Archive for the ‘Testing’ Category

LymeX Prize Competition Announces Ten Phase 1 Winners

https://www.change.org/p/the-us-senate-calling-for-a-congressional-investigation-of-the-cdc-idsa-and-aldf/u/31127539

LymeX prize competition announces ten Phase 1 winners

Carl Tuttle

Hudson, NH, United States

NOV 30, 2022 — 

Please see the following letter sent to all winners of the LymeX prize…

———- Original Message ———-
From: CARL TUTTLE <runagain@comcast.net>
To: “contact@steveandalex.org” <contact@steveandalex.org>
Cc: The Tick-Borne Disease Working group and all winners of the LymeX prize
Date: 11/30/2022 1:12 PM
Subject: LymeX prize competition announces ten Phase 1 winners

November 7, 2022

LymeX prize competition announces ten Phase 1 winners
https://www.lymedisease.org/lymex-phase-one-winners/

“The ultimate goal of the multiphase competition is to nurture the development of diagnostics toward Food and Drug Administration review.” 

To all winners of the Phase 1 LymeX Diagnostics Prize competition,

After spending the last thirteen years studying the mishandling of Lyme disease, I felt compelled to share the following facts (and supporting documentation) regarding prior attempts to introduce “new and/or improved” diagnostic detection methods. I concluded that a chronic relapsing seronegative disease does not fit the business model of vaccine development, patent royalties and pharmaceutical profits so laboratory confirmation of persistent infection after antibiotic treatment must be squelched/suppressed at all costs.

Examples

1. Culture: Advanced Laboratory Services

Barbara J.B. Johnson, microbiologist with the Centers for Disease Control and Prevention claimed laboratory contamination in reference to positive test results (Chronic Lyme) found in Advanced Laboratory Services’ Borrellia culture test. If this is the case, why didn’t the CDC work with Advanced Laboratory Services to perfect its culture test and resolve the so-called “contamination” issues?

New Lyme Culture Test Failed CDC Analysis Aug 20, 2013
http://www.medscape.com/viewarticle/809626

New CDC/FDA Warning Against Unapproved Lyme Culture Test
https://www.medscape.com/viewarticle/823840

“Dr. Nelson emphasized that for Lyme disease diagnosis, the CDC recommends a 2-step process of serologic testing: first, an FDA-cleared enzyme immunoassay, followed in immunoassay-positive or equivocal cases by confirmatory Western blot. Only patients positive on both tests are considered to have Lyme disease.”

Carl Tuttle’s comment: Current FDA approved Lyme disease tests (Antibody tests) cannot be used to gauge treatment failure or success which makes them ideal for concealing an antibiotic resistant/tolerant superbug allowing the thirty-year-old dogma to remain intact.

2. PCR testing:

We have seen similar actions from the CDC with PCR testing as well. In May of 2012 the CDC announced the Development of a Novel Genus-specific Real-time PCR Assay for Detection and Differentiation of Bartonella Species and Genotypes:  http://www.ncbi.nlm.nih.gov/pubmed/22378904

Here the CDC is using PCR for a definitive diagnosis of Bartonella however, according to the CDC and the ALDF group on June 11, 2012 PCR cannot be used for Lyme diagnosis per the CDC expert commentary posted on Medscape below:

PCR for Diagnosis of Lyme Disease: Is It Useful? Christina A. Nelson, MD, MPH
https://www.medscape.com/viewarticle/764501

Quotes from Christa Nelson: (Medical Officer in the Bacterial Diseases Branch of CDC’s Division of Vector-Borne Disease)

“Is PCR useful for the diagnosis of Lyme disease? In general, the answer is no.”

“Two-tiered serology remains the mainstay of laboratory testing for Lyme disease.”

Carl Tuttle’s comment: PCR is acceptable for Bartonella but not Lyme disease. Double standard here?

