News video- Lyme More Common in UK than Thought
Interview with Janey Cringean – Channel 5 News
Lyme Disease is more common in the UK than thought.
July 31, 2019
Archive for the ‘Testing’ Category
FDA Clears New Lyme Test – Which Still Sucks
FDA clears new indications for existing Lyme disease tests that may help streamline diagnoses
U.S. Food and Drug Administration
Jul 29, 2019
SILVER SPRING, Md., July 29, 2019 /PRNewswire/ — Today, the U.S. Food and Drug Administration cleared for marketing four previously cleared tests with new indications to aid in the diagnosis of Lyme disease. The tests cleared today are the first time that a test has been indicated to follow a new testing paradigm in which two tests called enzyme immunoassays (EIA) are run concurrently or sequentially, rather than the current two-step process in which a separate protein test called a Western Blot must be run after the initial EIA test.
“Lyme disease can have a devastating impact on patients. With today’s action, clinicians have a new option to test for Lyme that is easier to interpret by a clinical laboratory due to the streamlined method of conducting the test. These tests may improve confidence in diagnosing a patient for a condition that requires the earliest possible treatment to ensure the best outcome for patients,” said Tim Stenzel, M.D., Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health.
Lyme disease is caused by the bacteria Borrelia burgdorferi and is transmitted to humans through the bite of infected ticks. Typical symptoms include fever, headache, fatigue and skin rash called erythema migrans. If left untreated, infection can spread to joints, the heart and the nervous system. In 2017, the last year for which the Centers for Disease Control and Prevention (CDC) has published data, a total of 42,743 confirmed and probable cases of Lyme disease were reported to CDC, an increase of 17% from 2016.
Laboratory diagnosis of Lyme disease has traditionally used a two-tier process for detecting the presence of antibodies against Borrelia burgdorferi in a patient’s blood. Antibodies are proteins present in the blood when the body is responding to a specific infection. In the previous two-tier approach, different types of tests were used (EIA and Western blots) to confirm a clinical diagnosis. The tests cleared today involve a modified approach that uses only EIA technology-based tests.
The FDA reviewed data from clinical studies of the ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System, ZEUS ELISA Borrelia burgdorferi IgG/IgM Test System, ZEUS ELISA Borrelia burgdorferi IgM Test System, and the ZEUS ELISA Borrelia burgdorferi IgG Test System that showed this alternative approach, referred to as a modified two-tier test, is as accurate as current methods for detecting antibodies for assessing exposure to Borrelia burgdorferi, the causative agent of Lyme disease, over current methods.
CDC recommendations should be followed for the diagnosis of Lyme disease and for determining when laboratory tests are appropriate.
The enzyme immunoassay tests were reviewed through the premarket notification (510(k)) pathway. A 510(k) is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device.
The FDA granted clearance of the ZEUS ELISA enzyme immunoassay tests to ZEUS Scientific.
More information:
FDA: Ticks and Lyme Disease: Symptoms, Treatment, and Prevention
FDA: Premarket Clearances
CDC: Lyme disease
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
Media Inquiries: Stephanie Caccomo, 301-348-1956, stephanie.caccomo@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
SOURCE U.S. Food and Drug Administration
According to LDA President Pat Smith,
“It appears the new two-tier system is being offered as an alternative to the existing two-tier. Whether it will prove out to be as accurate as the current system remains to be seen. Since the current two tier system is considered to be about 50% accurate by many, and many treating physicians feel the Western Blot is perhaps the most significant portion of that system, it is hard to say what impact this new system without the WB will have on diagnosis. The fact that the tests can be run concurrently could mean less delay in testing to diagnosis/treatment time for some individuals. However, at this point, we do not know enough about the tests to make any further assessments, although it is not the new technology many have hoped for in a new testing paradigm.”
_________________
**Comment**
Question: why replace an old worthless 2-tiered test with a new one?
Please note: “modified two-tier test, is AS ACCURATE as current methods for detecting antibodies for assessing exposure to Borrelia burgdorferi…”
The current methods aren’t accurate.
This is a complete joke.
Abysmal blood serology which tests for antibodies still stinks since many will never mount an immune response. Again, some of the sickest patients will NEVER test positive on this type of testing. While Western Blots appear to be better, setting arbitrary levels set by people with conflicts of interests is still a problem.
