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PCR-based method for detecting viral penetration of medical exam gloves
John M Broyles1, Kevin P O'Connell, Denise M Korniewicz
1Department of Adult Health Nursing, School of Nursing, University of Maryland, Baltimore 21201, USA.
Abstract:
The test approved by the U.S. Food and Drug Administration for assessment of the barrier quality of medical exam gloves includes visual inspection and a water leak test. Neither method tests directly the ability of gloves to prevent penetration by microorganisms. Methods that use microorganisms (viruses and bacteria) to test gloves have been developed but require classical culturing of the organism to detect it. We have developed a PCR assay for bacteriophage phiX174 that allows the rapid detection of penetration of gloves by this virus. The method is suitable for use with both latex and synthetic gloves. The presence of glove powder on either latex or synthetic gloves had no effect on the ability of the PCR assay to detect bacteriophage DNA. The assay is rapid, sensitive, and inexpensive; requires only small sample volumes; and can be automated.
Insights
A new PCR assay rapidly detects virus penetration through medical gloves, offering a sensitive and inexpensive alternative to current testing methods. This advancement improves the assessment of barrier integrity for both latex and synthetic gloves.
Area of Science:
- Microbiology
- Biotechnology
- Medical Device Testing
Background:
- Current U.S. Food and Drug Administration-approved tests for medical examination gloves, including visual inspection and water leak tests, do not directly assess microbial penetration.
- Existing methods using microorganisms to test glove integrity require time-consuming classical culturing for detection.
Purpose of the Study:
- To develop a rapid, sensitive, and cost-effective assay for detecting microbial penetration through medical examination gloves.
- To evaluate the efficacy of a Polymerase Chain Reaction (PCR) assay for detecting bacteriophage phiX174 penetration in various glove materials.
Main Methods:
- Development and validation of a PCR assay targeting bacteriophage phiX174 DNA to detect viral penetration.
- Testing the assay's performance with both latex and synthetic gloves, with and without glove powder.
- Comparison of the PCR assay's speed, sensitivity, and cost-effectiveness against traditional culturing methods.
Main Results:
- The developed PCR assay successfully and rapidly detected the penetration of bacteriophage phiX174 through medical examination gloves.
- The assay demonstrated effectiveness with both latex and synthetic glove materials.
- Glove powder did not interfere with the PCR assay's ability to detect viral DNA.
Conclusions:
- The PCR assay provides a rapid, sensitive, inexpensive, and automatable method for assessing the microbial barrier quality of medical gloves.
- This assay offers a significant improvement over existing methods by directly detecting viral penetration.
- The method is suitable for quality control and research applications in medical glove manufacturing and testing.