PREDICTION OF VIRAL LEAKAGE THROUGH CONDOMS

THE RESEARCH OUTLINES A PROPRIETARY, POTENTIALLY PATENTABLE FEE-FOR-SERVICE METHOD TO PREDICT VIRAL LEAKAGE, SUCH AS HIV, THROUGH CONDOMS - IN MANUFACTURERS' PRODUCTION LOTS DURING OR IMMEDIATELY POST PRODUCTION. THE STUDY WOULD STATISTICALLY EXPAND RESULTS INDICATING THAT AMONG 31 BRANDS, SOME CONDOMS FROM BRANDS WITH THE LOWEST ASTM/ISO SCORES LEAKED HIV, WHILE HIGH SCORERS DID NOT. 100 CONDOMS FROM EACH OF FOUR LOWEST SCORERS WILL BE CHALLENGED WITH HIGH TITRE BACTERIOPHAGE PHIX-174 (DIAM. <HCV/HBV). LEAKAGE WILL BE QUANTITATIVELY ASSAYED WITH A DETECTION LIMIT OF A SINGLE PHIX-174 PARTICLE LEAKED THROUGH THE CONDOM. TEST CONDOMS WILL BE PRE-STRESSED ON A COITAL SIMULATION INSTRUMENT TO SUBJECT THEM TO REPRODUCIBLE CONDITIONS AKIN TO THOSE DURING SEXUAL INTERCOURSE. IF LEAKAGE IS ADEQUATELY CONFIRMED, FUTUREWORK WILL MORE FULLY ASSESS LEAKAGE IN HIGH AND INTERMEDIATE SCORERS, CORRELATING ALL RESULTS WITH INDIVIDUAL ASTM/ISO TESTS VALUES. THE GOAL IS A RAPID METHOD OF PREDICTING PRODUCTION LOTS' LEAKAGE POTENTIAL, THROUGH AN ASTM/ISO INDEX OF CRITICAL SCORE VALUES. LIKE THE FDA'S WATER LEAK MONITORING, THE METHOD WOULD TEST PRODUCTION LOTS, NOT INDIVIDIAL CONDOMS.