BD 446251 - Affirm Collection Swab for VP III Sample Test, Bulk Pack Sterile Swab System for Vaginal Pathogen Collection, 100/Pk
The BD 446251 - BD Affirm Collection Swab for VP III Sample Test (Bulk Pack) is a high-quality, sterile specimen collection device designed specifically for use with the BD Affirm VPIII Microbial Identification System. Manufactured by Becton Dickinson (BD), these swabs are optimized for collecting, transporting, and processing vaginal specimens for the qualitative detection of key pathogens, including Gardnerella vaginalis, Candida species, and Trichomonas vaginalis.
Each swab is engineered with precision to ensure efficient sample uptake and release, maintaining specimen integrity for accurate nucleic acid hybridization-based testing. The bulk pack configuration provides cost-effective and convenient access for laboratories performing high-volume diagnostic screening.
Key Benefits
The BD Affirm Collection Swabs deliver consistent, contamination-free specimen collection and transport. Key advantages include:
- Optimized compatibility: Designed exclusively for use with the BD Affirm VPIII Identification System.
- Reliable sample integrity: Maintains microorganism viability and nucleic acid stability from collection to testing.
- Sterile, single-use design: Prevents cross-contamination and ensures aseptic handling.
- Bulk packaging: Ideal for high-throughput laboratories, reducing unit cost and waste.
- Convenient handling: Ergonomically designed shaft and tip for comfortable and effective specimen collection.
Compatibility and Applications
The BD 446251 Affirm Collection Swabs are fully compatible with the BD Affirm VPIII Microbial Identification System and related reagents. They are specifically designed for clinical diagnostic use in:
- Gynecology and obstetrics clinics collecting vaginal swab specimens.
- Clinical microbiology laboratories performing Affirm VPIII tests.
- Public health and womens health programs conducting large-scale pathogen screening.
- Diagnostic testing centers processing specimens for Gardnerella, Candida, and Trichomonas.
These swabs support accurate and rapid diagnosis of bacterial vaginosis, candidiasis, and trichomoniasis.
Usage Guidelines
Collect specimens according to BD Affirm VPIII collection protocol. Using aseptic technique, insert the sterile swab into the vaginal canal and rotate gently to collect epithelial and discharge material. Immediately transfer the swab to the Affirm transport system or designated test tube, ensuring it is securely capped. Label appropriately and transport to the laboratory as soon as possible, maintaining storage conditions recommended in the BD Affirm VPIII instructions. Do not reuse swabs or use if packaging is damaged or expired.
Certifications, Safety Standards, and Regulatory Approvals
The BD Affirm Collection Swabs are CE-marked and FDA-cleared for in vitro diagnostic (IVD) use. They are produced under ISO 13485:2016-certified quality management systems and comply with CLSI and FDA specimen collection and transport standards. Each lot is tested for sterility, absorbency, and recovery efficiency to ensure optimal performance with the BD Affirm VPIII assay. The swabs are latex-free, DEHP-free, and non-pyrogenic.
Comparison with Competitor Products
Compared to generic specimen collection swabs, BD Affirm Collection Swabs offer superior compatibility and performance within BDs hybridization-based diagnostic workflow. While other swabs may not maintain nucleic acid integrity or may cause inhibition during testing, BDs design ensures consistent recovery and accurate hybridization results. The bulk pack format further reduces per-test cost, making it ideal for laboratories processing high specimen volumes.
Typical User Profile and Application Scenarios
This product is designed for use by healthcare and laboratory professionals including nurses, clinicians, and laboratory technologists in:
- Hospitals and gynecological clinics performing vaginal pathogen testing.
- Reference and diagnostic laboratories using the BD Affirm VPIII System.
- Public health screening programs for womens reproductive health.
- Private laboratories conducting high-volume sexually transmitted infection (STI) diagnostics.
It is an essential component of the BD Affirm workflow for rapid, accurate pathogen identification in vaginal specimens.
Best Practices for Use and Maintenance
Store the BD Affirm Collection Swabs at 1530C in their original packaging until use. Do not expose to moisture, heat, or direct sunlight. Maintain aseptic technique throughout specimen collection and transport. Do not use swabs beyond their expiration date or if the sterile pouch is damaged. Always dispose of used swabs and packaging in accordance with institutional biohazard waste protocols.
Regulatory and Safety Information
The BD 446251 - BD Affirm Collection Swab for VPIII Sample Test is compliant with FDA, CE, and ISO 13485 medical device regulations. The product is sterile, non-toxic, and biocompatible, ensuring patient and user safety. A Certificate of Analysis (CoA) and Safety Data Sheet (SDS) are available upon request from BD. The product is intended strictly for professional use in clinical and laboratory environments by trained personnel following BDs validated testing procedures.
How to Order
To order the BD 446251 - BD Affirm Collection Swab for VPIII Sample Test (Bulk Pack), add the item to your cart and complete checkout through CIA Medical. We offer competitive pricing, reliable shipping, and full support for clinical laboratories and healthcare facilities. For bulk orders, Certificates of Conformance, or technical documentation, contact CIA Medicals customer service team at (312) 275-5850 or use the contact form on this page. Our representatives can assist with product specifications, test compatibility, and availability details.
