Archive for the ‘Testing’ Category

Developing New Tests to Identify ALL Bacteria in Ticks – Drexel University

https://www.lymedisease.org/drexel-new-tick-testing/

LYME SCI: Developing new tests to identify ALL bacteria in ticks

by Lonnie Marcum

Researchers at Philadelphia’s Drexel University College of Medicine have joined the fight against tick-borne diseases and are asking citizens throughout the US to send them ticks.

Drexel’s Center for Advanced Microbial Processing (CAMP) has developed a state-of-the-art facility using comprehensive high-resolution testing able to detect all bacteria inside of ticks—not just Lyme disease and its better-known co-infections.

The goal of CAMP is to identify emerging pathogens and use that information to find targeted therapies to cure infection and illness.

Garth Ehrlich, PhD, holds professorships in two departments at Drexel—Microbiology & Immunology, and Otolaryngology. He’s also Executive Director of CAMP. He first thought of testing ticks while working on a different project a couple years ago.

Dr. Ehrlich knew about Lyme disease at the time, and started thinking his “Pan Domain Test” might be useful to identify the many different bacteria that are carried by ticks. After looking further, he realized most tick testing done in the past was limited to just a few common pathogens.

The Pan Domain test is unique. It uses “next-generation sequencing” to look for specific genetic markers and is able to detect every bacterium known to science—in just one test. This is different from PCR or ELISA testing, which require a separate test for each suspected pathogen.

In the end, Dr. Ehrlich hopes to have a comprehensive picture of exactly what diseases are carried by ticks in the U.S. Along the same lines, a recent study in France found that 45% of ticks carried five different pathogens. See:  https://www.lymedisease.org/lyme-sci-coinfections/

Current tick testing at CAMP is only set up to detect bacteria. The second phase of the study will look for parasites and fungi found in the same ticks. At this time, the researchers want as many ticks as they can get from diverse parts of the country. This information will give a clearer picture of which tick-borne diseases are the biggest risks in different regions.

Dr. Ehrlich’s goal is to bring the test to the public for human testing. He says that if all goes as planned, the bacterial assay could be available in 2018, with the parasite/fungi test about three to six months behind that. He estimates that his Pan Domain testing will cost significantly less than traditional testing for each pathogen. Not only is it cheaper, but the Pan Domain test can detect emerging bacteria, for which there currently are no standard tests.

I talked to Dr. Jaroslaw (Jarek) Krol when I was at ILADS in November. Jarek is the lab manager for CAMP and is deeply involved in the development of the genetic sequencing and analysis of the tick-testing project. He told me that preliminary tick testing has detected up to 60 different bacteria in northeastern ticks. Since co-infections compound illness and complicate treatment, the ability to rapidly detect many infections at once would be invaluable.

Dr. Krol says ticks can be sent in dead or alive. However, if you are going to send in more than one tick, please bag them separately. Ticks can share germs, he says, which can skew test results.

Click here to download the instructions and form for sending your ticks to CAMP:  http://drexel.edu/medicine/about/departments/institute-for-molecular-medicine-infectious-disease/Research-Centers-of-Excellence/center-for-advanced-microbial-processing/microbiome-testing-on-ticks/

Important note: CAMP testing is for research only. You will not be sent results of the testing. If you have been bitten by a tick and want to know what pathogens you were exposed to, you can send it to the University of Massachusetts’ TickReport. You should receive results within three business days.  https://www.tickreport.com

LymeSci is written by Lonnie Marcum, a Licensed Physical Therapist and mother of a daughter with Lyme. Follow her on Twitter: @LonnieRhea Email her at: lmarcum@lymedisease.org.

 

New Lyme Tests Could Offer Quicker, More Accurate Detection

https://news.rutgers.edu/new-lyme-disease-tests-could-offer-quicker-more-accurate-detection/20171206#.WlzTVug-c2Y

New Lyme Disease Tests Could Offer Quicker, More Accurate Detection

Updated methods would help doctors decide when to prescribe the antibiotics used to clear the infection and help avoid severe long-term health problems
New tests are at hand that offer more accurate, less ambiguous test results that can yield actionable results in a timely fashion.
“Improved tests will allow for earlier diagnosis, which should improve patient outcomes.” – Steven Schutzer
 New tests to detect early Lyme disease – which is increasing beyond the summer months – could replace existing tests that often do not clearly identify the infection before health problems occur.