3. Nested PCR and DNA sequencing: Milford Molecular Diagnostics

In September of 2012 the CDC entered into an agreement with Dr. Sin Lee to evaluate the viability of his DNA sequencing technology. Martin E. Schriefer, Ph.D., the chief of the CDC’s diagnostic and reference laboratory, stated the following: (from the attached court document)  https://www.dropbox.com/s/8irsb6oqunwy3zq/Notice%20of%20Appeal.pdf?dl=0

“So wherever possible we encouraged and required other non-serologic-based tests in addition to clinical presentation so that might have included PCR or culture or both. . . . And again I’m looking forward to seeing a greater utilization of PCR as a diagnostic tool in the future.” -Martin E. Schriefer, Ph.D.

When Dr. Lee published a case of persistent infection (Chronic Lyme disease) in 2014 all communication with the CDC ended abruptly with no explanation.

DNA Sequencing Diagnosis of Off-Season Spirochetemia with Low Bacterial Density in Borrelia burgdorferi and Borrelia miyamotoi Infections  http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4139787/

Carl Tuttle’s Comment: It should be noted that the chronic Lyme disease case identified in this publication was found in blind-coded serum samples sent to Dr. Lee’s laboratory from the CDC’s Lyme disease serum repository and other species of Borrelia were found within these samples using DNA sequencing; the CDC had no idea that multiple pathogens were involved.

Has the CDC purposely discredited other innovative technologies which are in competition to the invention being patented by Theresa M. Russell and Barbara J.B. Johnson of the NCEZID under Pub. No. WO 2013110026 A1 entitled “Compositions and methods relating to Lyme disease”?

Dr. Lee although participated in the competition, was not awarded the LymeX prize. Does anyone believe that this decision was just a coincidence?

4. NIST

New Experimental Test Detects Signs of Lyme Disease Near Time of Infection February 11, 2016
https://www.nist.gov/news-events/news/2016/02/new-experimental-test-detects-signs-lyme-disease-near-time-infection

“The current standard blood test for Lyme disease exposes the infection only after antibodies have accumulated to detectable levels, which can take up to 4 to 6 weeks. If patients exhibit a telltale bull’s-eye rash, diagnosis and treatment can begin earlier. But the rash does not occur in 20 to 30 percent of Lyme disease patients, according to the Centers for Disease Control and Prevention.

Rather than waiting for an infected person’s immune system to produce noticeable amounts of antibodies, the team chose to home in on the bacteria itself—specifically, proteins the bug sheds when attacked by the body’s defenses.

“From many candidates, we chose one that is both easily distinguished from human serum proteins and an unambiguous indicator of the bacteria,” Turko says. “This protein, which resides on the outer surface of membranes, became the target of our search in serum samples.”

Carl Tuttle’s comment: Response from Dr Illarion Turko; “This project did not receive further development and is on-hold for now.”

So, who at the CDC got to Dr. Turko and discouraged further development?

Other examples of interference/intimidation

In 2008 Nordin Zeidner published his study regarding single dose Doxycycline for tick bite. Pamela Weintraub interviewed Zeidner for her book:

Cure Unknown (Revised Edition): Inside the Lyme Epidemic

By Pamela Weintraub

https://books.google.com/books?id=

Excerpt:

“Immunologist Nordin Zeidner, chief of the CDC’s Vector-Host laboratory in Fort Collins, Colorado, told me internal agency studies had found the strategy questionable, and definitely ineffective in mice.”

“With the support of his CDC colleagues, Zeidner had begun to work with industry to develop an alternative: a form of injectable Doxy that could be sustained in the body for nineteen days.”

“Trying his formulation on mice, Zeidner found that 100 percent were protected from Lyme as well as the coinfection, anaplasmosis.”

“…..single dose doxy stopped Lyme disease not in 87% of mice, but rather, in 20 to 30 percent at most.”

_____________________________

Dr Gary Wormser of New York Medical College (who has controlled the Lyme disease narrative for the past three decades) published a study earlier promoting the use of single dose Doxy for tick bite. (See Wormser’s 2001 flawed NEJM article)

I understand that it was Wormser who called Zeidner’s superiors at the CDC to put an end to Zeidner’s work. Zeidner was told to discard the mice sera instead of testing for antibodies as he had promised.