Lyme/MSIDS is STILL a clinical diagnosis. There is nothing easy about this and it takes education, experience, and savvy. Until practitioners man-up and become educated on symptomology, patients are doomed.
The only possible positive is that this horrific, inaccurate process is faster. In other words, you will find out you don’t have Lyme quicker than before – when in fact you very well could be infected.
https://www.ncbi.nlm.nih.gov/pubmed/21040573
Two-tiered testing missed 85.7% of the walk-in patients in the Emergency Room of Milford Hospital.
This test will also NEVER show coinfections. It’s a singular test for a polymicrobial disease:
Coinfection of Many Types of Borrelia, Rickettsia, Babesia, Bartonella, & Anaplasma in French Castor Bean Ticks
https://www.ncbi.nlm.nih.gov/pubmed/31279737/
Ticks Tick Borne Dis. 2019 Jun 8. pii: S1877-959X(18)30483-7. doi: 10.1016/j.ttbdis.2019.06.001. [Epub ahead of print]
Co-infection of bacteria and protozoan parasites in Ixodes ricinus nymphs collected in the Alsace region, France.
Abstract
Fifty nymphal Ixodes ricinus ticks collected in Alsace, France, identified by morphological criteria and using MALDI-TOF MS, were tested by PCR to detect tick-associated bacteria and protozoan parasites. Seventy percent (35/50) of ticks contained at least one microorganism; 26% (9/35) contained two or more species. Several human pathogens were identified including Borrelia burgdorferi s.s. (4%), Borrelia afzelii (2%), Borrelia garinii (2%), Borrelia valaisiana (4%), Borrelia miyamotoi (2%), Rickettsia helvetica (6%) and “Babesia venatorum” (2%). Bartonella spp. (10%) and a Wolbachia spp. (8%) were also detected. The most common co-infections involved Anaplasmataceae with Borrelia spp. (4%), Anaplasmataceae with Bartonella spp. (6%) and Anaplasmataceae with Rickettsia spp. (6%). Co-infection involving three different groups of bacteria was seen between bacteria of the family Anaplasmataceae, Borrelia spp. and Bartonella spp. (2%). Results highlight the panel of infectious agents carried by Ixodes ricinus. Co-infection suggests the possibility of transmission of more than one pathogen to human and animals during tick blood feeding.
_________________
**Comment**
Ixodes ricinus, commonly known as the castor bean tick, sheep tick, or deer tick, transmits numerous pathogens of medical and veterinary importance including Borrelia burgdorferi s.l. causing Lyme borreliosis, tick-borne encephalitis virus, Anaplasma phagocytophilum causing human granulocytic ehrlichiosis, Francisella tularensis causing Tularaemia, Rickettsia helvetica and Rickettsia monacensis, Babesia divergens and Babesia microti responsible for Babesiosis, Louping ill virus and Tribec virus. https://ecdc.europa.eu/en/disease-vectors/facts/tick-factsheets/ixodes-ricinus
https://madisonarealymesupportgroup.com/2019/04/26/three-strains-of-borrelia-other-pathogens-found-in-salivary-glands-of-ixodes-ticks-suggesting-quicker-transmission-time/ Numerous pathogens identified plus the fact many were located IN the tick’s salivary glands indicating faster transmission time for infection.
For decades we’ve been told by the CDC that it takes a minimum of 36-48-hours for a tick to transmit Lyme to a human. Then, in 2013 we were told they needed to be embedded for 24 hours or more: https://www.nhregister.com/columns/article/DR-KATZ-Of-Lyme-disease-and-lemonade-11412658.php
Then, microbiologist Holly Ahern came out with a fantastic video revealing that research on minimum attachment times have NEVER been done: https://madisonarealymesupportgroup.com/2017/04/14/transmission-time-for-lymemsids-infection/
Transmission Time: Only one study done on Mice. At 24 hours every tick had transmitted borrelia to the mice; however, animal studies have proven that transmission can occur in under 16 hours and it occurs frequently in under 24 hours. No human studies have been done and https://www.dovepress.com/lyme-borreliosis-a-review-of-data-on-transmission-time-after-tick-atta-peer-reviewed-article-IJGM no studies have determined the minimum time it takes for transmission.
