Lateral Flow Immunoassay for Rapid Detection of Borrelia burgdorferi from Ticks

Lyme disease is a vector-borne illness caused by infection with B. burgdorferi. Hard ticks (Ixodes spp.) acquire the spirochete from a natural reservoir of small mammals; transmission to humans occurs via the bite of an infected tick. By any measure, Lyme disease is one of the most serious emerging infectious diseases that threaten public health in the United States. New estimates from the CDC indicate that as many as 300,000 people are infected each year. Endemic areas of Lyme disease occur along the northeastern and Midwest regions of the United States. These areas, however, continue to spread and in 2013 forty-five of the fifty states reported at least one case. The goal of this SBIR proposal is to develop a field-deployable assay to rapidly detect B. burgdorferi in ticks. This technology will greatly increase the readiness of Service personnel and the general public against the threat of Lyme disease. Detection will be accomplished by constructing a lateral flow immunoassay (LFI) that targets the outer membrane lipoprotein OspA, which is abundantly expressed by B. burgdorferi within the tick midgut. The LFI is an ideal assay for resource-limited settings; key features include portability, high sensitivity/specificity, and rapid result (<30 min. inclusive of sample preparation).