Zeidner’s research was terminated for “lack of industrial support” Mead, and he was promoted, and his email address inactivated. The CDC stopped his research and sent him to Europe

I have attached Zeidner’s 2008 study for your review:

A sustained-release formulation of doxycycline hyclate (Atridox) prevents simultaneous infection of Anaplasma phagocytophilum and Borrelia burgdorferi transmitted by tick bite
https://www.dropbox.com/s/jc0h9g9arjhc8l1/Zeidner%202008.pdf?dl=0

Questions for LymeX prize competition winners:

Are all of you confident that the current pandemic was handled properly by our Public Health Officials? Was diagnostic testing controlled/manipulated in any way? Have lifesaving therapies been suppressed over pharmaceutical profits (vaccines)?

I ask the competition winners to be suspect of HHS oversight for this LymeX prize competition and if any dishonest/suspicious activity is experienced as described previously in this letter, please seek early legal counsel, (perhaps collectively) and involve your state senators to expose the ongoing corruption hell bent at maintaining the false thirty-year Lyme disease narrative: “Lyme is Hard to Catch and Easily Treated” (with a 2-4wk antibiotic treatment mandated by the Infectious Diseases Society of America)

Respectfully submitted,

Carl Tuttle
Hudson, NH

Cc: All LymeX prize competition winners, All members of the 2022 Tick-Borne Disease Working Group, the Steven & Alexandra Cohen Foundation

More examples of interference/manipulation as reported through the experience of a clinician on the front lines:

2018 ILADS Webinar – History of Lyme Disease by Joseph J. Burrascano, Jr. MD. (Video Recording)
https://vimeo.com/306846706  Summary:

Joseph Burrascano, MD’s cogent history of Lyme: East Hampton, Long Island NY had the highest rate of Lyme in the world. 1965 internist Sidney Robin coined the term “Montauk Knee”.

1985   87 seronegative patients all had spirochetes produced using Alan McDonald’s culture technique. “Seronegativity is real”

@7:00  re: PTLDS – “There’s never, ever, ever been a description of this Post Lyme Syndrome from an immunological point of view that clarifies what it is and applies to every single patient”.

@9.05 Stony Brook study of 21 day doxycycline “… had a 100% FAILURE RATE… THEY KICKED ME OUT OF THE STUDY AFTER THAT; AND THEY NEVER REPORTED THOSE RESULTS.”

@9.35 Patient Evaluation: “I took advantage of Dr. McDonald’s culture… after treatment ended, if you waited a few weeks, they [patients] were all culture positive. It was failed treatment and a persistence of the infection.”

@12.45  Late 1980’s “Rocephin came onto the scene… 100% failure rate of 2 weeks of Rocephin, even at high dose… Duration of treatment is really, really what’s important.” Findings presented @ 1990 Stockholm International Conference.

@13.50  633 patient records reviewed indicated at least 4 months treatment for those “with multiple bites, Lyme arthritis, heart murmurs, hormonally active women, those sick for more than 1 year, age over 60, acute carditis, documented immune deficiency, failed oral treatment.”

@26.50 Discovered on lecture circuit Dr. Ed Masters from MO, John Druhl, NJ & Paul Levy, San Francisco all independently concluded higher doses and longer treatment necessary. They’d never met or communicated previously.

1990 NIH Gold Stain – 73 chronic patients, 13.5 months mean treatments. Discovered blebs and biofilms.

@31.19 “So, whatever happened to this great gold stain? Know what? Nothing. NIH stopped the funding… closed the whole thing down and never again did they ask front line Lyme doctors to contribute specimens to their studies. So, there’s some politics one more time.”

@32.58 Co infections seem to affect only chronic Lyme patients.

@34.19 Lyme is the thing that takes over the immune system, weakens our defenses….

@36.52 Lyme is an immune suppressive illness….

@38.25 McDonald presented cultures at “… a meeting of NYS Medical Society… detractors were people from Yale and Stony Brook who didn’t want their patented serologic tests to be usurped, and they started claiming that McDonald was falsifying his data and so forth.”

Category:

Activism, Lyme, Testing, vaccines

Examining Bartonella With Dr. Burrascano

http://

Examining Bartonella With Dr. Burrascano

Nov. 1, 2022

Go here for time signatures with topic headings.

