Archive for the ‘Testing’ Category

Bbsl Infected Ticks in Canadian Songbirds

https://www.ncbi.nlm.nih.gov/m/pubmed/30044388/

Far-Reaching Dispersal of Borrelia burgdorferi Sensu Lato-Infected Blacklegged Ticks by Migratory Songbirds in Canada.

Scott JD, et al. Healthcare (Basel). 2018.

Abstract

Lyme disease has been documented in northern areas of Canada, but the source of the etiological bacterium, Borrelia burgdorferi sensu lato (Bbsl) has been in doubt. We collected 87 ticks from 44 songbirds during 2017, and 24 (39%) of 62 nymphs of the blacklegged tick, Ixodes scapularis, were positive for Bbsl. We provide the first report of Bbsl-infected, songbird-transported I. scapularis in Cape Breton, Nova Scotia; Newfoundland and Labrador; north-central Manitoba, and Alberta. Notably, we report the northernmost account of Bbsl-infected ticks parasitizing a bird in Canada. DNA extraction, PCR amplification, and DNA sequencing reveal that these Bbsl amplicons belong to Borrelia burgdorferi sensu stricto (Bbss), which is pathogenic to humans. Based on our findings, health-care providers should be aware that migratory songbirds widely disperse B. burgdorferi-infected I. scapularis in Canada’s North, and local residents do not have to visit an endemic area to contract Lyme disease.

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**Comment**

Second posting today of infected ticks being in places they supposedly shouldn’t be.  I think we need to truly accept the fact Lyme/MSIDS is everywhere.  Make sure you spread the word to medical practitioners, your family and friends – and frankly anyone who will listen.

https://madisonarealymesupportgroup.com/2018/06/07/where-ticks-are-and-what-they-carry-science-conversation-with-dr-cameron/  Infected ticks found in unlikely places including beaches.

Increasing Bbss in Tennessee Ticks

https://www.ncbi.nlm.nih.gov/m/pubmed/30044211/

Increasing Prevalence of Borrelia burgdorferi sensu stricto-Infected Blacklegged Ticks in Tennessee Valley, Tennessee, USA.

Hickling GJ, et al. Emerg Infect Dis. 2018.

Abstract

In 2017, we surveyed forests in the upper Tennessee Valley, Tennessee, USA. We found Ixodes scapularis ticks established in 23 of 26 counties, 4 of which had Borrelia burgdorferi sensu stricto-infected ticks. Public health officials should be vigilant for increasing Lyme disease incidence in this region.

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**Comment**

Another study showing infected ticks in places most don’t suspect and the importance of spreading the word.  I pray long gone are the days when a doc stares at a CDC map and announces it can’t be Lyme because it doesn’t exist in their state.

https://madisonarealymesupportgroup.com/2018/06/07/where-ticks-are-and-what-they-carry-science-conversation-with-dr-cameron/  Infected ticks are virtually everywhere. 

 

Co-Infection Patterns in Wisconsin Black Legged Ticks Show Associations Between Viral, Eukaryotic & Bacterial Microorganisms

https://www.ncbi.nlm.nih.gov/m/pubmed/30037148/

Co-Infection Patterns in Individual Ixodes scapularis Ticks Reveal Associations between Viral, Eukaryotic and Bacterial Microorganisms.

Cross ST, et al. Viruses. 2018.

Abstract

Ixodes scapularis ticks harbor a variety of microorganisms, including eukaryotes, bacteria and viruses. Some of these can be transmitted to and cause disease in humans and other vertebrates. Others are not pathogenic, but may impact the ability of the tick to harbor and transmit pathogens. A growing number of studies have examined the influence of bacteria on tick vector competence but the influence of the tick virome remains less clear, despite a surge in the discovery of tick-associated viruses.

In this study, we performed shotgun RNA sequencing on 112 individual adult I. scapularis collected in Wisconsin, USA. We characterized the abundance, prevalence and co-infection rates of viruses, bacteria and eukaryotic microorganisms.

We identified pairs of tick-infecting microorganisms whose observed co-infection rates were higher or lower than would be expected, or whose RNA levels were positively correlated in co-infected ticks. Many of these co-occurrence and correlation relationships involved two bunyaviruses, South Bay virus and blacklegged tick phlebovirus-1. These viruses were also the most prevalent microorganisms in the ticks we sampled, and had the highest average RNA levels.

