BD 446252 - Affirm VPIII DNA Probe Microbial ID Test Kit, Qualitative, 24-Count, EA
The BD 446252 Affirm VPIII DNA Probe Microbial Identification Test Kit is a qualitative in vitro diagnostic tool designed for the rapid and accurate identification of vaginitis-causing pathogens. This test detects DNA from Candida species, Gardnerella vaginalis, and Trichomonas vaginalis using DNA probe hybridization technology. Each kit includes 24 test units, ideal for clinical labs, OB/GYN clinics, and point-of-care settings requiring fast, reliable results with minimal sample handling.
| Manufacturer | 446252 |
| Application | Sexual Health Test Kit |
| CLIA Classification | CLIA Non-Waived |
| CLIA Classified | CLIA Non-Waived |
| Contents 1 | (24) Probe Analysis Cards, (24) Reagent Cassettes, 3.4 mL Substrate Solution, 10.8 mL Lysis Solution, 15 mL Buffer Solution, (24) Filter Tips, (24) Sample Collection Cups, (24) Sample Collection Tubes, (24) Sterile Swabs |
| Specialty | Microbiology |
| Test Format | Test Card Format |
| Test Kit Type | Standard |
Key Benefits:
Simultaneously detects and differentiates three common vaginal pathogens in a single test
Rapid turnaround time improves treatment decisions and reduces unnecessary antibiotic use
Eliminates need for culture or wet mount techniques, improving diagnostic confidence
Helps clinicians distinguish between bacterial vaginosis, candidiasis, and trichomoniasis
Self-contained unit minimizes contamination risk and enhances ease of use
Clinically validated to deliver high sensitivity and specificity for each target organism
Compatibility and Applications:
Compatible with the Affirm VPIII Ambient Temperature Analyzer system
Used for the qualitative detection of DNA targets from vaginal swab specimens
Applicable in:
OB/GYN clinics
Hospital microbiology labs
Womens health practices
Public health screening programs
Usage Guidelines:
Collect vaginal swab specimen using the Affirm sample collection system
Place the swab into the test kit reagent container and follow manufacturer instructions
Insert cassette into the Affirm analyzer and read results within 45 minutes
Store kit at room temperature (1530C); do not freeze
For professional use only in CLIA-certified or equivalent laboratories
Certifications, Safety Standards, and Regulatory Approvals:
FDA-cleared for clinical diagnostic use
Compliant with CLIA and CAP laboratory testing standards
Manufactured under ISO 13485 quality management certification
CE Marked for international markets
Quality control materials available for internal performance monitoring
Comparison with Competitor Products:
Offers faster results compared to culture-based or Gram stain diagnostics
No refrigeration required, unlike some PCR-based kits
Pre-packaged and ready-to-use components reduce operator error and variability
High throughput and efficiency ideal for busy womens health practices
Preferred choice for clinicians seeking accurate, immediate results in diagnosing vaginal infections
Typical User Profile and Application Scenarios:
Used by:
OB/GYNs, nurse practitioners, lab technicians, primary care physicians
Application scenarios:
Evaluation of vaginal discharge symptoms
Differential diagnosis for vaginal infections
Support for antimicrobial stewardship and appropriate therapy selection
Best Practices for Use and Maintenance:
Always verify the expiration date before use
Handle test cassettes and reagents with clean gloves and follow aseptic technique
Do not reuse test components; dispose of used materials per clinical biohazard policy
Perform regular QC testing with provided control materials to ensure accurate results
Train all users according to manufacturer protocols to ensure consistency and accuracy
Regulatory and Safety Information:
For in vitro diagnostic use only
Single-use device; not to be reused or resterilized
Store at recommended conditions to maintain assay integrity
Follow local and federal regulations for disposal of biological waste and diagnostic materials
How to Order:
To purchase the BD 446252 Affirm VPIII DNA Probe Microbial Identification Test Kit (24 Count),
Click Add to Cart to place a secure order via CIA Medical.
For clinical consultation, volume pricing, or analyzer compatibility questions, contact CIA Medical customer service at (312) 275-5850 or use the contact form on this page.
