Archive for the ‘Testing’ Category

Dr. Robert Gallo Talked to NBC News About What’s Needed in an Antibody Test For the Coronavirus.

https://www-nbcnews-com.cdn.ampproject.org/c/s/www.nbcnews.com/news/amp/ncna

200414-robert-gallo-cs-117p_374d93e4de47337c32585dcef4d0f1f9.fit-1240wDr. Robert Gallo, a specialist in AIDS research, in a lab in 1984. Bettmann Archive via Getty Images file

Dr. Robert Gallo talked to NBC News about what’s needed in an antibody test for the coronavirus.

April 14, 2020

By Lauren Dunn and Sara G. Miller

The race is on to develop and distribute antibody tests for the coronavirus, driven by the idea that these tests will inform individuals when they are immune to the virus and can return to their normal lives.

This isn’t the first time there’s been an urgent need for an antibody test. In the 1980s, it was a different crisis: HIV/AIDS. Unlike the coronavirus, a positive antibody test for HIV means that a person is currently infected with the virus, meaning the test could be used to diagnose. (See link for article)

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**Comment**

Great read which helps clarify antibody testing – what it can do and what it can’t.

Key take-aways on why antibody testing is important:

  • helps us know the extent of the epidemic by following its spread
  • better able to predict the future by finding out whether the antibodies are correlating with doing anything
Gallo cautions us; however, that antibody testing has limitations:
  • current antibody testing can’t distinguish between protective antibodies and infectious antibodies, so even people with positive antibodies can be very infectious
  • there can be cross-reactions to other coronaviruses which would give a false positive (the person shows antibodies for COVID-19 but really is infected with another milder coronavirus)
Gallo states that for an antibody test to be effective it needs specificity and sensitivity for the best accuracy.

Important quote:

I’d like to say there are antibodies and there are antibodies and there are antibodies. Some are nothing at all. Some are protective indicators. And sometimes, though not so commonly, they can make matters worse.

He also disagrees with those who state that if you develop antibodies you won’t get sick again because it takes very specific kinds of antibodies at a high enough titer to be truly protected.

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**Comment**

This article helped clarify a number of things for me. I’ve wondered if you are exposed to and develop antibodies for COVID-19 if like in the case of Chicken Pox, for instance, you typically develop life-long immunity OR if like the seasonal flu which has many different strains, you can continue to get various deviations of the flu year after year.  I’ve heard arguments for both scenarios.

Time will answer this question, but I have profound faith in the human body – either way.

Gallo’s information about antibody testing is similar to antibody testing for Lyme: https://madisonarealymesupportgroup.com/2018/10/12/direct-diagnostic-tests-for-lyme-the-closest-thing-to-an-apology-you-are-ever-going-to-get/  Excerpt:

The 1994 serodiagnostic testing guidelines predated a full understanding of key B. burgdorferi antigens and have a number of shortcomings. These serologic tests cannot distinguish active infection, past infection, or reinfection.

Also, in this article, Dr. Waisbren, a LLMD who practiced in Wisconsin but is no longer with us:

About testing he states that the Western Blot appears to be the most positive finding in clinical LD, but…“setting arbitrary level of antibodies to diagnose a disease that has not been amenable to Koch’s postulates seems open to question.  By the same token, ignoring antibody results unless they meet arbitrary levels seems suspect.  The vast majority of patients in this series showed some WB antibody exposure, but many did not meet the arbitrary limits set….in our present state of knowledge, the diagnosis of chronic Lyme disease is a clinical one.  Many of the patients in this series have suffered serious ‘hurts’ when they have been told that they could not have LD because their WB did not meet arbitrary limits.”  https://madisonarealymesupportgroup.com/2017/07/09/idsa-founder-used-potent-iv-antibiotics-for-chronic-lyme/

Another issue for COVID-19 testing is the fact our own CDC wouldn’t accept an already proven test months ago because it insisted upon having its own.  It STILL does not have an accurate test to this day. This article shows that there are dozens of antibody tests on the market never vetted by the FDA:  https://www.inquirer.com/health/coronavirus/coronavirus-covid-fda-criticized-antibody-tests-serology-testing-accuracy-20200419.html

To read more about the CDC’s insistence upon having it’s own test:  https://madisonarealymesupportgroup.com/2020/03/27/cdcs-deadly-testing-fiasco-centralization-of-public-health-authority-a-threat-to-national-security/

The reason for this is to control all the parameters so they can go on to create test kits, drugs, and vaccines – all for profit – making them direct competitors to the private sector. This has been going on for decades. In the case for Lyme – the CDC bad-mouths any private testing lab – and has literally called them “home-brewed,” which is not an endearing term when you want accuracy – yet these CLIA-certified labs are more accurate than current CDC two-tiered testing. So, when you read about testing, please understand there’s a long back-story of collusion, fraud, profitteering, and slander to anyone outside the CDC.