Evidence of associations between microbes included a positive correlation between RNA levels of South Bay virus and Borrelia burgdorferi, the Lyme disease agent. These findings contribute to the rationale for experimental studies on the impact of viruses on tick biology and vector competence.

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**Eukaryotes are protozoans or parasites which includes worms (nematodes/helminths)**

Mainstream medicine has yet to take into account the synergistic effect of all of the pathogens found within a tick upon human suffering.  So far they continue to believe this is a one pathogen/one disease/one drug paradigm, hence the mono-therapy of doxycycline as their answer to this 21st century plague.

Until this changes, we are doomed.

NY Grants Approval of IGeneX’s Lyme ImmunoBlot Tests

https://www.businesswire.com/news/home/20180807005631/en/New-York-State-Grants-Approval-IGeneX’s-Newly

New York State Grants Approval of IGeneX’s Newly Developed Lyme ImmunoBlot Tests

Lyme ImmunoBlots (IgM and IgG) represents quantum leap in test performance over the traditional B. burgdorferi Western blots.

August 07, 2018 12:00 PM Eastern Daylight Time

PALO ALTO, Calif.–(BUSINESS WIRE)–The Division of Laboratories of the Department of Health of the State of New York has approved IGeneX’s newly developed Lyme ImmunoBlots (IgM and IgG), making it immediately available to New York practitioners.

Now, instead of sourcing test antigens from only one or two species of sonicated Borrelia, the ImmunoBlot is comprised of specific recombinant antigens from several species of Borrelia burgdorferi. The ImmunoBlot therefore detects the following US and European species of Lyme Borrelia: B. burgdorferi B31, B. burgdorferi 297, B. mayonii, B. spielmanii, B. californiensis, B. valaisiana, B. afzelii and B. garinii and makes the P31 epitope confirmation test unnecessary.

To test for all the above Borrelia burgdorferi species by Western blots, eight individual IgM and eight individual IgG tests are required. Performing 16 Western blots on each patient sample is expensive and impractical as opposed to just two tests with the Lyme ImmunoBlots.

“The Lyme ImmunoBlot is intentionally more inclusive for Borrelia burgdorferi sensu lato than the currently available Western blots because we now know that other species such as B. mayonii, B. californiensis and B. spielmanii all cause disease in the US,” said Dr. Jyotsna Shah, CEO of IGeneX. “With the increase of international travel in the last 10 years, people can get infected at home, other parts of the US or Europe depending on their lifestyle. Thus, it is important to have available a test that can detect the infection irrespective of where it was acquired.”

More Comprehensive Detection

The Lyme ImmunoBlot IgM detects the five following recombinant protein groups: P93, P41, P39, P31, and P23. Furthermore, the Lyme ImmunoBlot IgG detects these twelve recombinant protein groups: P93, P66, P58, P45, P41, P39, P34, P31, P30, P28, P23, and P18.

High Accuracy Across the Disease Spectrum

The accuracy of the Lyme ImmunoBlot has been established by exhaustive testing. The sensitivity with well-characterized samples has been shown to be greater than 93% whereas the two- tier testing recommended by CDC has a sensitivity of about 57.6% (Waddell LA et al. PLoS ONE. 2016;11(12):e0168613. doi:10.1371/journal.pone.0168613). Additionally, the ImmunoBlots detect the full spectrum of disease: early, active and late-stage disease. This high degree of sensitivity does not come at the cost of specificity. The specificity of the Lyme immunoblot is equivalent to CDC 2-tier testing (ELISA or IFA followed by Western blots).

New York State Department of Health Approval

The Clinical Laboratory Evaluation Program, Wadsworth Center, New York State Department of Health has approved the IGeneX Lyme ImmunoBlot (https://www.wadsworth.org/igenex-inc-reference-laboratory-12), making it available to all qualified New York practitioners and their patients. IGeneX works swiftly to ensure that this remarkable test can be utilized immediately.

The Wadsworth Center, a division of New York State Department of Health, is a science-based community committed to protecting and improving the health of New Yorkers through laboratory analysis, investigations, and research, as well as laboratory certification and educational programs. The Center serves a vital role in the New York State Department of Health’s efforts to protect and promote the health of New York’s citizens.

