Leptospirosis Detection Dipstick

To address the U.S. Army need for a handheld, field-usable assay capable of diagnosing leptospiral disease in soldiers, resulting in early treatment with the appropriate antibiotic, Physical Optics Corporation (POC) proposes to develop a new Leptospirosis Detection Dipstick (LDD). The LDD is a handheld device based on a combination of lateral flow immunochromatography, lab-on-chip principles, and microarray technology. The LDD dipstick will rapidly (20 min) detect both pathogenic leptospira antigen and Immunoglobulin M (IgM) to the pathogens in a blood sample. The LDD will be a sensitive, portable, easy-to-use (one-step protocol), and inexpensive device with at least 85% of the sensitivity and specificity of current gold-standard assays. The device will use heat-stable reagents, have no special storage requirements, and require no power to operate. In Phase I, POC will demonstrate feasibility of the LDD by fabricating a prototype and demonstrating its capability to identify pathogenic leptospira antigen and specific IgM spiked into blood specimen and buffer, respectively; followed by delivery of a single lot of 100 prototype assays to the Contracting Officer Representative (COR) to be evaluated in a government laboratory. In Phase II, POC will provide up to 3 initial lots of 250 prototype assays each to the COR.