In an analysis published on December 7 in Clinical Infectious Diseases, scientists from Rutgers University, Harvard University, Yale University, the National Institute of Allergy and Infectious Diseases of the National Institutes of Health and other academic centers, industry and public health agencies say new diagnostic methods offer a better chance for more accurate detection of the infection from the Lyme bacteria.

“New tests are at hand that offer more accurate, less ambiguous test results that can yield actionable results in a timely fashion,” said Steven Schutzer, a physician-scientist at Rutgers New Jersey Medical School and senior author. “Improved tests will allow for earlier diagnosis, which should improve patient outcomes.”

Lyme disease is the most common tick-borne infection in North America and Europe. There are currently over 300,000 cases of Lyme disease annually in the United States alone, and the disease is increasing and spreading into new regions. Lyme disease frequently, but not always, presents with a bull’s-eye rash. When the rash is absent, a laboratory test is needed.

The only FDA-approved Lyme disease tests, based on technology developed more than two decades ago, rely on detecting antibodies that the body’s immune system makes in response to the disease. These antibody-based tests are the most commonly used tests for Lyme disease and are the current standard.

Lyme disease rash
Lyme disease frequently, but not always, presents with a bull’s-eye rash. When the rash is absent, a laboratory test is needed.
One problem, however, is that many people produce similar – called “cross-reactive” – antibodies in response to other bacteria not associated with Lyme disease, which causes confusing results and makes test accuracy more difficult.

“New tests are more exact and are not as susceptible to the same false-positive or false-negative results associated with current tests.” said Schutzer.

Schutzer and his colleagues say more accurate testing would help doctors decide when to prescribe the antibiotics used to clear the infection and help avoid severe long-term health problems. Antibody tests, can take three weeks or more for the antibody levels to reach a point where the tests can pick up a positive result.

Those involved in the paper joined forces after meeting at Cold Spring Harbor Laboratory’s Banbury Center, a nonprofit research institution in New York.  The meeting organized and chaired by Schutzer and John A. Branda, assistant professor of pathology at Harvard Medical School, focused on current Lyme disease tests and new scientific advances made in increasing the accuracy of the diagnosis.

“This meeting and paper resulting from it are particularly significant,” said Jan Witkowski, professor in the Watson School of Biological Sciences at Cold Spring Harbor Laboratory who along with Nobel Laureate James Watson asked Schutzer to lead several symposia. “The participants noted that there are greatly improved diagnostic tests for Lyme disease that can be implemented now, and that the way is open to the development of further tests.”

______________

**Comment**

The article fails to mention these “better tests” and the abstract fails to do so as well, except to say that next-generation serodiagnostic testing, focusing on methods that are currently available or near-at-hand, can now overcome or circumvent many of the past drawbacks.  Abstract found here:  https://academic.oup.com/cid/advance-article-abstract/doi/10.1093/cid/cix943/4706288?redirectedFrom=fulltext

Those of us in Lyme-land have known for decades that better testing is available, it’s just mainstream medicine refuses to use them.  I know of a patient who after testing negative on the CDC two-tiered testing, went to a Lyme literate doctor who used the extended Western Blot from IgeneX and tested positive.  When she showed up with proof in hand, the regular doctor announced that test was faulty, threw it into the trash, and then without permission, retested her again with the CDC two-tier testing.  When the patient showed up at a follow-up appointment, the doctor smugly announced she did not have Lyme because the second CDC test was again negative.

This is the type of thing Lyme/MSID patients are used to and what we advocates warn folks of.  Do not expect a regular doctor, at this point in time, to embrace any testing methods other than the CDC two-tiered testing.  They will even tell you they are FDA-approved which is only half the story.  The FDA does not require approval for labs that do not sell test kits (such as IGeneX).  There are all sorts of laboratory standards and IGeneX is a CLIA-certified high complexity testing lab with on site inspections by state and federal inspectors every two years in states that have the most stringent lab requirements (New York, and California).  They are a small lab specializing in bacteriology and virology – not a monopoly that tests for everything from staph to strep.

Go here for IGeneX accreditations, certifications, and licenses:  https://www.igenex.com/why-igenex/licenses-accreditations/  You can print these out and attempt to show your general GP; however, I wouldn’t hold my breath despite the concrete evidence.

