New Test Could Help Monitor Lyme Disease Treatment

The new, recently patented method is designed not only to diagnose Lyme disease but also to monitor treatment progress and indicate when Lyme disease-causing bacteria are cleared from the body.

Lyme disease is a tick-borne illness caused by the bacterium Borrelia burgdorferi and, rarely, Borrelia mayonii. It is transmitted via the bite of a black-legged or "deer" tick. It causes fever, fatigue, headache, or flu-like symptoms, and sometimes, a round "bullseye" rash appears on the skin. Healthcare providers typically treat Lyme disease with doxycycline, an antibiotic.

If left untreated, or if treatment fails to rid the body of Borrelia, the disease can progress and affect the heart, joints, and nervous system. Estimates suggest that antibiotic treatment fails to eliminate the disease in at least 10% to 20% of those infected.

The primary issue with Lyme disease is that it can be challenging to diagnose and treat. Since it's a tick-borne illness, some people may not realize they've had a tick bite and ignore the symptoms, believing it's another health condition.

Moreover, testing for Lyme has its own set of issues, as the accuracy of antibody tests depends on how long the person has been infected.

Currently, healthcare providers use the enzyme-linked immunosorbent assay (ELISA) test and the Western Blot test to confirm a Lyme disease diagnosis. In many cases, the ELISA test remains positive after treatment, making it difficult to know whether the person is free of Borrelia.

These and other obstacles associated with current testing methods leave gaps in Lyme diagnosis and patient care.

Now, a new patented method for diagnosing and monitoring Lyme disease — one that differs from current tests — could be on the horizon. If proven accurate in clinical trials and approved by the U.S. Food and Drug Administration (FDA), the new test has the potential to be a game changer for healthcare providers and their patients.

What is the new Lyme test?

The Lyme test patent, published on August 20 and shared by QIAGEN Sciences LLC, Biopeptides Corp., and Gundersen Lutheran Medical Foundation, Inc., describes a first-of-its-kind method for diagnosing Lyme disease and predicting Lyme disease-causing bacterial elimination after treatment.

According to the patent documents, the test uses blood samples and specific laboratory techniques to diagnose and monitor people with Lyme disease.

To diagnose the condition, the new method exposes a blood sample to small synthetic protein fragments called peptides that mimic various parts of the Borrelia bacteria, which the immune system can recognize.

If specific immune system cells, called T-cells in the blood sample react to these peptides by producing interferon-gamma (IFN-γ) — a cytokine that plays a critical role in various immune responses — it can indicate the individual has Lyme disease.

The new method can potentially help healthcare providers monitor treatment success after the person has undergone antibiotic treatment, which is critical since Borellia can be extremely challenging to eliminate.

To track progress, another blood sample would be taken and the test procedure repeated. If the person's immune system cells react and produce IFN-γ, it means some Lyme disease-causing bacteria are still present in the body.

In contrast, if no immune response occurs, the treatment worked, and Lyme bacteria are no longer present.

How does this Lyme test compare to currently available tests?

The ELISA and Western Blot are indirect tests since they measure the body's response to the infection, not detect the infection itself. It can take weeks for the immune system to produce antibodies at a level that tests can detect.

Casey Kelley, M.D., ABoIM, founder and medical director of Case Integrative Health tells Healthnews that the Western Blot test has flaws.

"If you have a patient with immunosuppression (ie: they are not able to make antibodies), the test will look falsely negative," Kelley explains. "The test is also difficult to use for determining if the infection is active or not, as the IgG antibodies can remain positive for years, and it can't differentiate between a chronic infection, active infection, or a post-infection with immunity."

Kelley adds that it can take 4-6 weeks for a Western Blot test to show a positive result after an acute infection, which can delay patient treatment.

Arick P. Sabin, D.O., an infectious disease specialist at Gundersen Health, part of Gundersen Medical Foundation, tells Healthnews that current Lyme Disease tests cannot easily distinguish active from past infections.

"Nor are they easy enough to interpret to give patients or providers a straight answer sometimes as to whether a patient really, truly does have Lyme disease right now or has previously been exposed," Sabin adds.

The proposed new testing and disease tracking method differs from the ELISA and Western Blot tests as it does not assess antibody response. Instead, it directly tests immune system cell response — measured by the presence or absence of IFN-γ — to specific antigens from the Lyme disease causing bacteria.

If proven accurate in clinical trials involving participants at varying stages of Lyme disease and control groups, the test would allow healthcare providers to determine the stage of the infection and whether treatment was effective.

Still, the FDA would have to approve the test before clinicians could use it to test and monitor patients.

The potential benefits of a Lyme diagnostic and monitoring test

Linas Černiauskas, Ph.D. candidate and health content researcher with Healthnews, says that to this day, no test is available that would allow clinicians to monitor the progression and elimination of Lyme disease, and this test would remove that limitation.

"Meaning that it would allow medical specialists to avoid undertreatment or overtreatment of Lyme disease with antibiotics," Černiauskas explains. "Undertreatment may result in persisting infection and potentially cause individuals long-lasting debilitating effects of Lyme disease, while overtreatment may cause antibiotic resistance which may render current treatment strategies for various bacterial infections ineffective in the future."

Kelley notes that having an accurate, reliable test that can help define acute, chronic, and post-disease status would be a significant step toward treating Lyme Disease.

"I cannot state loud enough that this alone would benefit patients immensely. Knowing what the infection is, whether it's still active, and when you are done treating it would streamline treatment and allow patients to heal faster," Kelley says.

While the patented method is promising, Sabin says it's unclear if or when the new test would be available to healthcare providers.

"We just completed a large clinical trial (as a site participant) using this new technology. Results are pending," Sabin tells Healthnews.

Depending on the trial results, Sabin adds that the new method would still need to go through the regulatory system and gain FDA approval, which can be a long and costly process.