For more:

Category:

Bartonella, Psychological Aspects, Testing, Ticks, Treatment

Swamp Boy: A Teen With Bartonella

https://nowthisnews.com/swamp-boy  Go here for the comic By Kris Newby

Illustrated by Mado Peña. Additional editing by Joshua Davis and Gina Mei.
Co-published in partnership with Epic Magazine.

In 2015, the day before Halloween, a mild-mannered teenage boy suddenly became delusional. He informed his parents that a demonic voice had begun speaking to him. Over the next weeks, his psychosis deepened: He believed he had transformed into his favorite comic book character, the Swamp Thing. And he was convinced that a family cat was possessed and was telepathically instructing him to murder his own brother.

The family panicked. What the hell happened to their sweet boy? Doctors pronounced that the teen had sudden-onset schizophrenia and he was repeatedly sent to a psychiatric ward. “Schizophrenia from one day to the next?” his parents wondered, dumbfounded. The specialists had few answers, so the parents began an 18-month journey to solve the mystery on their own.

This harrowing medical mystery was published in collaboration with NowThis and illustrated by comic artist Mado Peña, who brought the teenage boy’s hallucinations to life.

_________________

**Comment**

This comic is based on the true story of a 14 year teenager with Bartonella which highlights how this common illness can manifest psychiatrically.  It really is a “must read” and should be given to anyone who doesn’t believe how devastating it can be.  Although it’s presented in comic-strip formatting, the material is as serious as a heart attack.

To learn more about Bartonella history, diagnosis, and treatments, watch the medical education courses on Invisible International’s Montecalvo Tick-borne Disease Education Platform.

For more:

Category:

Bartonella, Psychological Aspects, Testing, Ticks, Treatment

RMSF Masquerading as Gastroenteritis

https://blog.redlaboratories.be/2022/10/rickettsia-rocky-mountain-spotted-fever

Rickettsia – Rocky Mountain Spotted Fever Masquerading as Gastroenteritis

 Thursday, October 13, 2022
By R.E.D. Laboratories

The recent article by Braun et al. explains the importance of test for Ricketissa tick-borne infection. This infection can hide numerous symptoms like fever, rash, gastrointestinal symptoms such as anorexia, nausea, vomiting, and abdominal pain.

The article: Rocky Mountain Spotted Fever Masquerading as Gastroenteritis: A Common but Overlooked Clinical Presentation, shows a case of a 20-year-old male presented to the emergency department with many alarming symptoms.

It is important to test for Rickettsia in order to help identifying infection rapidly as well as avoid expensive workups and invasive procedures which may delay the needed treatment.

To ensure the detection of Rickettsia infections, R.E.D. Laboratories propose the new Phage Rickettsia test which can uncover a broad range of Rickettsias: Rickettsia japonica (multiple strains); Rickettsia heilongjiangensis (multiple strains); Rickettsia parkeri (multiple strains); Rickettsia raoultii (multiple strains); Rickettsia rickettsia (multiple strains); Rickettsia slovaca (multiple strains); Rickettsia montanensis; Rickettsia peacocki; Rickettsia africae; Rickettsia conorii.

Request Form EU

Request Form USA

For more:

Category:

Gut Health, research, Rocky Mountain Spotted Fever, Testing, Ticks, Transmission

Science, Public Health Policy & the Law Has Accepted Dr. Sin Hang Lee’s Study of the Flaws of Non-Quantitative RT-PCT For SARS-CoV-2 Detection – Part 1

**UPDATE**

Go here for another excellent read on how for a 5% prevalence rate for COVID infections in a population, the 42% false positive discovery rate means that for every 50 true positives, there will be 36 false positives.  Ponder that for a moment.

