Pharmasan Labs, a partner company to NeuroScience Inc., has launched iSpot Lyme™, a novel diagnostic tool for detecting the bacterial infection caused by Borrelia Burgdorferi, the causative agent of Lyme disease. The iSpot Lyme test represents a breakthrough in diagnostic accuracy, leading to faster diagnosis and treatment.
The evaluation for diagnosis currently recommended by the Centers for Disease Control is a two-tier test consisting of Enzyme-Linked Immunosorbent Spot (ELISA) and Western Blot (WB) that detects antibodies to B. Burgdorferi. But its sensitivity is low—only about 30 percent in early stages and 50 percent in late. This gap in sensitivity leaves undiagnosed and untreated thousands of the approximately 32,500 new patients each year, as well as countless others who may have previously received false-negative results.
In response, Pharmasan Labs developed iSpot Lyme, a highly sensitive T cell-based Lyme ELISpot assay validated for the diagnosis of Lyme. By measuring T cell activity, iSpot Lyme accurately detects Lyme in 84 percent of cases and avoids false positives in 94 percent of cases, making it the most accurate and sensitive Lyme test available.
By detecting a cellular immune response that appears earlier in the disease than the antibody response detected by Western Blot, iSpot Lyme can detect Lyme only 2-3 weeks after exposure. Additionally, iSpot Lyme can detect antigen-specific T cell responses in seronegative patients, speeding treatment for patients who may have been previously misdiagnosed as negative for Lyme.
“Lyme disease is an increasingly common condition that can have devastating consequences,” said Chenggang Jin, Ph.D, MD, director of laboratory immunology at Pharmasan Labs. “With its higher specificity and sensitivity, along with its convenience and quick turnaround time, iSpot Lyme can be used for early Lyme detection, therapeutic monitoring and detection of recurring infections. The iSpot Lyme test is also helpful for retesting and ruling out Lyme in chronically ill patients.”