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For more on COVID-19 Testing:  https://madisonarealymesupportgroup.com/2020/04/20/covid-19-testing-in-boston-homeless-shelter-100-of-positives-had-zero-symptoms/

https://madisonarealymesupportgroup.com/2020/04/15/covid-19-testing-in-chicago-30-50-already-have-antibodies-milwaukee-man-given-plasma-transfusion-from-recovered-patient/

https://madisonarealymesupportgroup.com/2020/03/21/study-shows-covid-19-testing-as-bad-as-lyme-msids-testing/

https://madisonarealymesupportgroup.com/2020/04/04/coronavirus-testing-kits-heading-to-the-uk-found-to-be-contaminated-with-covid-19/

 

 

 

 

 

The Tension Between Public Health & Patents In The Era Of COVID-19

https://www.statnews.com/2020/04/14/patents-public-health-tension-covid-19/

The Covid-19 pandemic, devastating as it is, is producing some triumphs of collaborative research and innovation, as everyone from the World Health Organization to national laboratories, pharmaceutical companies, and Facebook groups of engineers race to fight the virus. But lurking behind this remarkable work is a threat: Some individuals or companies may exploit patents to profiteer off the crisis and could slow these innovative efforts to a crawl.

In this time of crisis, lawmakers must be wary of patents and be flexible and proactive in using the many legal tools available to check their harmful use. (See link for article)

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**Comment**

Great reminder of an all important topic Lyme/MSIDS patients are all too aware of: conflicts of interests slowing or even stopping true scientific progress.

Recently, regarding COVID-19, I posted that the Chinese are trying to patent the anti-viral, Remdesivir:  https://madisonarealymesupportgroup.com/2020/04/17/live-video-chat-remdesivir-data-chicago-hospital-seeing-rapid-recoveries-patients-discharged-in-less-than-a-week/There is currently a clinical trial for Remdesivir in which they are finding:

rapid recoveries in fever and respiratory symptoms, with nearly all patients discharged in less than a week.

A similar effect was found in rhesus monkeys:  https://www.nih.gov/news-events/news-releases/antiviral-remdesivir-prevents-disease-progression-monkeys-covid-19

Regarding Lyme/MSIDS, microbiologist Tom Greer recently wrote an excellent letter outlining this problem of conflicts of interests and patents: https://madisonarealymesupportgroup.com/2020/04/19/letter-to-chronic-lyme-denialists-from-a-microbiologist/

A while back, I too wrote an article highlighting the problems with the faulty research that continues to be done – ignoring an entire LARGE subset of people who have remaining symptoms:  https://madisonarealymesupportgroup.com/2019/02/22/why-mainstream-lyme-msids-research-remains-in-the-dark-ages/  The authorities continue to fixate on the acute stage of the disease as well as insist upon having positive blood serology when research has proven Lyme tests relying upon antibodies to be worthless. They also insist that patients have the EM rash to enter studies, when research also shows many never get a rash.

For more on Lyme testing: https://madisonarealymesupportgroup.com/2018/10/12/direct-diagnostic-tests-for-lyme-the-closest-thing-to-an-apology-you-are-ever-going-to-get/

Excerpt:

The 1994 serodiagnostic testing guidelines predated a full understanding of key B. burgdorferi antigens and have a number of shortcomings. These serologic tests cannot distinguish active infection, past infection, or reinfection.

COVID-19 Testing in Boston Homeless Shelter: 100% of Positives Had ZERO Symptoms

https://www.boston25news.com/news/cdc-reviewing-stunning-universal-testing-results-boston-homeless-shelter/ Video in Link

CDC reviewing ‘stunning’ universal testing results from Boston homeless shelter

The Centers for Disease Control and Prevention is now “actively looking into” results from universal COVID-19 testing at Pine Street Inn homeless shelter.

 

BOSTON — The Centers for Disease Control and Prevention is now “actively looking into” results from universal COVID-19 testing at Pine Street Inn homeless shelter.

The broad-scale testing took place at the shelter in Boston’s South End a week and a half ago because of a small cluster of cases there.

