BD 446257 - Affirm VPIII Microbial Identification, Candida Species/ Gardnerella Vaginalis/ Trichomonas Vaginalis, Vaginal Secretion Sample Test Kit, 120 tests/kit, 1 kit/ea (Item Requires Refrigeration) (Temp Sensitive; Non-Returnable) (Continental US Only)

BD 446257 - Affirm VPIII Microbial Identification, Candida Species/ Gardnerella Vaginalis/ Trichomonas Vaginalis, Vaginal Secretion Sample Test Kit, 120 tests/kit, 1 kit/ea (Item Requires Refrigeration) (Temp Sensitive; Non-Returnable) (Continental US Only)

TheBD 446257 Affirm VPIII Test Kitis a rapid,DNA probe-based diagnostic toolthat enablesqualitative detection and identification of three key pathogensresponsible for vaginitis:Candida species,Gardnerella vaginalis, andTrichomonas vaginalis. This molecular diagnostic solution provides results in approximately45 minutes, enhancing clinical decision-making and reducing the reliance on subjective methods like wet mounts or cultures. Each kit includes24 individual test units, optimized for OB/GYN practices, womens health clinics, and hospital laboratories.

Key Benefits:

• Simultaneously detectsthree common infectious agentsin one test: yeast (Candida), bacterial vaginosis (G. vaginalis), and trichomoniasis (T. vaginalis)

• Offersrapid, accurate diagnosiswith a turnaround time under one hour

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

• Does not require refrigerationambient storagesimplifies logistics

• Clinically validated withhigh sensitivity and specificityfor each pathogen

• Compatible with theAffirm VPIII Analyzerfor easy, automated readouts

Compatibility and Applications:

• Works exclusively with theAffirm 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 theAffirm 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 at1530C(5986F); do not refrigerate or freeze

• Designed forprofessional use onlyin laboratory or clinical environments

Certifications, Safety Standards, and Regulatory Approvals:

• FDA-clearedfor in vitro diagnostic use

• CE Marked for international use

• Complies withCLIA,ISO 13485, andCAPstandards

• Backed by BDs quality and traceability controls

• Includes quality control materials for in-lab performance verification

Comparison with Competitor Products:

• Faster and moreuser-friendly than traditional culture or microscopy methods

• No refrigeration neededroom temperature storagesimplifies 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 inambient conditions only

• Always use theBD Affirm Collection Kitto 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:

• Forin 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 theBD 446257 Affirm VPIII DNA Probe Test Kit for Candida, G. vaginalis, and T. vaginalis (24 Count),

• ClickAdd to Cartto order securely through CIA Medical.

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