Rivoting here a moment, I remember attending a public forum at the WI capital where a pediatric doctor called the IGeneX test, “Home brewed,” obviously deriving that particular wording from here:  https://www.igenex.com/why-igenex/licenses-accreditations/

I assure you, CLIA has tough standards and would not allow a lab to exist if it didn’t cut the muster.  The problem, once again, is that doctors are woefully uneducated and fall back on quick articles like these to pass judgement, rather than studying the issue for themselves.  This lack of due diligence has unfortunately affected thousands of people who are sent home and denied treatment due to a negative test.  

Lyme patients and advocates have been screaming bloody murder for years over the conflicts of interest and CDC testing monopoly.  Go here for the sordid story:  https://crymedisease.wordpress.com/2016/02/28/the-conspirators-they-own-the-patents-and-changed-the-testing/   (spoiler alert – they own the patents to the tests)

http://truthbetoldx81.blogspot.com/2017/06/biggest-medical-fraud-in-history-of.html

https://on-lyme.org/en/sufferers/lyme-stories/item/261-unprecedented-claim-against-the-cdc-over-lyme-tests   The CDC commitment to the national study abruptly stopped with no reasons given. However, it appears the CDC is focusing on developing their own newly patented test rather than supporting a group of innovators that compete with the CDC patents.

https://madisonarealymesupportgroup.com/wp-content/uploads/2018/01/09bc3-uos2_claim_references_2.pdf  The CDC denies patent holding despite it being right here in purple crayon.

In conclusion and purposely focusing on the silver lining, this article will hopefully poke the scientific world from its 40 year nap and be a reminder that the outcome of the most prevalent vector-borne disease on the planet has been stymied by a lack of diagnostic testing and that more accurate testing is required.  

Hopefully it will also begin the breakup of the love-affair the CDC has for two-tiered testing.

For more on testing:

https://www.lymedisease.org/lyme-basics/lyme-disease/diagnosis/

https://madisonarealymesupportgroup.com/2016/12/07/igenex-presentation/

https://madisonarealymesupportgroup.com/2017/10/17/igenex-introduces-3-new-lyme-tests/

https://madisonarealymesupportgroup.com/2017/08/15/reliability-of-lyme-testing/

https://madisonarealymesupportgroup.com/2017/04/12/comparing-lyme-testing-with-hiv-testing/

Diagnosis and Management of Lyme Neuroborreliosis

https://www.ncbi.nlm.nih.gov/m/pubmed/29278020/

Diagnosis and management of Lyme neuroborreliosis.

Halperin JJ. Expert Rev Anti Infect Ther. 2018.

Abstract

The nervous system is involved in 10-15% of patients infected with B. burgdorferi, B. afzelii and B. garinii. This review will address widespread misconceptions about the clinical phenomenology, diagnostic approach and response to treatment of neuroborreliosis. Areas covered: Improvements in diagnostic testing have allowed better definition of the clinical spectrum of neuroborreliosis, with lymphocytic meningitis and uni- or multifocal inflammation of peripheral/cranial nerves predominating. Despite widespread concern that post-treatment cognitive/behavioral symptoms might be attributable to persisting infection or aberrant inflammation within the central nervous system a large body of evidence indicates this is extremely improbable. Importantly, recent studies show most neuroborreliosis can be treated with fairly brief courses of oral antibiotics. All high-level evidence confirms that prolonged courses of antibiotics carry harm with no commensurate benefit. Expert commentary: Lyme disease in the US, and corresponding disorders in Europe, are well defined neuro-infectious diseases that are highly responsive to antibiotic therapy. Although the nervous system is slow to recover after insults (e.g. persistent facial weakness after appropriately treated facial nerve palsy) there is no evidence that prolonged post-treatment neurocognitive symptoms are related to nervous system infection – either as a triggering event or as a cause of ongoing symptoms.

 _____________

**Comment**

While I would love to read this in its entirety for amusement, I refuse to pay $1 let alone $90 for 24 hour access.

Just from the abstract it is evident that it is another great example of why a medical condition never makes forward progress.  “Experts” like Halperin refuse to rethink the paradigm.

