Sars CoV2, and recommends secondary testing for confirmation, due to non-specificity and 'ability of test to pick up antigen from other infectious material. The full antigen FDA test template may be downloaded for review HERE.
Additionally, states have run Sars CoV2 antigen testing against protocols issued by the FDA warning of high rates of false positive results in use of low incidence population, up to 100%.
In sum, the standard of testing the United States has adopted for establishing Covid-19 health directives and quarantine policies is based on testing developed without Sars CoV-2 sample material, non specific to Sars CoV-2, and documents in the CDC own Emergency Use guidelines, does not constitute a definitive positive diagnosis for Covid-19 infection due to lack of detection of specific viral sample material.
It is on this testing individuals have been mandated to distance, mask, and quarantine.
On Virus Isolation Protocols:
It is a serious red flag that Sars CoV2 testing was not developed around a standardized assay of Sars CoV2 virus isolate sample material, but non-standardized assays resulting in tests non-specific for diagnosis of Sars CoV2.
Why does the FDA & CDC not possess virus isolate for use in standardized testing for accurate detection and diagnosis of Sars CoV2 infection?
Due to the questions of origin of Sars CoV2, fluctuating time lines for introduction of Sars CoV2 into the population, and no available standardized viral material available for development of accurate testing and vaccine development, some independent researchers have been inquiring into whether Sars CoV-2 underwent proper isolation sequencing.
Given the above information, it is entirely relevant to independently inquire into the research to ensure correct method and sequencing occurred for a new 'novel' coronavirus. There is absolutely nothing conspiratorial about independent verification of evidence, especially given testing development protocol errors documented above. Indeed, such efforts for independent verification should be lauded. To be crystal clear, the investigators are not denying that research studies have been conducted to isolate Sars CoV2, a point that 'fact checkers' often bring up in denouncing credible investigative efforts of Sars CoV-2 isolation. Rather, researchers are questioning whether the studies were conducted as to properly isolate and establish the existence of a new, novel coranvirus documented as Sars CoV2, the virus attributed to Covid-19.
Due to the complexity of the subject, and the profound implications to improper determination of a new, noval coronavirus, many media & independent commentators have ignored evidence that Sars CoV2 was not properly isolated. However, the objective evidence demonstrating proper viral isolation and determination did not occur should not be ignored because the implications are problematic. The scientific method does not exclude credible data because it is inconvenient to established narrative.
Independent researchers submitting Freedom of Information act requests to government organizations and universities tasked with conducting the isolation studies have been unable to verify Sars CoV2 isolation has ever occurred from a sample from an infected human subject.
All Freedom of Information act requests submitted have come back without being able to present substantive documentation of proper Sars CoV2 isolation from a sample taken from a human subject infected with Sars CoV2.
As this subject is complex, and it is outside the expertise of this blog to provide anything other than a cursory review of evidence around the subject of isolation, the following links are provided for further investigation into this study. From our review of presented data, it does not appear that the Sars CoV-2 virus isolation has been appropriately verified by proper scientific standards. Our review of 'fact chceks' did nothing to answer the core concerns presented by researchers, the issue having nothing to do with how many isolations studies were done, but rather, if these studies were conducted in a manner to correctly isolate and verify Sars CoV2 for development of accurate testing and vaccination treatments.
We encourage our readers to review the available data, and come to conclusions on review of all available evidence. The refutations made by mainstream news outlet obfuscate the actual concerns of researchers into the issue rather than substantively addressing specific concerns:
Recommended reading on the subject of virus isolation includes:
PCR Tests Are Scientifically Meaningless (direct inquiry from investigators to researchers conducting studies for Sars CoV-2 isolation)
(excellent discussion on what is required for proper virus isolation and establishment of new viral classification of disease)
Library of Freedom of Information requests submitted by Christine Massey for determination of proper isolation of Sars CoV-2
And, a excellent video breaking down problems with current virology methods of virus isolation, excellent for the layperson, this entire channel is recommended viewing:
Evidence indicates SaRs CoV-2 illness actually originated from bacterial infection:
Review of evidence for proper isolation of Sars CoV2 is not a refutation against individuals dying in pocket clusters of illness last Spring with majority of cases found to have occurred in nursing homes. It is examination into the question of what is the actual cause of those deaths.
The WHO policy was discouraging autopsy review of evidence in the spring of 2020 when the death clusters began occurring. However, several countries broke with these recommendations and conducted independent autopsy into the deaths attributed to Sars CoV2 infections. These autopsies revealed the deaths were coming from bacterial and not viral origin:
"Doctors in Italy, Germany and India who autopsied patients found many COVID-19 cases are actually BACTERIAL rather than a virus. Many cases point to thrombosis as cause of death. Recommended treatments should include blood thinners such as simple aspirin.
In Italy doctors who broke with the World Health Organization (WHO) protocols were able to effectively treat COVID-19 once they recognized many cases were nothing other than “Disseminated intravascular coagulation” (Thrombosis).
Having discovered this diagnosis, the Italian Ministry of Health immediately changed the coronavirus treatment protocols and began to administer to their CV-19 positive patients Aspirin 100mg and Apronax. These patients began to recover and as a result of this new method, the Ministry of Health released and sent home more than 14,000 patients in a single day".
Chart documenting cause of death in patients with attributed Sars CoV2 infection:
It is documented that many Covid-19 deaths are occurring due to secondary bacterial infections in individuals diagnosed with Sars CoV2. However, due to the fact that Sars CoV2 testing is unsuitable for detection of the virus, the infections may not be secondary to Covid-19 infections. Bacterial secondary infections are common in hospital settings.
There are numerous studies documenting a high percentage of individuals who are dying of bacterial infections in deaths attributed to Sars CoV2.
"This study aimed to investigate the frequency and characteristics of respiratory co-infections in COVID-19 patients in the intensive care unit (ICU). In this retrospective observational study, pathogens responsible for potentia