COVID cases will be overstated by a factor of 72%

Due to unreliable of PCR tests:

There are no credible COVID-19 ‘vaccine’ trial data.

https://popularrationalism.substack.com/p/science-public-health-policy

Science, Public Health Policy & the Law has Accepted Dr. Sin Hang Lee’s Study of the Flaws of Non-Quantitative RT-PCR for SARS-CoV-2 Detection – Part 1

Sanger Sequencing Provides Definitive Evidence that RT-PCR Use with No Internal Control Applied to the Problem of Diagnosis of COVID-19 is Fatally Flawed

James Lyons-Weiler

When the German team (Cormen et al. (aka “Drosten Report”)) published primers capable of detecting synthetic oligonucleotide that matched parts of the SARS-CoV-2 genome sequence published from the first clinical sample from the first patient diagnosis of pneumonia associated with a novel coronavirus, there was hope that the virus might be controlled at least until healthcare facilities could be made ready using the training and preparations they conducted during the Ebola care of 2014.

The use of PCR to detect specific sequences is trivially non-controversial, if it is done in an expert manner. First, the primers are chosen computationally to match only the target species (or quasi-species, in the case of viruses). Second, multiple targets can be selected that help nail down the results in case one of the single. Finally, if the primers are nested or hemi-nested – that is if the targets sequences overlap, a local sequence can reliably be determined on a percentage of the samples as a direct gold-standard check to estimate both the true positive rate (the probability of detecting a virus that is truly present) and the false positive rate (the probability of detecting the target when it is truly not present).

I expected when CDC’s PCR test failed that there would likely be a variety of approaches that would be developed by commercial nucleic acid technology companies. I started advocating for private mass testing, with an emphasis on “private”, expecting that accurate testing would emerge.

I was astonished when I saw that the FDA had only requested that commercial suppliers provide data on the true positive rate, but no data on the false positive rate. Worse, I was astonished to learn, upon reading the documents being submitted to the FDA, that the test kit manufacturers were not including positive control sample material to allow the determination of cycle threshold (Ct) by which one makes the call for a given patient that the virus was present or absent. Cycle thresholds are the number of rounds of amplification necessary to reach a specific point in the exponential growth of the number of copies of target sequences. This must be done for each patient separately – even if the test is the same kit done in the same lab, on the same day, by the same technician – because the amount of starting material in each swab varies.

This was the first time I had ever seen any RT-PCR-based test NOT use a positive control sample. The lack of a positive control sample means that the assay was qualitative, not the robust and rigorous qRT-PCR (“q” stands for “quantitative”. For example, even the RT-PCR test for the Monkeypox virus uses a positive control sample.

Instead of using empirically derived Ct values per patient, generic Ct values were used. These were part of the kits, but they were not published. This was unusual. I asked medical freedom activists to request from their local health department what Ct values were being used to determine a diagnosis for a patient. Multiple people did, and the reply was the same: that information is proprietary. This was ridiculous; the exact Ct being used is not a top-secret part of a test, but is, instead, an essential aspect of checking the reliability of the results of an RT-PCR test.

Go to top link for a video on RT-PCR.

The absence of a positive control target sample was a big deal because, without any data on whether tests were hitting human sequences via off-target amplification, many people would be “diagnosed” with COVID-19 who were not infected. This would not only be disruptive – the resulting huge numbers of false positives could be used to justify police actions as was going on in China at the time.

Further, people who had other respiratory illnesses like influenza, respiratory syncytial virus, bacterial pneumonia, the common cold, or other coronaviruses might not be given appropriate medical care given the isolate-and-do-nothing approach to COVID-19. Many would die from severe pneumonia that could have been prevented via medical intervention, just as antibiotics for bacterial pneumonia.

Also, it was clear that many people who were sick but did not have COVID-19 would believe thereafter they were immune, and they might risk exposures that they otherwise might not risk.

In addition, those that did then become infected after their false positive COVID-19 test might then doubt their actual case of SARS-CoV-2 infection was worth testing for and they might fail to protect others who were at the highest risk of death from COVID-19 infection – the immunocompromised and the elderly.

So I wrote to the FDA with my concerns. Dr. Peter Marks wrote back with a terse “Thank you, we will take your concerns up with my team”.

At the same time, Dr. Sin Hang Lee independently saw the same issues and was motivated to develop a Sanger sequencing-based test. His approach circumvented the risk of false positives altogether by using primer pairs that targeted parts of the SARS-CoV-2 genome in an overlapping mapper. This way, he could tell if he truly had the sequence of interest in a sample, or if one of the primer pairs was failing due to a mutation in the primer site.

