Portable Rapid Test for Diagnosis of Campylobacter Enteritis and Shigella Dysentery in Operational Ship and/or Field Environments

Campylobacter spp. and Shigella spp. are two of the major causes of gastro-intestinal disease worldwide and thus pose a significant medical threat to military personnel posted overseas. Both pathogens produce a severe colonic infection with similar clinical symptoms. This similar symptomology makes an accurate diagnosis of Campylobacter enteriris or Shigella dysentery problematic and poses a major medical problem in that therapeutic measures to treat these infections differ substantially and are often contraindicated. Development of simple, rapid and highly sensitive diagnostic assay(s) to identify and distinguish these pathogens would prove immensely beneficial to both the civilian and military communities. This Phase I effort will evaluate the ability of polyvalent antisera generated against inactivated, virulence-enhanced Campylobacter spp. or Shigella spp. whole cell vaccines, produced using MicroCarb proprietary methodologies, to detect a broad range of clinically relevant serotypes and/or species within these specified pathogen groups. Phase II will involve incorporation of these reagents into a military compatible assay format and evaluating the systems performance (i.e. sensitivity and specificity) with clinical specimens