Of the 397 people tested, 146 people tested positive. Not a single one had any symptoms. (See link for article)

 

Letter To Chronic Lyme Denialists From A Microbiologist

To The Chronic Lyme Denialists

By Tom Grier

I am not writing to champion “chronic-Lyme-disease” or the many charlatans that create imaginative cures for vague symptoms, I am here to point out a couple facts that are always missing from articles criticizing chronic Lyme disease.

First of all, from the very beginning when Lyme disease was first discovered to be caused by the spirochete Borrelia burgdorferi, the Medical-Experts based all of their conclusions on serology tests.

At that time the patents for the ELISA serology tests from the CDC were held by seven top level CDC administrators, a clear financial conflict of interest in my eyes when stated were mandated to use the CDC tests that lasted the full length of their PATENTs and only ended when their patents expired. Odd coincidence???

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All the serology tests for Lyme disease are based on B-31 lab strain of Borrelia burgdorferi we now have 19 Lyme disease Borrelia species and only Bb is detected with these tests. Also Borrelia myamotoi (a TBRF), which is found in the same tick as Lyme disease is transmitted in just 20 minutes. So the theory that Lyme disease can’t be transmitted within 36-48 hours (Yale Medical Report by Marc Voortman) is allowing an undetectable Tick-Borne-Relapsing-Fever to enter the patients and despite Lyme-like symptoms the patients will always test negative on a Lyme disease ELISA test.

The medical experts got many things wrong since 1982:

  • No transplacental transfer (Gary Wormser and E. Shapiro)
  • Is not intracellular (Alan Barbour) 
  • Lyme ELISA tests are 99 % accurate (CDC website) 
  • Erythema-migrans Lyme rash must be the size of a basketball or bigger (Dr. Johann Bakken 2016 IDSA President) 
  • No one dies of lyme disease
  • Two-Tiered testing is better than a single test
  • Many more inaccurate statements continue to be propagated by the Lyme disease experts of yesteryear. Graphic shows more:

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So to find the truth, our group and others turned to PATHOLOGY as the gold standard, and what we found warrants the need for an International Multi-Center Tax-Payer funded Brain Autopsy Study to detect all Borrelia species in the deaths of Chronic Lyme patients, MS patients and dementia brains.

All pseudo-science aside: Lyme patients deserve better science and better studies based on PATHOLOGY not SEROLOGY.
Do the Brain Pathology first, then make your conclusions.

Thomas Grier, Study Administrator
Dr. Paul Duray Pathology Fellowship (A volunteer organization)

218-216-5670 / donatebrain@gmail.com

tomgrier@gmail.com

 

 

 

 

More of the Same Focus on Worthless Serology Testing For Borrelia Research

https://www.change.org/p/the-us-senate-calling-for-a-congressional-investigation-of-the-cdc-idsa-and-aldf/u/26304991?

More of the same focus on Serology!

Ticks and Tick-borne Diseases

Identification of immunoreactive linear epitopes of Borrelia miyamotoi
https://www.sciencedirect.com/science/article/pii/S1877959X1930353X

Rafal Tokarz, Teresa Tagliafierro, Adrian Caciula, Nischay Mishra,b, Riddhi Thakkar, Lokendra V. Chauhan, Stephen Sameroff, Shannon Delaney, Gary P. Wormser, Adriana Marques, W. Ian Lipkin,

A B S T R A C T

Borrelia miyamotoi is an emerging tick-borne spirochete transmitted by ixodid ticks. Current serologic assays for B. miyamotoi are impacted by genetic similarities to other Borrelia and limited understanding of optimal antigenic targets. In this study, we employed the TBD-Serochip, a peptide array platform, to identify new linear targets for serologic detection of B. miyamotoi.

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Today’s letter to the corresponding author……

April 9, 2020

Columbia University Mailman School of Public Health
722 West 168th St.
NY, NY 10032
Attn: Rafal Tokarz, PhD, Assistant Professor of Epidemiology

Dear Prof Tokarz,

In reference to the detection of tick-borne disease, please take a moment if you will to review the following list of publications using direct detection methods for identifying ongoing spirochetal infection. I will summarize the purpose of this correspondence at the end of this list:

1. Seronegative Chronic Relapsing Neuroborreliosis.  (Stony Brook Lyme clinic)
https://www.ncbi.nlm.nih.gov/pubmed/7796837

“We report an unusual patient with evidence of Borrelia burgdorferi infection who experienced repeated neurologic relapses despite aggressive antibiotic therapy. Each course of therapy was associated with a Jarisch-Herxheimer-like reaction. Although the patient never had detectable free antibodies to B. burgdorferi in serum or spinal fluid, the CSF was positive on multiple occasions for complexed anti-B. burgdorferi antibodies, B. burgdorferi nucleic acids and free antigen.”