Dr Sin Hang Lee in his laboratory in Milford, CT.

Dr. Lee is an extremely capable and experienced scientist and is an expert in molecular diagnosis and diagnostic pathology. The fact that he independently came to the same conclusion as I did on the risks of using RT-PCR the way CDC, ultimately, FDA allowed under emergency use authorization gave me hope.

July 2020 WWDNYK’s Unbreaking Science: CDC PCR Test Wrong 1/4 of the Time

See top link for a video from about the time I contacted FDA (Nov 2020).

After writing various blog articles and doing podcasts attempting to alert the public and health departments to these very serious issues, I was invited to testify in a case in Pennsylvania wherein a restauranteur was sued by the Commonwealth for not following the public health dictates regarding her customers.

Originally, the testimony was meant to be written. So I provided the judge with the scientific literature on measured false positive rates of the RT-PCR tests. There were about four studies that provided data that demonstrated that the false positive rates varied from 11% (Basile et al.) to as high as 38% (the Duke Marines study).

The State Epidemiology submitted her testimony at the same time, without seeing mine. (I did not see hers, either). When I was given a copy of her testimony, I could see she knew nothing about the state of the science on the use of RT-PCR as allowed by CDC and PCR. She reported to the judge in her written testimony that RT-PCR tests for COVID-19 had – get this – ZERO false positives.

That’s when the judge, for reasons I will never understand, refused both sets of written testimony, and instead decided that only verbal testimony was going to be allowed. Of course, the State’s lawyer used the only tool they had – ad hominem attack – to try to discredit me. But even that didn’t change the fact that RT-PCR tests were visiting abuse on the public via false positives as outlined above.

A group of people became increasingly aware of the issues, and together we created NAATEC, the Nucleic Acid Assay Technology Evaluation Consortium – to collect public funds and fund the comparison of RT-PCR testing to Sanger sequencing.

I am happy to report that we thereby funded research by independent research scientist Dr. Sin Hang Lee to conduct the evaluation that FDA should have required by PCR test kit manufacturers.

The study underwent a single-blind peer review with two independent reviewers not involved in the study. The peer reviewers were scientists and experts in the field. After two rounds of feedback from the reviewers, the manuscript was accepted for publication and is with the editorial production team.

Prior to publication, I am providing the title, author, and Abstract.

Evidence-Based Evaluation of PCR Diagnostics for SARS-CoV-2 and the Omicron Variants by Sanger Sequencing

Dr. Sin Hang Lee

Abstract: Both SARS-CoV-2 and SARS-CoV-1 initially appeared in China and spread to other parts of the world. SARS-CoV-2 has generated a COVID-19 pandemic causing more than 6 million human deaths worldwide while the SARS outbreak quickly ended in six months with a global total of 774 reported deaths. One of the factors contributing to this stunning difference in the outcome between these two outbreaks is the inaccuracy of the RT-PCR tests for SARS-CoV-2, which generated a large number of false-negative and false-positive test results that have misled patient management and public health policymakers. This article presented Sanger sequencing evidence to show that the RT-PCR diagnostic protocol established in 2003 for SARS-CoV-1 can in fact detect SARS-CoV-2 accurately due to the well-known ability of the PCR to amplify similar, homologous sequences. Using nested RT-PCR followed by Sanger sequencing to retest 50 patient samples collected in January 2022 and sold as RT-qPCR positive reference confirmed that 21 (42%) were false-positive. Routine sequencing of the RT-PCR amplicons of the receptor-binding domain (RBD) and N-terminal domain (NTD ) of the Spike protein (S) gene is a tool to avoid false positives and to study the effects of amino acid mutations and multi-allelic SNPs in the circulating variants for investigation of their impacts on vaccine efficacies, therapeutics. and diagnostics.

The study was partially funded by IPAK via the NAATEC. To support research like this, visit http://ipaknowledge.org/

Watch for Part 2 at the end of the month – the details of the study will be explained.

_________________

**Comment**

Dr. Lee is an unsung hero who has been outspoken many times against medical injustice:

Category:

Activism, research, Testing, Viruses