The objective of the proposed work is to determine whether a novel proprietory device designed to detect active Lyme disease spirochetal infection can be exploited commercially. This device is intended to perfuse the skin of a patient and automatically deliver the sample into a vessel containing culture medium. In Phase I of this project, various prototype models of the proposed perfusion device will be constructed and tested. The diagnostic sensitivity of the procedure will be evaluated in mice, rabbits and pigs. During Phase II, the device will be evaluated using human patients and its clinical utility explored at a site in which the transmission of Lyme disease is intense. This collaborative project links an academic laboratory that has been prominent in work on the biology of Lyme disease with a commercial laboratory experienced in the development and marketing of diagnostic products.