2. Cardiac Tropism of Borrelia burgdorferi: An Autopsy Study of Sudden Cardiac Death Associated with Lyme Carditis.(March 2016)
http://ajp.amjpathol.org/article/S0002-9440(16)00099-7/abstrac

“Fatal Lyme carditis caused by the spirochete Borrelia burgdorferi rarely is identified. Here, we describe the pathologic, immunohistochemical, and molecular findings of five case patients.”

3. CDC Case Study #2: A case report of a 17-year old male with fatal Lyme carditis
https://www.sciencedirect.com/science/article/abs/pii/S1054880715000253

Borrelia burgdorferi was identified via special stains, immunohistochemistry, and polymerase chain reaction. The findings support B. burgdorferi as the causative agent for his fulminant carditis and that the patient suffered fatal Lyme carditis.

4. Granulomatous hepatitis associated with chronic Borrelia burgdorferi infection: a case report
http://www.labome.org/research/Granulomatous-hepatitis-associated-with-chronic-Borrelia-burgdorferi-infection-a-case-report.html

The patient had active, systemic Borrelia burgdorferi infection and consequent Lyme hepatitis, despite antibiotic therapy. Spirochetes were identified as Borrelia burgdorferi by molecular testing with specific DNA probes.

5. Culture evidence of Lyme disease in antibiotic treated patients living in the Southeast.
http://danielcameronmd.com/culture-evidence-of-lyme-disease-in-antibiotic-treated-patients-living-in-the-southeast/

Rudenko and colleagues reported culture confirmation of chronic Lyme disease in 24 patients in North Carolina, Florida, and Georgia. All had undergone previous antibiotic treatment

6. DNA sequencing diagnosis of off-season spirochetemia with low bacterial density in Borrelia burgdorferi and Borrelia miyamotoi infections.
https://www.ncbi.nlm.nih.gov/pubmed/24968274

Faulty/misleading antibody tests landed a sixteen year old male in a psychiatric ward when his lab results did not meet the CDC’s strict criteria for positive results. His Western blot had only four of the required five IgG bands. Subsequent DNA sequencing identified a spirochetemia in this patient’s blood so his psychiatric issues were a result of neurologic Lyme disease misdiagnosed by antiquated/misleading serology. This patient was previously treated with antibiotics.

7. The Long-Term Persistence of Borrelia burgdorferiAntigens and DNA in the Tissues of a Patient with Lyme Disease
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6963883/

Autopsy tissue sections of the brain, heart, kidney, and liver were analyzed by histological and immunohistochemical methods (IHC), confocal microscopy, fluorescent in situ hybridization (FISH), polymerase chain reaction (PCR), and whole-genome sequencing (WGS)/metagenomics. We found significant pathological changes, including borrelial spirochetal clusters, in all of the organs using IHC combined with confocal microscopy.

8. Persistent Borrelia Infection in Patients with Ongoing Symptoms of Lyme Disease
http://www.mdpi.com/2227-9032/6/2/33

“This pilot study recently identified chronic Lyme disease in twelve patients from Canada. All of these patients were culture positive for infection (genital secretions, skin and blood) even after multiple years on antibiotics so there was no relief from current antimicrobials. Some of these patients had taken as many as eleven different types of antibiotics.”

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Note: For the sake of time this is just a short list of the hundreds of publications identifying persistent Borrelia infection.

What is the purpose of this email?

Direct detection methods, specifically DNA testing has the ability to identify persistent infection whereas serology cannot be used to gauge treatment failure or success. Not to mention that humans do not produce antibodies against Borrelia for 4-6 weeks after a tick bite. By the time serology tests are positive, the spirochetes have already invaded various deep tissues, like those in syphilis, and are hard to eradicate with antibiotics.

Serology has allowed the 30-year dogma to persevere [1]whereas direct detection methods are exposing the exact opposite.

We are dealing with a life-altering/life-threatening infection with faulty/misleading antibody tests, inadequate treatment, no medical training and absolutely no disease control whatsoever; a public health disaster.

It is time to utilize 21st century technology for the purpose of rapid detection and efficacy of treatment.

