New tests may help early detection of Lyme disease

Thu, 01/03/2019 - 8:45pm

There’s some good news in the battle against Lyme disease.

A group of researchers and scientists have determined that new technologies could make diagnoses sooner than current tests allow. The new testing methods would also be more precise and less susceptible to so-called false-positives.

The tests would use blood samples to detect DNA or proteins of the bacteria responsible for causing Lyme disease, allowing for earlier treatment.

Lyme is a debilitating disease that can cause arrhythmias, migraines, rash, and joint, neurological and cardiac disorders. 

Clinicians have grown frustrated with waiting for a supportive test for treating Lyme disease, which is challenging to diagnose when using the traditional two-tiered antibody testing known as ELISA (enzyme-linked immunosorbent assay), followed by a Western immunoblot test. According to the Center for Disease Control and Prevention’s website, “The immunoblot is a laboratory test that looks for antibodies the body makes against different molecules, or antigens, that are part of the Borrelia burgdorferi bacteria.”

With traditional methods, in some cases, by the time signs of an infection, or antibodies, are detected in a person’s bloodstream time is lost for optimal treatment with antibiotics. In some cases, antibody testing is initially negative, causing treatment to be delayed, and complications can occur, such as arthritis, meningitis, or heart arrhythmias.

Dissatisfied with current testing methods, researchers and scientists from Rutgers University, Harvard University, Yale University, the National Institute of Allergy and Infectious Diseases, FDA, the CDC, and other institutions, met in September of 2016 at Cold Spring Harbor Laboratory Banbury Center in Huntington, New York with the collective goal of assessing new laboratory technology for the diagnosis of Lyme disease.

What they learned was addressed in two papers published in the journal Clinical Infectious Diseases, which noted that, “New technical advances and knowledge demonstrate that direct tests for early active infection are ready for practical assessment in Lyme disease.”

Dr. Steven Schutzer, lead author and a physician-scientist at Rutgers Medical School, said one new method would involve the use of a PCR (polymerase chain reaction) or genome sequencing blood test, which researchers determined would be highly effective in detecting Lyme disease. The researchers emphasized its potential after assessing technologies that have FDA approval to detect other bacterial and viral infections, such as HIV, influenza, streptococcus, and others, within a 24-hour period.

During a phone interview, Schutzer said, “Our goal was to assess the state -of-the-art technology that could be used for Lyme testing. Now the new hope is to have tests that work much earlier than antibody tests to detect the disease. It wouldn’t surprise me that within the next year there is a direct test that is available to treat Lyme disease.”

Schutzer said current antibody tests can take up to three or more weeks for antibody levels to increase to a detectable level. The PCR test would be more immediate and precise, while aiding clinicians with prescribing antibiotics to help prevent severe long-term health problems.

Schutzer said the best method would be to use the DNA test to quickly reveal an active infection, and an indirect test to determine the presence of antibodies that are present a few weeks after infection occurs. “This is because the time of the infection may not be known.”

Dr. Peter Krause of the Yale School of Public Health and Yale School of Medicine said the new direct testing methodology would bypass the hurdles associated with old testing methods, leading to earlier detection of bacterial DNA and thus earlier treatment.

“It’s basically a rapid DNA blood test,” said Krause, who has visited Block Island the past 25 years conducting research and testing for Lyme disease at the Medical Center. Krause and his Yale team recently worked with Dr. Maria Diuk-Wasser, and her Columbia University team, on a collaborative research study of Lyme disease and babesiosis ecology and epidemiology on Block Island.

Krause said, “The new DNA technology is likely to be an advancement over the old blood testing method, which could not detect active Lyme disease or presumptive infection when the antibodies to the Lyme agent were too low to detect early in the course of the disease. The antibody test is more likely to be positive a few weeks after an infection, after a person’s body has time to develop antibodies.” The results from a PCR test are usually available within 24 hours after a sample is received.

New Lyme vaccine

In related news, The Block Island Times reported in June that the drug company Valneva is undergoing trials for its Lyme vaccine called VLA15. The vaccine stimulates the human immune system to produce antibodies that attack bacteria inside of the tick.

Valneva sent the following statement to The Times regarding the status of its trials with VLA15: 

“We are working to develop VLA15 as a safe and effective preventative vaccine against Lyme disease. VLA15 targets outer surface protein A (OspA) of Borrelia, one of the most highly-expressed surface proteins on the bacteria when present in a tick. We reported positive interim phase one results for VLA15 in 2018 and previous pre-clinical data showed that the vaccine has the potential to provide protection against the majority of the Borrelia species pathogenic for humans. We are planning to commence a phase two by end of year and we look forward to continuing our work to bring this vaccine forward to the people who need it the most.”