This proposal describes Phase I of the development of a rapid point-of-care test kit for the direct measurement of bacteriuria as a diagnostic for urinary tract infections (UTIs). While bacteriuria at a level of 105 CFU/ml is the gold standard for UTI diagnosis, in practice the required urine culture is unfeasible due to the typical 2-day delay in obtaining results. UTI diagnosis is aided by other in-office urinalysis dipsticks, but studies have shown that there is a high rate of misdiagnosis and consequent overtreatment with antibiotics. The proposed test kit will allow, for the first time, a direct """"""""dipstick"""""""" measurement of bacterial concentration in urine within 10 minutes, in time to aid diagnosis of UTI during the initial office visit. The proposed test kit will be a lateral flow immunoassay, similar to a home pregnancy test. In the test design, anti-bacteria monoclonal antibodies (MAbs) will be used to directly bind to bacterial cells in a urine sample, producing a visual result calibrated to 105 CFU/ml. The test format will be based on the applicant Company's proprietary Watersafe(r) Bacteria Test, a rapid immunoassay for bacteria in swimming pools, which is currently manufactured and marketed by the Company. This test is, to our knowledge, the only rapid immunoassay for bacteria that does not require culture or sample concentration. Additionally, the Company has already developed >60 monoclonal antibodies for broad-spectrum bacterial detection, and these will also be used in the proposed test kit. In Phase I, the applicant will develop a prototype test kit and determine its sensitivity for several uropathogenic strains of E. coli and other species at the level of 105 CFU/ml. In Phase II, the test kit will be further optimized for sensitivity and specificity using spiked and clinical samples, and validation studies will be carried out to determine the real-world performance of the product. At the successful conclusion of Phase II, the test kit will be ready for manufacturing, FDA review, and marketing. The estimated cost of the test to the end user will be $2.00 - $5.00 per test, far less than the cost of urine culture and in line with the cost of current urine dipsticks.test kit matching the performance specifications dictated by current urine culture guidelines - the gold standard diagnostic for UTI.
Urinary tract infections are some of the most common cause of physicians'office visits, accounting for over 8,000,000 visits per year in the US. The gold-standard diagnostic method for UTI, urine culture to detect bacteria, is not currently feasible as a routine procedure due to the 2-day delay in obtaining results. This proposal aims to develop a simple, inexpensive, 10- minute """"""""dipstick"""""""" test for bacteria in urine, to give physicians the ability to accurately diagnose UTI during the initial office visit by the patient.