If DNA testing is accepted for the 21st century pandemic (COVID-19) [2] ; why not for the 20th century plague (Lyme disease) that has been allowed to proliferate unchecked?

Respectfully Submitted,

Carl Tuttle
Lyme Endemic Hudson, NH

Cc: The tick-Borne Disease Working Group

References

1. Lyme Disease Is Hard to Catch And Easy to Halt, Study Finds
New York Times By GINA KOLATA Published: June 13, 2001

http://www.nytimes.com/2001/06/13/us/lyme-disease-is-hard-to-catch-and-easy-to-halt-study-finds.html

2. The Science Behind the Test for the COVID-19 Virus

https://discoverysedge.mayo.edu/2020/03/27/the-science-behind-the-test-for-the-covid-19-virus/

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https://www.change.org/p/the-us-senate-calling-for-a-congressional-investigation-of-the-cdc-idsa-and-aldf/u/26339210?

Email to the attention of Dr. Paul Mead, Chief of the CDC Bacterial Diseases Branch

Today’s letter to Paul Mead of the CDC regarding the continued use of serology mentioned in the latest study on Borrelia miyamotoi at the top of the page.

Apr 13, 2020

Division of Vector-Borne Diseases
Centers for Disease Control and Prevention
3156 Rampart Rd
Fort Collins, Colorado CO 80521
Attn: Paul Mead, MD, MPH Acting Branch Chief

pfm0@cdc.gov

Dear Dr. Mead,

In October of 2018 you coauthored the following paper in Clinical Infectious Diseases and made the following statement regarding serologic testing for Lyme disease:

Direct Diagnostic Tests for Lyme Disease

Clinical Infectious Diseases, ciy614, https://doi.org/10.1093/cid/ciy614

Published: 11 October 2018

Excerpt:  (Quote from Paul Mead)

“… serologic tests cannot distinguish active infection, past infection, or reinfection. Reliable direct-detection methods for active B. burgdorferi infection have been lacking in the past but are needed and appear achievable.”

Dr. Mead…. So why is the National Institutes of Health funding Dr. Gary Wormser’s study for the serologic detection of B. miyamotoi?

Obviously Dr. Wormser didn’t get your memo or you are just providing lip service to give the illusion that our public health officials have everything under control.

What is the status of Direct Diagnostic Tests for Lyme Disease Dr. Mead? Persistent infection after extensive antibiotic treatment has been identified through the use of direct detection methods in academic centers and autopsy findings [1]yet the average patient cannot obtain these tests to justify how sick they are with their chronic active infection.

Please provide a list of grants issued by the CDC or National Institutes of Health for studies actively involved in developing Direct Diagnostic Tests for Lyme Disease.

I expect a prompt reply to this inquiry.

Respectfully submitted,

Carl Tuttle

Lyme Endemic Hudson, NH

Reference:

[1] More of the same focus on Serology!

https://www.change.org/p/the-us-senate-calling-for-a-congressional-investigation-of-the-cdc-idsa-and-aldf/u/26304991

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For more on the concerted suppression of direct testing for borrelia:  https://madisonarealymesupportgroup.com/2017/12/13/suppression-of-microscopy-for-lyme-diagnostics-professor-laane/

https://madisonarealymesupportgroup.com/2018/04/03/cdc-deliberately-avoids-direct-detection-testing-methods-for-ld/

https://madisonarealymesupportgroup.com/2018/10/13/direct-test-for-ld-carl-tuttle-chews-up-cdc-spits-them-out/

https://madisonarealymesupportgroup.com/2018/01/16/2-tier-lyme-testing-missed-85-7-of-patients-milford-hospital/

https://madisonarealymesupportgroup.com/2020/03/01/study-cdcs-2-tier-lyme-testing-inaccurate-in-more-than-70-of-cases/

https://madisonarealymesupportgroup.com/2018/08/15/milford-pathologist-fires-broadside-at-cdc-motion-to-discuss/

BTW: The CDC is directly behind the COVID-19 testing fiasco.  This article points out that insisting upon their own tests is the MO of the CDC – even when human lives are at stake:  https://madisonarealymesupportgroup.com/2020/03/27/cdcs-deadly-testing-fiasco-centralization-of-public-health-authority-a-threat-to-national-security/ The reason for this is so they control all the parameters for further products that will make them money – everything from test kits to drugs to vaccines.

The CDC has controlled Lyme testing for decades and it rules like the iron curtain even though research clearly shows it is abysmal and misses at least half of all cases – and often times much more.