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A sensitive method for evaluating condoms as virus barriers
C D Lytle1, J E Duff, B Fleharty
1U.S. Food and Drug Administration, Office of Science and Technology, Center for Devices and Radiological Health, Rockville, MD 20857, USA.
Abstract:
A standard test is needed to evaluate condoms as barriers against sexually transmitted diseases, particularly those caused by viruses. The proposed method presented here consists of a previously published simple method using physiologic-based conditions plus improvements to increase test sensitivity and decrease confounding factors such as contamination. Limitations of the method were determined by measuring virus penetration through small, well-defined holes. The method can detect penetration of 2 nL (2 x 10(-6) mL) of challenge virus suspension as well as a hole of 2 microns diameter in a latex condom. The data also indicated that virus penetration of latex condoms occurred quickly, and the hole was then apparently closed or blocked.