YET, “AUTHORITIES” CONTINUE TO PROPAGATE THIS LONGER WINDOW, DESPITE LYME/MSIDS BEING A TRUE 21ST CENTURY PANDEMIC & PLAGUE.
This study once again supports the fact that patients are often coinfected with many pathogens transmitted from the same tick and that the CDC/IDSA myopic viewpoint of a singular disease is a joke that the mono-therapy of doxycycline won’t touch in a million years: https://madisonarealymesupportgroup.com/2018/10/30/study-shows-lyme-msids-patients-infected-with-many-pathogens-and-explains-why-we-are-so-sick/
Avoiding Direct Detection Methods For the Purpose of Concealing Chronic Lyme Disease Is A Crime
Avoiding direct detection methods for the purpose of concealing chronic Lyme disease is a crime
JUL 19, 2019 —
The letter below from Dr. Paul Auwaerter (Past president of the IDSA) is third in a series of correspondence over my request for proficiency testing for Nested PCR And DNA Sequencing For The Detection Of Lyme Disease And Related Borreliosis; the direct detection of the spirochete causing Lyme disease. Previous communication can be reviewed in recent Petition Updates.
The real reason the CDC stopped communication with Drs Lee and Shearer is because they published a case of chronic Lyme where a so-called Lyme disease specialist condemned a sixteen year old to a psychiatric ward because his Western blot only had 4 out of the 5 IgG bands required for positive test result. It is no secret that the US Centers for Disease Control is in bed with the IDSA.
Lyme Bumper Stickers (Public Service Announcement)
https://www.ebay.com/itm/123659578861
WAKE UP AMERICA!
Today’s letter to the Tick-borne Disease Working Group……
——— Original Message ———-
From: CARL TUTTLE <runagain@comcast.net>
To: tickbornedisease@hhs.gov, chris.smith@mail.house.gov
Cc:(98 Undisclosed recipients)
Date: July 19, 2019 at 9:16 AM
Subject: Re: Lyme disease often misdiagnosed, resulting in unnecessary antibiotics
To the Tick-Borne Disease Working Group,
Please see the final response from Dr. Paul Auwaerter who is not interested in proficiency testing for direct detection of Lyme disease. My reply to Dr. Auwaerter immediately follows his note below:
Response from Dr. Paul Auwaerter:
——— Original Message ———-
From: Paul Auwaerter <pauwaert@jhmi.edu>
To: CARL TUTTLE <runagain@comcast.net>
Cc: psax@bwh.harvard.edu, jli@bwh.harvard.edu, cbusky@idsociety.org, Takaaki Kobayashi <tkobayashi@jhmi.edu>, jmstiglich@healio.com, infectiousdisease@healio.com
Date: July 18, 2019 at 9:23 PM
Subject: RE: Lyme disease often misdiagnosed, resulting in unnecessary antibiotics
Dear Mr. Tuttle,
I’d like to close our correspondence to make clear the Foundation doesn’t have funds currently to entertain your specific area of research. You may get a sense of the funding priorities of the IDSA Foundation from our website; however, if philanthropic funds are made available with disease-specific areas, the IDSAF would entertain such research funding.
I have read your other concerns with our paper and approach, and I do hear your disagreement.
Sincerely,
Paul Auwaerter MD
Vice-Chair, IDSA Foundation
__________________________________
Carl Tuttle’s reply to Dr. Auwaerter:
———- Original Message ———-
From: CARL TUTTLE <runagain@comcast.net>
To: Paul Auwaerter <pauwaert@jhmi.edu>
Cc: psax@bwh.harvard.edu, jli@bwh.harvard.edu, cbusky@idsociety.org, Takaaki Kobayashi <tkobayashi@jhmi.edu>, jmstiglich@healio.com, infectiousdisease@healio.com
Date: July 19, 2019 at 8:58 AM
Subject: RE: Lyme disease often misdiagnosed, resulting in unnecessary antibiotics
Dear Dr. Auwaerter,
In conclusion of our correspondence I would like to offer the following publication:
DNA sequencing diagnosis of off-season spirochetemia with low bacterial density in Borrelia burgdorferi and Borrelia miyamotoi infections.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4139787/
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.
