ISSN: 0090-3973
Page Count: 8

Two Parameters Limiting the Sensitivity of Laboratory Tests of Condoms as Viral Barriers
Lytle, CD
Center for Devices and Radiological Health, Food and Drug Administration and Biocon, Inc., MD

Routson, LB
Center for Devices and Radiological Health, Food and Drug Administration and Biocon, Inc., MD

Thomas, DP
Center for Devices and Radiological Health, Food and Drug Administration and Biocon, Inc., MD

Regnault, WF
Center for Devices and Radiological Health, Food and Drug Administration and Biocon, Inc., MD

Cyr, WH
Center for Devices and Radiological Health, Food and Drug Administration and Biocon, Inc., MD

(Received 11 December 1995; accepted 9 April 1996)

Abstract

The practical limits of a laboratory test for evaluating condoms as virus barriers were characterized by determining virus penetration through small punctures in latex condoms. The test quantifies virus penetration through a pressurized, restrained condom filled with challenge virus. Estimation of the minimum-detectable hole (narrow slit) dimensions indicated that a limiting factor in virus transmission through such a puncture is fluid flow. The virus penetration rates decreased with time, apparently caused by the hole closing or being blocked, indicating that extending the test duration to allow more virus penetration was of limited value. Further, it was found that adsorption of virus particles during passage through a hole may limit the useful sensitivity of the test. With bacteriophage ϕX174 as the challenge virus, the practical limit for detecting virus penetration may be approximately 2 × 10⁻⁶ mL; with more adsorptive viruses, the test would be less sensitive.

Keywords:
condom test, punctured condom, latex condom, viruses, virus barrier, protective clothing

Paper ID: JTE11305J
DOI: 10.1520/JTE11305J
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