BD 446250 - Affirm VPIII Collection Set, 24 Tests, Vaginitis DNA Probe Test for Vaginal Pathogens,EA
The BD 446250 - BD Affirm VPIII Collection Set is a diagnostic system specifically designed for the qualitative detection and identification of the three most common causes of vaginitis:Gardnerella vaginalis,Trichomonas vaginalis, andCandida species. Developed by Becton Dickinson (BD), this molecular hybridization-based DNA probe test provides accurate, dependable results directly from vaginal specimens. Each kit includes 24 complete collection sets, offering all necessary components for specimen collection, transport, and testing. The system is intended for use with the BD Affirm VPIII Microbial Identification Test platform, ensuring consistent and rapid identification of vaginal pathogens in clinical and diagnostic laboratory environments.
The Affirm VPIII test combines BDs trusted nucleic acid hybridization technology with a simple workflow, giving clinicians the confidence to deliver fast, evidence-based treatment decisions for patients presenting with symptoms of vaginitis or vaginosis.
| Manufacturer | 446250 |
| Application | Sexual Health Test Kit |
| CLIA Classification | CLIA Moderate Complexity |
| Contents 1 | Probe Analysis Cards (PAC) Individually Wrapped Containing (5) Beads (Negative Control, Trichomonas, Gardnerella, Candida, and Positive Control), Reagent Cassettes Containing Patient Sample Reservoir, Hybridization Solution, Wash Solution, Conjugate and Substrate Buffer |
| Specialty | Microbiology |
| Test Type | Microbial Identification |
Key Benefits
The BD Affirm VPIII Collection Set delivers several critical advantages in clinical diagnostics. It detects the most frequent infectious agents responsible for vaginitis with high sensitivity and specificity, reducing the likelihood of false positives or negatives. Results are typically available within 45 minutes, enabling same-day diagnosis and treatment initiation. The closed, self-contained test design minimizes contamination risk, while the included transport system preserves sample integrity during transfer. By providing a reliable, non-culture-based diagnostic solution, the BD Affirm VPIII supports improved patient outcomes, faster recovery, and reduced use of unnecessary or inappropriate antibiotics.
Compatibility and Applications
The BD 446250 Collection Set is designed for use exclusively with the BD Affirm VPIII Microbial Identification System. It is compatible with standard clinical laboratory workflows and can be integrated into microbiology departments, womens health clinics, and hospital diagnostic laboratories. Typical applications include the identification of pathogens responsible for bacterial vaginosis, vulvovaginal candidiasis, and trichomoniasis in symptomatic women. The test is particularly valuable for distinguishing between infectious and non-infectious causes of vaginitis, helping clinicians target therapy effectively.
Usage Guidelines
To perform testing, collect a vaginal specimen using the swab provided in the collection set. Insert the swab into the Affirm transport tube containing the preservative reagent and cap securely. Specimens should be processed within the time frame recommended by BD to ensure result accuracy. In the laboratory, the specimen is transferred to the BD Affirm VPIII Analyzer following the manufacturers instructions. The analyzer identifies hybridization between specific DNA probes and target organisms, displaying results forGardnerella,Trichomonas, andCandidawithin approximately 45 minutes. Detailed step-by-step procedures and quality control information are included in the kit insert.
Certifications, Safety Standards, and Regulatory Approvals
The BD Affirm VPIII Collection Set is FDA-cleared for in vitro diagnostic use and meets CLIA (Clinical Laboratory Improvement Amendments) requirements for moderate-complexity testing. BDs manufacturing processes comply with ISO 13485 standards, ensuring consistent quality, accuracy, and safety. The system is also CE-marked for distribution in international markets. All reagents and collection materials are sterile and designed for single-use only to prevent cross-contamination and maintain clinical reliability.
Comparison with Competitor Products
Compared to traditional wet-mount microscopy and culture methods, the BD Affirm VPIII system provides a faster, more precise molecular approach to vaginitis diagnosis. While culture-based tests may take several days, Affirm delivers accurate results in less than one hour. Competitor DNA probe or molecular assays may require specialized laboratory equipment or complex workflows, whereas the BD Affirm VPIII offers a simplified, self-contained system that integrates easily into routine laboratory operations. Its simultaneous detection of three pathogens in one assay gives it a competitive advantage over tests requiring separate samples for each organism.
Typical User Profile and Application Scenarios
The BD Affirm VPIII Collection Set is intended for use by healthcare professionals, including gynecologists, obstetricians, nurses, and clinical laboratory scientists. It is ideal for use in womens health clinics, sexually transmitted infection (STI) screening centers, hospital microbiology labs, and diagnostic testing facilities. It is particularly suited for evaluating patients presenting with symptoms such as vaginal discharge, itching, odor, or irritationallowing rapid and reliable differentiation among bacterial, fungal, or protozoal infections.
Best Practices for Use and Maintenance
Store the collection kits at 225C (3677F) and protect them from direct sunlight or freezing. Always use sterile technique when collecting specimens, and follow all safety precautions outlined in the BD Affirm product insert. Ensure that specimens are transported promptly and processed within the validated time frame. Dispose of used materials as biohazard waste according to institutional and regulatory requirements. Perform routine quality control testing using positive and negative controls provided by BD or recommended in the systems documentation to verify assay performance.
Regulatory and Safety Information
The BD 446250 - BD Affirm VPIII Collection Set is FDA-cleared and CE-marked for in vitro diagnostic use. It complies with all applicable safety and quality regulations, including ISO 13485 certification. The kit is intended for professional use only and should be handled in accordance with universal biosafety precautions. The reagents are non-toxic when used as directed. Users should consult the Safety Data Sheet (SDS) for information regarding handling and disposal of chemical components. The Affirm system meets the performance and safety standards required for clinical diagnostic laboratories worldwide.
How to Order
To order the BD 446250 - BD Affirm VPIII Collection Set (24 Tests), add the product to your cart and complete the checkout process. CIA Medical provides fast, reliable delivery and competitive pricing for diagnostic laboratories and healthcare providers. For bulk purchases, volume discounts, or product assistance, contact CIA Medicals customer service at (312) 275-5850 or use the contact form on this page. Our experienced representatives are available to assist with product specifications, availability, and technical support.
