ABILITY OF QUALITY ASSURANCE TESTS TO DETECT PUNCTURED LATEX CONDOMS WITH POTENTIAL FOR VIRUS PENETRATION

How well do the quality assurance tests for latex condoms detect the p otential for virus penetration? Defective condoms were created by punc turing with small acupuncture needles (120, 160 or 300 mu m diameter) and were then tested by three quality assurance (QA) tests (the water leak test, a proposed electrical test, and the air burst test) and by a virus penetration test. Punctures (short tears) were detected by the FDA water leak test at the rate of 52% for punctures in the condom bo dy and 9% in the condom tip; by the proposed ISO electrical leakage te st (28% and 18% for body and tip, respectively); or by the 180 air bur st test (30% and 5%, respectively). A standardized in vitro test of vi rus penetration under physiologic-based conditions detected 100% and 4 8% of the punctures for body and tip, respectively. Thus the small tea rs created by puncture may not be detected in quality assurance tests, but would allow some virus penetration in the laboratory virus penetr ation test. A puncture in the tip of a condom was most likely to escap e detection by each of the test methods, presumably because a puncture in that location does not open up as easily as elsewhere. Data with t he air burst test indicated that raising the burst volume and/or burst pressure pass/fail limit would increase the likelihood of detecting a puncture defect to >93% when in the condom body, but to <15% when in the tip.