About IGeneX

For over 25 years, IGeneX has been at the forefront of research and development of diagnostic testing for Lyme disease, Relapsing Fever, and other tick-borne diseases. IGeneX arms its talented scientists with the most cutting-edge technology available to enable them in finding new solutions that challenge the status quo of testing for Lyme and associated tick-borne diseases. This team of experienced, hands-on experts develops these tests in-house using a wider spectrum of relevant proteins and strains that look for and detect more. The mission of IGeneX is to aid practitioners in their diagnosis of tick-borne illnesses by providing the most comprehensive testing possible. Learn more at: www. IGeneX.com

 

 

Lyme Nanotrap Test Granted Breakthrough Device Designation by FDA

Ceres Nanosciences’ Point-of-Care Nanotrap® Lyme Antigen Test System Granted Breakthrough Device Designation by U.S. Food and Drug Administration

Press Release: Ceres Nanosciences, Inc., Manassas, Virginia

July 12, 2018
http://www.ceresnano.com/press-release-breakthroughhttp://www.ceresnano.com/press-release-breakthrough

Ceres Nanosciences (Ceres) announced today that is has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for its new point-of-care Nanotrap® Lyme Antigen Test System.

Under the Breakthrough Device program, formerly the Expedited Access Pathways program, the FDA works with a test developer to reduce the time and cost from development to approval.

The Ceres’ Nanotrap® Lyme Antigen Test System is a powerful diagnostic test that is intended to be available in point-of-care settings, like a physician’s office or a walk-in clinic. Requiring only a patient’s urine sample, it will deliver results to the physician and patient at the earliest stages of infection, when treatment is most successful.

“We’re truly grateful to receive the FDA’s Breakthrough Device designation for the Nanotrap® Lyme Antigen Test System,” said Ross Dunlap, Chief Executive Officer of Ceres Nanosciences. “This will accelerate our delivery to patients of a much needed test for Lyme disease, a devastating and increasingly common infectious disease that can cause irreparable harm if not detected and treated early on.”

To achieve Breakthrough Device designation, a device must demonstrate compelling potential to provide more effective diagnosis for life-threatening or irreversibly debilitating diseases. In addition, the device must meet at least one of the following criteria: represent breakthrough technologies; no approved or cleared alternatives exist; offer clinically meaningful advantages over existing approved or cleared alternatives; or the availability of which is in the best interest of patients.

About Ceres Nanosciences, Inc.

Ceres Nanosciences is a privately held company, located in Prince William County, Virginia, focused on the development of research and diagnostic products using its unique and proprietary Nanotrap® particle technology. The Nanotrap® particle technology provides powerful biomarker capture and biofluid sample processing capabilities for a wide array of diagnostic applications and sample handling needs. The Nanotrap® particle technology was invented at George Mason University and developed under funding from the National Institutes of Health (NIH). With support from the NIH, the Defense Advanced Research Projects Agency (DARPA), the Bill and Melinda Gates Foundation, and the Commonwealth of Virginia, Ceres is focused on incorporating this technology into a range of innovative diagnostic products. Learn more at www.ceresnano.com http://www.ceresnano.com

Press Contact:

Ross M. Dunlap
Ceres Nanosciences, Inc
1.800.615.0418 ext. 202
rdunlap@ceresnano.com mailto:rdunlap@ceresnano.com

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**Comment*

Direct quote from Ceres:  http://www.ceresnano.com/nanotrap-lyme-test

The Nanotrap® Lyme Antigen (LA) Test is a novel, high sensitivity, DIRECT test for Lyme that will provide valuable information to assist a physician in diagnosing and treating Lyme disease at most stages of infection.

So this is not the end all.  People are going to slip through cracks here as well.  Please keep this in mind.

While using urine samples to directly detect Bb, (other tests use indirect testing by testing for antibodies), it relies on Bb being in the urine.  We all know Bb is a stealth organism that goes where it pleases – Often where it can’t be found.

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

https://madisonarealymesupportgroup.com/2017/08/15/emerging-lyme-tests/

Samuel Shor, MD, FACP: We’re involved in the study of 2 tests that are very promising. One is called the Nanotrap, which looks at a highly specific protein called OspA that is found across multiple strains of Borrelia. And what this technology does is super concentrate, in a urine sample, the presence of this protein and then further tests it, and, it’s 1000-fold more sensitive than the standard Western Blot. In our 2015 paper that was published in the Journal of Translational Medicine, in the preliminary erythema-migrans patients—who are very often negative in the ELISA test because they haven’t had the time to respond immunologically—24 out of 24 were positive with the Nanotrap test.

So it looks better but it’s not perfect…..