  • This article focuses only on borrelia, a formidable foe alone, an absolute shape-shifting beast on steroids when coupled with Babesia, Bartonella, Anaplasma, and other critters.  The one disease, one drug paradigm needs to go straight into the garbage can, and until this happens we are doomed.
  • The 10-15% patient statistic with nervous system involvement also needs to go straight into the can.  Nobody has a clue on numbers on any of this.  If the CDC goes from 30,000 new cases to over 300,000 new cases a year, I think we need to wave the white flag and admit our ignorance.
  • Without reading the entire faulty article, I have a deep rooted suspicion that this “review” is based on other deeply flawed articles and studies from the past made by the Cabal.  https://madisonarealymesupportgroup.com/2017/01/13/lyme-science-owned-by-good-ol-boys/ and https://madisonarealymesupportgroup.com/2017/12/06/ahern-flawed-lyme-policies-diagnostics-and-treatment/
  • Diagnostic testing has not improved with the CDC even stating numerous tests might be needed:  https://madisonarealymesupportgroup.com/2017/07/01/good-morning-america-cdc-advises-multiple-lyme-tests-due-to-false-negative-results/
  • A recent study states that treating prophylactically if TBI’s are suspected is warranted: https://madisonarealymesupportgroup.com/2017/07/12/start-treatment-if-tbis-are-suspected/.  Also see:  https://www.lymedisease.org/lyme-basics/lyme-disease/diagnosis/, and https://madisonarealymesupportgroup.com/2017/09/02/microbiologist-holly-ahern-on-lyme-disease-how-did-we-get-here/.
  • The definition of the clinical spectrum of neuroborreliosis is not better.  While it is true that more is being reported on, there is absolutely no consensus on any sort of definition.
  • The persisting infection/aberrant inflammation issue is not over just because Halperin reviews old Cabal manuscripts and claims there is a “wide body of evidence.”  As they say, Garbage in, garbage out.
  • Brief courses of antibiotics do work for some people, typically acute cases; however, there is much to indicate that many relapse and continue to have symptoms.  To say otherwise indicates bias of the highest sort.
  • His usage of “high-level evidence” also indicates an extreme personal bias indicating that the rest of us poor fools have low-level evidence.  Please, I know a slam when I hear one.  Nobody in Lyme-land is arguing that antibiotics do not have risks.  Many if not most treatments have risks, including drinking water; however, as with any disease state, the doctor and patient must discuss and weigh the risk/benefit ratio for sure.  An IDSA Founder, Dr. Waisbren, successfully used high powered IV antibiotics and wrote a book on 51 tough cases.  All improved.  https://madisonarealymesupportgroup.com/2017/07/09/idsa-founder-used-potent-iv-antibiotics-for-chronic-lyme/  Again, there are so few studies looking at long-term antibiotic benefit on Lyme/MSIDS that this statement is premature and misleading.  I work with people on a daily basis who state they wouldn’t be alive today without the very treatment he is slamming, and trust me, we would all love an effective treatment with fewer risks!  
  • The “expert commentary” is only expert in my opinion if it takes into account numerous physicians who have actually treated complicated Lyme/MSIDS cases over decades of time, who are open-minded, are willing to change, and are continually studying, listening and learning from others.  Halperin fails on many accounts.  Keep reading below to see why.
  • This review is nothing more than a regurgitation of ancient, unscientific, and biased opinion.

In this interview  Halperin repeats the common myth that Lyme takes 24-49 hours or more to be transmitted  https://madisonarealymesupportgroup.com/2017/04/14/transmission-time-for-lymemsids-infection/, that it is primarily an Eastern problem  http://steveclarknd.com/wp-content/uploads/2013/11/The-Confounding-Debate-Over-Lyme-Disease-in-the-South-DiscoverMagazine.com_.pdf (go to page 6 and read about Speilman’s maps which were faulty but have ruled like the Iron Curtain), and that you typically have flu-like symptoms https://madisonarealymesupportgroup.com/2017/02/24/pcos-lyme-my-story/ (My initial symptoms were gynecological).  He treats everyone with 2-4 weeks of antibiotics.

A quick search reveals Halperin commonly serves as an “expert” witness in medical malpractice cases defending physicians accused of failing to diagnose Lyme.  

Here’s a lengthy article Article Kicking and LLMDs Personal View coauthored by Halperin which states,

“Advocacy for LD has become an increasingly important part of an anti science movement that denies both the viral cause of AIDS and the benefits of vaccines and that supports unproven (sometimes dangerous) alternative medical treatments.”  

Oh, and somehow patients, advocates, and their doctors pose a threat to public health.

