Rapid Immunodiagnosis of Drug-Resistant Bacterial Pathogens

PROJECT SUMMARY ABSTRACT
This proposal describes Phase II of the development of a rapid immunoassay test kit for
the determination oflactam antibiotic resistanceto be used as a point of care
diagnostic test for urinary tract infectionsTodayantibiotics for UTI are prescribed
empiricallywith no diagnostics available to clinicians to avoid treating resistant
infections with the very drug to which the pathogens are resistantThis problem has
resulted in ever increasing prevalence of resistancerendering many drugs unusableThe proposed test kit will be a lateral flow immunoassaysimilar in principle to a home
pregnancy testThe test design is based on monoclonal antibodies specific forlactamasesthe enzymes conferring resistance tolactam antibioticsIn Phase Ithe
applicant developed a working assay capable of distinguishinglactam resistant
bacteria fromlactam sensitive isolatesIn Phase IIthis assay will be converted into a
simpleminute test kitand a complete manufacturable product will be developedClinical validation studies will be carried out to determine the real world performance of
the productAt the successful conclusion of Phase IIwe expect to demonstrate a rapidsimpleand accurate test forlactam resistance in UTIenabling clinicians to test
unprocessed urine samples and determine the optimal antibiotics based on the resultsThis capability promises to revolutionize the management of bacterial UTIsgiving
clinicians the ability to selectively prescribe olderlactam antibiotics to test neagtive
patients with a high confidence of efficacySuch treatment is expected to improve
outcomes for patients while dramatically reducing the empiric use of broad spectrum
antibiotics