Test Method for Evaluating the Permeability of Intact Prophylactics to Viral-Size Microspheres Under Simulated Physiologic Conditions

Sm, Retta; Wa, Herman; Je, Rinaldi; Carey, R. F.; Ba, Herman; Tw, Athey

doi:10.1097/00007435-199118020-00011

Cited by 18 publications

(5 citation statements)

References 9 publications

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“…The anionic FC-129 and the cationic FC-135 are Fluorad fluorochemical surfactants (3M, St. Paul, Minn.), which were generously provided by S. M. Retta, Center for Devices and Radiological Health, Food and Drug Administration. Triton X-100 has been used as a surfactant in a test of condoms as virus barriers (10), as have Tween 80 in the American Society for Testing and Materials test of surgical gown material as virus barriers (2) and FC-129 in the test of condoms as barriers to microspheres of the size of human immunodeficiency virus (13).…”

Section: Methodsmentioning

confidence: 99%

“…The goals of this study were (i) to identify which potential surrogate virus adsorbs least in saline to binding membranes and (ii) to identify conditions that minimize virus adsorption, including additions of surfactants, serum, or culture broth. The choice of additives was governed by the use of surfactants or culture broth in established tests of barrier materials (2,10,13) and the likely presence of serum or some other body fluid during real-life use of a barrier material (e.g., serum during use of a medical glove or serum and semen during use of a condom). Virus adsorption was determined using binding membranes as filters in a filtration protocol previously used with sizing filters (11).…”

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confidence: 99%

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Minimized virus binding for tests of barrier materials

Lytle

Routson

1995

Appl Environ Microbiol

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Viruses are used to test the barrier properties of materials. Binding of virus particles during passage through holes in the material may yield misleading test results. The choices of challenge virus and suspending medium may be important for minimizing confounding effects that might arise from such binding. In this study, different surrogate viruses, as well as different support media, were evaluated to determine optimal test parameters. Two membranes with high-binding properties (nitrocellulose and cationic polysulfone) were used as filters to compare binding activities of different surrogate challenge viruses (MS2, X174, T7, PRD1, and 6) in different media. The media consisted of buffered saline with surfactants, serum, or culture broth as additives. In addition, elution rates of viruses that bound to the membranes were determined. The results suggest that viruses can bind by hydrophobic and electrostatic interactions, with X174 displaying the lowest level of binding by either process. The nonionic detergents Triton X-100 and Tween 80 (0.1%) equally minimized hydrophobic interactions. Neither anionic nor cationic surfactants were as effective at nontoxic levels. Serum was effective at reducing both hydrophobic and electrostatic binding, with 2% being sufficient for eliminating binding under our test conditions. Thus, X174 remains the best choice as a surrogate virus to test barrier materials, and Triton X-100 (0.1%) remains a good choice for reducing hydrophobic binding. In addition, binding of viruses by barrier materials is unlikely to prevent passage of blood-borne pathogens.

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Section: Methodsmentioning

confidence: 99%

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confidence: 99%

Minimized virus binding for tests of barrier materials

Lytle

Routson

1995

Appl Environ Microbiol

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“…One possible confounding factor in such laboratory tests is virus adsorption leading to removal of virus, particularly during passage through the barrier (8,10). The nonionic surfactants Triton X-100 and Tween 80 are used in such tests to control the surface tension of the challenge fluid (2,9,12) and are also known to prevent virus adsorption in some situations (3,4,15,17), including to the highly binding membranes Bio-Trace NT (nitrocellulose) and BioTrace HP (cationic polysulfone) (8). It is of interest to know whether the same concentrations of surfactants, in addition to preventing adsorption, can elute adsorbed viruses.…”

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confidence: 99%

Elution of viruses by ionic and nonionic surfactants

Fujito

Lytle

1996

Appl Environ Microbiol

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The ionic and nonionic surfactants sodium dodecyl sulfate and Triton X-100, respectively, eluted two viruses, X174 and PRD1, which were adsorbed to the ionic and nonionic binding membranes cationic polysulfone and nitrocellulose, respectively. Results indicated that complete elution was readily achieved only when combinations of surfactants and binding membranes were matched (i.e., ionic-ionic or nonionic-nonionic).

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“…There is no standard test to evaluate barrier effectiveness of condoms to penetration by viruses, although several different test methods have been described (1-4, 6, 8, 10-16). This report describes a new method which combines (i) filling a condom with a buffer containing a challenge virus and submerging the condom in collection buffer to collect for assay any virus which may penetrate the condom (8) and (ii) controlling the transcondom pressure hydrostatically and restricting expansion of the condom with a restrainer (13). This new method is easy to use, utilizes readily available equipment, and yields quantitative data on viable-virus penetration.…”

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confidence: 99%