Researchers at George Mason University (GMU) have received $1.2 million in federal funding from the U.S. Department of the Army to develop a urine-based test for the detection and diagnosis of Lyme disease.
"We have developed a urine test for Lyme disease that detects the bacteria (Borrelia species) that causes Lyme disease, making it a direct test to confirm an infection soon after the tick bite," Alessandra Luchini, principal investigator of the team comprising scientists from GMU's College of Science and College of Public Health in Fairfax, VA, said in a statement. "This leads to earlier treatment when necessary and could prevent the long-term debilitating effects of the disease.”
An antibody blood test is the current standard of care test for Lyme disease; this blood test measures the immune system response to the bacteria that cause Lyme disease. The GMU urine test detects molecules derived from the Borrelia bacteria themselves. In clinical trials conducted by GMU, the urine tests had a 90% sensitivity (true positive rate) and almost 100% specificity (true negative rate), the GMU researchers said.
In the three-year study, the GMU researchers will use banked samples from cross-sectional and longitudinal studies of acute Lyme patients from the Lyme Disease Biobank and banked specimens from Johns Hopkins University, respectively.
Additionally, the study will include a pilot collapsible urine collection cup shipped through the mail to a lab for analysis, with the aim of making collection and diagnosis easier and more accessible through telehealth.
