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It’s been forty-five years since the first Lyme disease case was identified in Old Lyme, Connecticut. Yet over the course of the past four and a half decades, there’s been little improvement in Lyme diagnostics. “The two-tier serological test, developed in the mid-1990s is still the recommended lab test used to support the clinical diagnosis of Lyme disease,” explains Paul M.  Arnaboldi, Ph.D., assistant professor of microbiology and immunology, “The sensitivity of these tests are so low in early disease that positivity is usually less than 50% at the time a patient first seeks medical care."

The arena of Lyme disease diagnostics is on the verge of changing: Dr. Arnaboldi has been relentlessly working to improve Lyme disease diagnostics since he arrived at NYMC nine years ago to join his mentor-turned-cohort, Raymond Dattwyler, M.D., professor of microbiology and immunology, and medicine. 

The current Lyme diagnostic is actually two tests (used together to minimize the risk of false-positives) that look at the immune response. The first test, which looks for antibodies that respond to Borrelia, is a very sensitive assay, but not very specific. The second test is used to validate the first test by confirming the presence of antibodies to a more diverse array of proteins using a test called a western blot. This second test is very specific but is insensitive, particularly for detecting early Lyme disease (when the immune response is first developing).

Dr. Arnaboldi is trying to develop a single-step test which should improve the ability to accurately and effectively diagnose Lyme disease—even in the early stages of the disease. “In our lab, we are achieving sensitivities as high as 70 percent while maintaining high specificity,” he explains. Dr. Arnaboldi is modifying antigens used in the first test so there will not be a need to use the lower sensitivity second test. This new approach is about mapping epitopes, the part of an antigen molecule to which an antibody attaches itself. “We're doing epitope mapping where we look for individual parts of the proteins that are unique to Borrelia and will only bind to the antibody activated in people who have had Lyme disease—ignoring other infections.  We express these parts of the protein as short peptides which can be combined from multiple targets to create a sensitive and specific assay” he says.

Last spring, a new assay from BioRad was approved by the FDA. “Some of the peptides that we have identified have been included in the new [BioRad] Total Lyme assay which is presently coming to market,” he says. Though the new test was not approved to be a single-step test, it is still a step in the right direction.

Now, Dr. Arnaboldi along with Dr. Dattwyler has set their sights on developing a point-of-care product that will deliver the new single-step test in which a doctor can run tests in the office. “We are collaborating with a lab out of UCLA to create a point-of-care Lyme test,” he says. “Working with Drs. Dino DiCarlo and Aydogan Ozcan at UCLA, we will put our antigens into their novel multiplex platform which can be used for rapid diagnosis directly in a physician's office. Instead of having to take blood and send it off to the lab, the physician will be able to perform a test in the office, and have results for the patient in less than 15 minutes,” he explains.