Project Grant 2232930

SBIR PHASE I: HYBRID DNA-PROTEIN QUANTIFICATION PLATFORM FOR POINT-OF-CARE DIAGNOSIS OF SYPHILIS AND HUMAN IMMUNODEFICIENCY VIRUSES (HIV) -THE BROADER IMPACT/COMMERCIAL POTENTIAL OF THIS SMALL BUSINESS INNOVATION RESEARCH (SBIR) PHASE I PROJECT IS THE CREATION OF THE FIRST ALL-IN-ONE AUTOMATED SYPHILIS TEST AVAILABLE AT THE POINT-OF-CARE. THE NUMBER OF SYPHILIS CASES IN THE UNITED STATES HAVE DOUBLED IN THE PAST 5 YEARS WITH A FIVE-FOLD INCREASE IN CONGENITAL SYPHILIS PASSED FROM A PREGNANT MOTHER TO THE FETUS. ANNUAL INFECTIONS NOW ACCOUNT FOR $170 MILLION IN LIFETIME MEDICAL COSTS. THIS LOW-COST, PORTABLE TEST WILL ENABLE CARE PROVIDERS AND OUTREACH EFFORTS TO IMMEDIATELY DIAGNOSE AND TREAT PATIENTS IN A SINGLE VISIT TO HALT THE SPREAD OF SYPHILIS INFECTIONS IN THE MOST VULNERABLE POPULATIONS. SYPHILIS TESTING IN THIS PLATFORM WILL BE READILY COMBINED WITH HYBRID DETECTION OF HUMAN IMMUNODEFICIENCY VIRUSES (HIV) TO STREAMLINE SYPHILIS TESTING WITH EXISTING PROGRAMS FOR HIV DIAGNOSIS AND FURTHER ENCOURAGE UPTAKE OF THIS TEST SOLUTION INTO CLINICAL PRACTICE. THIS SMALL BUSINESS INNOVATION RESEARCH (SBIR) PHASE I PROJECT ADDRESSES THE NEED FOR EASIER SYPHILIS TESTING SOLUTIONS TO PROVIDE COMPREHENSIVE DIAGNOSIS ON-SITE WITH THE PATIENT. SYPHILIS DIAGNOSIS RELIES ON TWO SEPARATE ANTIBODY TESTS, OF WHICH ONE REQUIRES QUANTIFYING ANTIBODY LEVELS WITH A TEDIOUS LABORATORY PROCEDURE CALLED RAPID PLASMA REAGIN (RPR) TO CONFIRM IF THE PATIENT HAS AN ACTIVE INFECTION. THE LACK OF RESOURCES AND PERSONNEL TO CONDUCT RPR TESTING ON-SITE SEVERELY LIMITS THE ABILITY OF PUBLIC HEALTH CLINICS TO EFFECTIVELY DIAGNOSIS SYPHILIS IN A TIMELY MANNER. THIS PROJECT WILL COMBINE BOTH ANTIBODY TESTS INCLUDING QUANTITATIVE RPR INTO AN AUTOMATED CARTRIDGE FOR RAPID AND COMPLETE SYPHILIS DIAGNOSIS AT THE POINT-OF-CARE. THE RESEARCH PROPOSED IN THIS PROJECT WILL DEVELOP MAGNETIC PARTICLE-ENABLED ASSAYS FOR EACH ANTIBODY TEST AND INTEGRATE THE ASSAYS INTO A MULTIPLEXED PLASTIC CARTRIDGE. THESE CARTRIDGES, COMBINED WITH A PORTABLE INSTRUMENT, WILL ENABLE ALL STEPS REQUIRED FOR SYPHILIS DIAGNOSIS TO BE COMPLETED WITHIN MINUTES IN AN AFFORDABLE AND EASY-TO-USE FORMAT. THIS AWARD REFLECTS NSF'S STATUTORY MISSION AND HAS BEEN DEEMED WORTHY OF SUPPORT THROUGH EVALUATION USING THE FOUNDATION'S INTELLECTUAL MERIT AND BROADER IMPACTS REVIEW CRITERIA.