Our proprietary reagent combines a color changing reagent that responds to bacterial metabolic activity, and to certain specific enzymes produced by some bacteria. The amplification scheme enables a signal whose magnitude scales with pathogen concentration, with a lower limit of 100 CFU/mL (when adding 50 micro-liters of the test sample, with about 5 CFU in each test sample), as shown below. We use this output to develop a quantitative diagnosis on pathogen concentration that is good to within a factor of 5.
We characterize the metabolic activity of the causative pathogen, and then repeat those measurements with varying amounts of antimicrobial. The result is a rapid characterization of the MIC (Minimum Inhibitory Concentration MIC). We have found that the value of this MIC developed by the rapid test corresponds to the MIC developed by the standard, culture based method (as defined in the CLSI M100 standards document) to within a factor of 2, which is the acceptable dilution criterion on the CLSI standard.
For urine samples, the testing can be initiated directly on the test sample without any incubation. Normally, these measurements require several hours and a starting bacteria concentration of about 1000,000 CFU/mL. Our proprietary reagent enables this measurements in 20 minutes from as little as 100 CFU/mL.
We subclassify the pathogen based on the production of certain enzymes (which our reagent recognizes), and on the response of that causative pathogen to different media.
We are now providing this test as a service for local animal hospitals. We anticipate being able to sell this test for use in animal hospitals by Q2/2020, and FDA approvals for use in humans by 2021