BD 446257 - Affirm VPIII DNA Probe Test Kit for Candida, Gardnerella vaginalis, and Trichomonas vaginalis (24 Tests), 120/BX

BD 446257 - Affirm VPIII DNA Probe Test Kit for Candida, Gardnerella vaginalis, and Trichomonas vaginalis (24 Tests), 120/BX

The BD 446257 Affirm VPIII Test Kit is a rapid, DNA probe-based diagnostic tool that enables qualitative detection and identification of three key pathogens responsible for vaginitis: Candida species, Gardnerella vaginalis, and Trichomonas vaginalis. This molecular diagnostic solution provides results in approximately 45 minutes, enhancing clinical decision-making and reducing the reliance on subjective methods like wet mounts or cultures. Each kit includes 24 individual test units, optimized for OB/GYN practices, womens health clinics, and hospital laboratories.

Key Benefits:

• Simultaneously detects three common infectious agents in one test: yeast (Candida), bacterial vaginosis (G. vaginalis), and trichomoniasis (T. vaginalis)

• Offers rapid, accurate diagnosis with a turnaround time under one hour

• Eliminates guesswork, improving treatment accuracy and reducing overprescription of antibiotics

• Does not require refrigerationambient storage simplifies logistics

• Clinically validated with high sensitivity and specificity for each pathogen

• Compatible with the Affirm VPIII Analyzer for easy, automated readouts

Compatibility and Applications:

• Works exclusively with the Affirm VPIII Ambient Temperature Analyzer

• Suitable for:

  • Vaginal swab specimens collected from symptomatic women

  • Use in clinical diagnostic laboratories, OB/GYN offices, and public health settings

• Applications include:

  • Routine womens health screenings

  • Diagnosis of vaginal discharge and infection

  • Rapid support for antimicrobial stewardship protocols

Usage Guidelines:

• Collect vaginal specimen with the Affirm Collection Kit

• Insert swab into the sample preparation device and follow BD protocol

• Place test cassette into the Affirm Analyzer for automated result reading

• Results available in ~45 minutes

• Store kits at 1530C (5986F); do not refrigerate or freeze

• Designed for professional use only in laboratory or clinical environments

Certifications, Safety Standards, and Regulatory Approvals:

• FDA-cleared for in vitro diagnostic use

• CE Marked for international use

• Complies with CLIA, ISO 13485, and CAP standards

• Backed by BDs quality and traceability controls

• Includes quality control materials for in-lab performance verification

Comparison with Competitor Products:

• Faster and more user-friendly than traditional culture or microscopy methods

• No refrigeration neededroom temperature storage simplifies inventory management

• Higher specificity than Gram stain methods

• Delivers actionable, pathogen-specific results, unlike broad-spectrum or symptom-based diagnoses

• More affordable and accessible than PCR panels for basic vaginitis detection

Typical User Profile and Application Scenarios:

• Used by:

  • OB/GYN physicians, nurse practitioners, medical technologists, public health workers

• Ideal for:

  • Symptomatic women presenting with abnormal vaginal discharge, itching, or odor

  • Walk-in clinics, urgent care, or outpatient womens health departments

  • Practices aiming to reduce antibiotic misuse through precision diagnostics

Best Practices for Use and Maintenance:

• Ensure staff is trained on Affirm Analyzer operations and interpretation

• Use within the expiration date and store in ambient conditions only

• Always use the BD Affirm Collection Kit to ensure compatibility

• Dispose of used cassettes and components in accordance with biohazard protocols

• Maintain and calibrate the Affirm Analyzer regularly for optimal performance

Regulatory and Safety Information:

• For in vitro diagnostic use only

• Single-use components; do not reuse or resterilize

• Proper clinical biosafety and disposal procedures must be followed

• Full regulatory compliance documentation included in the kit packaging

How to Order:
To purchase the BD 446257 Affirm VPIII DNA Probe Test Kit for Candida, G. vaginalis, and T. vaginalis (24 Count),

• Click Add to Cart to order securely through CIA Medical.

• For analyzer support, bulk pricing, or technical guidance, contact CIA Medical customer service at (312) 275-5850 or use the contact form on this page.