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New Study Shows Nearly One-Third of Lyme Disease Test Results are Inaccurate for Patients with Lyme Disease Rash

PORTOLA VALLEY, Calif., Feb. 26, 2020 /PRNewswire/ -- Bay Area Lyme Foundation, a leading sponsor of Lyme disease research in the U.S., announces results published in the Journal of Clinical Microbiology, a journal of the American Society for Microbiology, that point to limitations of currently available diagnostic tests for early-stage Lyme disease, and highlight the need for more research toward improved diagnostics and treatments. Among the findings, the Centers for Disease Control's standard two-tier testing algorithm (STTTA) for Lyme disease failed to accurately diagnose 71% of blood samples from individuals presenting with a Lyme rash, also known as an erythema migrans, greater than 5 cm in endemic areas. These samples are part of the Lyme Disease Biobank (LDB), which was founded to catalyze new research in the understanding, diagnosis and treatment of Lyme disease and other tick-borne infections. Samples are available for research use through an application process to scientists who already work in tick-borne infections as well as those new to the field.

"For an epidemic like Lyme disease that is growing at such an alarming rate, there needs to be more research, greater understanding, better diagnostics, and improved treatments," said Charles Chiu, MD, PhD, Professor of Laboratory Medicine and Medicine, Division of Infectious Diseases, University of California, San Francisco, and Bay Area Lyme Foundation scientific advisory board member, who is currently using samples from the Lyme Disease Biobank for his research. "This study draws attention to the fact that we simply don't have an accurate test for Lyme disease at present, and this is exactly why clinicians still need to rely on their knowledge of the signs and symptoms of early Lyme disease to diagnose patients and provide prompt treatment."

These findings also reinforce that Lyme disease does occur in individuals who do not have a erythema migrans, and those with rashes smaller than 5 cm. Samples that were laboratory confirmed for Lyme disease (N=82) were more likely to be enrolled with a Lyme rash (83%) and more likely to present with a Lyme rash greater than 5 cm (74%). However, 26% of laboratory confirmed Lyme disease did not present with a Lyme rash greater than 5 cm, including 9% enrolled as having a Lyme rash smaller than 5 cm and 17% enrolled without any skin manifestations.

"Patients who do not exhibit a rash likely face the greatest challenges in being diagnosed – not only because many healthcare providers specifically look for this sign to diagnose patients, but because the lack of a rash correlated to less likelihood of an accurate serology test, according to this study," added Dr. Chiu.

Currently comprised of samples from more than 800 participants, the Lyme Disease Biobank utilized 550 patient and control samples (298 cases and 252 controls) collected from 2014 through 2018 for this study. Each sample was tested using both a first tier ELISA and second tier immunoblot (i.e., western blot), and the STTTA was applied. Assays were also performed to detect the presence of tick-borne pathogens (polymerase chain reaction (PCR)), and a subset of samples was evaluated by culture. Of the 298 cases enrolled with signs and symptoms of Lyme disease, only 28% were identified as positive for Lyme disease through these methods, or a modified two-tier testing algorithm, consisting of two positive ELISAs in patients with Lyme rash (erythema migrans) greater than 5 cm. This collection highlights and reinforces the known limitations of STTTA testing in early Lyme disease.

"This study highlights the limitations of available tools for all healthcare providers whose patients may be infected with Borrelia burgdorferi, the bacteria that causes Lyme disease. Our hope is that healthcare providers will consider these findings when evaluating patients with signs and symptoms of early Lyme disease," said Liz Horn, PhD MBI, the study's lead author and principal investigator for Lyme Disease Biobank. "Our original goal was to characterize the samples we were making available to investigators working on new diagnostics for Lyme disease. We didn't expect to find such large inaccuracies in current laboratory tests that support clinical decision-making."

According to findings, participants presenting with a Lyme rash greater than 5 cm were more likely to be positive by any serologic test. For samples taken while patients were experiencing signs and symptoms of early Lyme disease, a positive ELISA was found in 38-43% of patients with Lyme rashes larger than 5 cm, 17-35% of patients with rashes smaller than 5 cm, and 15-27% of patients without a rash, while 5-11% of controls also received a positive ELISA (ranges represent percent positive using different first-tier tests). For the second tier immunoblots, more cases were positive for IgM than IgG (as would be expected for early Lyme disease).

"We are thrilled to see the Lyme Disease Biobank helping to uncover the critical challenges facing patients and physicians as well as the urgent need for more accurate Lyme disease diagnostics," said Alex Cohen, President and Co-founder of the Steven & Alexandra Cohen Foundation, whose funding has been instrumental in the rapid expansion of the Lyme Disease Biobank over the past four years.

Currently, there are 50 research projects that rely on Lyme Disease Biobank samples.

About Lyme Disease Biobank
The Lyme Disease Biobank (LDB), a program of the Bay Area Lyme Foundation, is a non-profit organization working to accelerate research of Lyme disease and other tick-borne infections. With a collection of biological samples from more than 800 participants, including serum, blood, urine and tissue, LDB provides much-needed samples to researchers working to better understand tick-borne diseases and develop improved tests and therapeutics. Blood and urine samples are collected from the Northeast and Upper Midwest areas of the U.S., as well as the San Francisco area and, now, San Diego, and tissue samples are collected throughout the U.S.

Healthcare providers, and patients interested in donating blood, urine or tissue samples can learn more here.

Researchers interested in obtaining samples should visit www.lymebiobank.org or contact info@lymebiobank.org.

About Lyme Disease
The most common vector-borne infectious disease in the country, Lyme disease is a potentially disabling infection caused by bacteria transmitted through the bite of an infected tick to people and pets. If caught early, most cases of Lyme disease can be effectively treated, but it is commonly misdiagnosed due to lack of awareness and unreliable diagnostic tests. There are more than 400,000 new cases of Lyme disease each year, according to statistics released in 2018 by the CDC. As a result of the difficulty in diagnosing and treating Lyme disease, more than one million Americans may be suffering from the impact of its debilitating long-term symptoms and complications, according to Bay Area Lyme Foundation estimates.

About the Cohen Lyme & Tickborne Disease Initiative 
The non-profit organization, the Steven & Alexandra Cohen Foundation, is leading the fight against Lyme and tickborne diseases by educating health professionals, sharing new knowledge, advancing research, accelerating market solutions, and advocating the highest quality care for patients. It advances academic science, creates educational tools and platforms, communicates the latest information and study findings, supports policies that promote the highest quality patient care, strengthens the pipeline of tickborne disease specialists and other health professionals, and focuses on addressing health disparities. The Foundation also collaborates with the U.S. government as well as patient, health, and science professionals and other organizations to further mutually shared goals, including greater awareness of Lyme and tickborne diseases. To learn more, please visit steveandalex.org.

About Bay Area Lyme Foundation
Bay Area Lyme Foundation, a national organization committed to making Lyme disease easy to diagnose and simple to cure, is a leading public not-for-profit sponsor of innovative Lyme disease research in the U.S. A 501c3 non-profit organization based in Silicon Valley, Bay Area Lyme Foundation collaborates with world-class scientists and institutions to accelerate medical breakthroughs for Lyme disease. It is also dedicated to providing reliable, fact-based information so that prevention and the importance of early treatment are common knowledge. A pivotal donation from The LaureL STEM Fund covers overhead costs and allows for 100% of all donor contributions to Bay Area Lyme Foundation to go directly to research and prevention programs. For more information about Lyme disease or to get involved, visit www.bayarealyme.org or call us at 650-530-2439.

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SOURCE Bay Area Lyme Foundation