Current antibody tests for Lyme disease cannot be used to gauge treatment failure or success which makes them the ideal tool for concealing persistent infection.
I want to make this perfectly clear Dr. Auwaerter; avoiding direct detection methods for the purpose of concealing chronic Lyme disease is a crime.
Sincerely,
Carl Tuttle
Lyme Endemic Hudson, NH
__________________
**Comment**
This unfortunate story of someone being admitted to the psych ward due to not testing “positive enough” is only one of thousands…
This has been going on for over 40 years all over the world.
I’ve posted this before, but it bears repeating: https://madisonarealymesupportgroup.com/2017/07/09/idsa-founder-used-potent-iv-antibiotics-for-chronic-lyme/
“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.” Dr. Waisbren
Horrific antibody testing has been dooming patients for literally 4 decades. Time for change.
https://madisonarealymesupportgroup.com/2018/09/12/lyme-testing-problems-solutions/
Human Seroprevalence of Tick-Borne Anaplasma, Lyme, and Rickettsia Species in Northern California
https://www.ncbi.nlm.nih.gov/pubmed/31295054/
Vector Borne Zoonotic Dis. 2019 Jul 11. doi: 10.1089/vbz.2019.2489. [Epub ahead of print]
Human Seroprevalence of Tick-Borne Anaplasma phagocytophilum, Borrelia burgdorferi, and Rickettsia Species in Northern California.
Pascoe EL1, Stephenson N1, Abigana A1, Clifford D1,2, Gabriel M3, Wengert G3, Brown R4, Higley M5, Bloch EM6, Foley JE1.
Abstract
There is a paucity of data on human exposure to tick-borne pathogens in the western United States. This study reports prevalence of antibodies against three clinically important tick-borne pathogens (Borrelia burgdorferi, Anaplasma phagocytophilum, and Rickettsia spp.) among 249 people in five counties in northern California. Individuals from Humboldt County were recruited and answered a questionnaire to assess risk of exposure to tick-borne pathogens. Samples from other counties were obtained from a blood bank and were anonymized. Seventeen (6.8%) samples were seropositive for antibodies against at least one pathogen: five for A. phagocytophilum, eight for B. burgdorferi, and four for Rickettsia spp. Women and people aged 26-35 had higher seroprevalence compared to other demographic groups. Santa Cruz County had no seropositive individuals, northern Central Valley counties had three seropositive individuals (all against A. phagocytophilum), and Humboldt County had 14 (all three pathogens), a significant, four-fold elevated risk of exposure. The Humboldt County questionnaire revealed that a bird feeder in the yard was statistically associated with exposure to ticks, and lifetime number of tick bites was associated with increasing age, time watching wildlife, and time hiking. Three-quarters of respondents were concerned about tick-associated disease, 81.0% reported experiencing tick bites, and 39.0% of those bitten reported a tick-borne disease symptom, including skin lesions (76.4%), muscle aches (49.1%), joint pain (25.5%), or fever (23.6%).
Despite high levels of concern, many individuals who had been bitten by a tick were not tested for a tick-borne pathogen, including those with consistent symptoms.
We highlight the need for further research and dissemination of information to residents and physicians in Northern California regarding tick-associated disease, so that appropriate medical attention can be rapidly sought and administered.
________________
**Comment**
Again, the numbers are going to be much higher as they used the abysmal serology testing which tests for antibodies – not the organisms.
More on California: https://madisonarealymesupportgroup.com/2018/05/24/lyme-in-california-what-you-need-to-know/
https://madisonarealymesupportgroup.com/2018/05/19/infected-ticks-in-california-its-complicated/
https://madisonarealymesupportgroup.com/2017/08/07/california-lyme-cases-get-no-respect/
https://madisonarealymesupportgroup.com/2018/02/02/miyamotoi-in-ixodes-pacificus-in-california/
https://madisonarealymesupportgroup.com/2018/02/15/b-miyamotoi-in-ca-ticks-for-a-long-time/
https://madisonarealymesupportgroup.com/2017/10/09/bb-in-california-chipmunk-and-squirrels/
https://madisonarealymesupportgroup.com/2019/05/26/educating-california-about-lyme-disease/
Madison Area Lyme Support Group 