A direct, urine-based test to diagnose acute Lyme disease using actively secreted peptidoglycan as a biomarker.

Lyme disease is a growing and prominent human health problem caused by a group of spirochaetal bacteria that belong to the Borrelia genus. Persistent Lyme disease infection produces a multi-system disorder that may result in severe arthritis, carditis, neurological problems, and even death. Preventing severe disease requires immediate treatment, but current approaches to diagnose Lyme disease are indirect, serology-based assays that may fail early in infection. All Lyme disease-causing Borrelia species shed distinct and unique fragments of their peptidoglycan cell wall during growth. We exploited this fundamental biological process to develop an acute, urine-based diagnostic test. Using a cocktail of unique and highly specific monoclonal antibodies, our ELISA-mediated approach accurately reports on the status of an active, acute infection, in a laboratory animal model of Lyme disease, as well as humans. This rapid, simple, and innovative approach detects an active infection in as few as 3 days of transmission and in 88% of human patients yet to seroconvert-more than ∼2 weeks before serology would be positive.