 Here’s a few telling Halperin quotes:
QUOTE-  “When physicians who diagnose chronic Lyme disease obtain laboratory tests to provide support for their diagnoses, they often rely heavily on “Lyme specialty laboratories.” Such laboratories may perform unvalidated in-house tests that are not regulated by the Food and Drug Administration, or they may perform standard serologic tests interpreted with the use of criteria that are not evidence-based.1” Source
 
QUOTE-  “Antibiotic therapy can cause considerable harm to patients treated for chronic Lyme disease or post–Lyme disease symptoms.” Source
 
QUOTE-  “Although anecdotal evidence and findings from uncontrolled studies have been used to provide support for long-term treatment of chronic Lyme disease,18-20 a response to treatment alone is neither a reliable indicator that the diagnosis is accurate nor proof of an antimicrobial effect of treatment.” Source
 
QUOTE-  “It is highly unlikely that post–Lyme disease syndrome is a consequence of occult infection of the central nervous system.” Source

TBRF in Texan Dogs – Yep: Despite Poor Tests it’s There

Serological detection of Tick-Borne Relapsing Fever in Texan domestic dogs

Esteve-Gasent MD, Snell CB, Adetunji SA, Piccione J.
/PLoS One/. 2017 Dec 12;12(12):e0189786. eCollection 2017.

https://doi.org/10.1371/journal.pone.0189786

Abstract

Tick-Borne Relapsing Fever (TBRF) is caused by spirochetes in the genus
/Borrelia/. Very limited information exists on the incidence of this
disease in humans and domestic dogs in the United States. The main
objective of this study is to evaluate exposure of dogs to /Borrelia
turicatae/, a causative agent of TBRF, in Texas.

To this end, 878 canine serum samples were submitted to Texas A&M
Veterinary Medical Diagnostic Laboratory from October 2011 to September
2012 for suspected tick-borne illnesses. The recombinant Borrelial
antigen glycerophosphodiester phosphodiesterase (GlpQ) was expressed,
purified, and used as a diagnostic antigen in both ELISA assays and
Immunoblot analysis. Unfortunately, due to significant background
reaction, the use of GlpQ as a diagnostic marker in the ELISA assay was
not effective in discriminating dogs exposed to /B/. /turicatae/.
Nevertheless, immunoblot assays showed that 17 out of 853 samples tested
were considered to be seropositive, which constitutes 1.99% of all Texas
samples tested in this study.

The majority of positive samples were from central and southern Texas.
Exposure to TBRF spirochetes may be seasonal, with 70.59% (12 out of 17)
of the cases detected between June and December. In addition, 2 out of
the 17 sero-reactive cases (11.76%) showed reactivity to both /B/.
/burgdorferi/ (causative agent of Lyme disease) and /B/. /turicatae/ (a
causative agent of TBRF).

This is the first report of TBRF sero-prevalence in companion animals in
an endemic area. Our findings further indicate that /B/. /turicatae/ is
maintained in domestic canids in Texas in regions where human disease
also occurs, suggesting that domestic dogs could serve as sentinels for
this disease.

______________

**Comment**

I predict much more to come.  Texan Lyme/MSIDS patients – we stand with you.

For a must-read important history about the South’s fight to be recognized as having tick borne illness:  https://madisonarealymesupportgroup.com/2017/10/06/remembering-dr-masters-the-rebel-for-lyme-patients-who-took-on-the-cdc-single-handedly/

People in the South are commonly denied treatment:  https://madisonarealymesupportgroup.com/2016/09/24/arkansas-kids-denied-lyme-treatment/

https://madisonarealymesupportgroup.com/2017/10/24/no-lyme-in-oklahoma-yeah-right/

And Texans have had enough of the denial and are taking action:  https://madisonarealymesupportgroup.com/2017/11/15/lyme-patients-file-lawsuit-against-idsa-and-insurers-over-treatment-denials/

“Remember the Alamo!”

https://madisonarealymesupportgroup.com/2017/03/09/remember-vicki-logan/

 

LDo’s Top 10 Lyme Research Questions

https://www.lymedisease.org/top-ten-lyme-priorities/

Top-Ten-Research-Questions-with-MLD-logo-1024x625

Press release:

LymeDisease.org releases “Top 10 Lyme Disease Research Questions,” as federal government weighs options in fight against growing epidemic.