Implications of laboratory tests of condom integrity

Background: There is sufficient evidence from Food and Drug Administration laboratory experiments and clinical studies to draw conclusions about the r elative importance of holes and breakage to condoms. The laboratory test me thods determined penetration of viruses or virus-size microspheres through holes in condoms under conditions that simulated or exaggerated those expec ted in actual use, and determined the frequency with which condoms might pa ss virus or microspheres and the amounts of passage in each case. Goals: To summarize and comment on the significance of test results on late x, polyurethane, and natural membrane condoms as barriers to virus passage. Study Design: Published and unpublished data addressing three distinct conc erns were analyzed: (1) passage of virus or microspheres through small hole s or pores inherent in the material of "intact" condoms which are undetecta ble by the standard water leak quality assurance test, (2) passage of virus or microspheres through larger holes in "leaker" condoms detectable by the water leak test but marketed because of the finite acceptable quality leve l (AQL) of the test, and (3) passage of virus through condoms that break du ring use. Results: Extrapolating to the passage of semen expected during actual use a llowed an analysis of the relative importance of breakage and water-leak-de tectable or water-leak-undetectable holes. Conclusions: The relative importance of breaks and holes is related to the volume of semen that contains an "infectious dose" of a sexually transmitte d disease (STD). When 0.1 mL to 1.0 mL exposures to semen are necessary for disease transmission, the risk during latex condom use primarily results n ot from holes, but from breakage of condoms. For smaller volumes of semen e xposure (0.00001 mt and less), the presence of holes can be as important as breaks. The same qualitative argument pertains to a comparison of "leaker" condoms to the large majority of "intact" condoms.