BD 446252 - Affirm VPIII DNA Probe Microbial ID Test Kit, Qualitative, 24-Count, EA

BD 446252 - Affirm VPIII DNA Probe Microbial ID Test Kit, Qualitative, 24-Count, EA

TheBD 446252 Affirm VPIII DNA Probe Microbial Identification Test Kitis aqualitative in vitro diagnostic tooldesigned for therapid and accurate identification of vaginitis-causing pathogens. This test detects DNA fromCandida species,Gardnerella vaginalis, andTrichomonas vaginalisusingDNA probe hybridization technology. Each kit includes24 test units, ideal for clinical labs, OB/GYN clinics, and point-of-care settings requiring fast, reliable results with minimal sample handling.

Key Benefits:

• Simultaneously detects and differentiatesthree common vaginal pathogensin a single test

• Rapid turnaround timeimproves treatment decisions and reduces unnecessary antibiotic use

• Eliminates need for culture or wet mount techniques, improving diagnostic confidence

• Helps clinicians distinguish betweenbacterial vaginosis, candidiasis, and trichomoniasis

• Self-contained unit minimizes contamination risk and enhances ease of use

• Clinically validated to deliverhigh sensitivity and specificityfor each target organism

Compatibility and Applications:

• Compatible with theAffirm VPIII Ambient Temperature Analyzersystem

• Used for thequalitative detection of DNA targetsfrom 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 atroom temperature(1530C); do not freeze

• Forprofessional use onlyin CLIA-certified or equivalent laboratories

Certifications, Safety Standards, and Regulatory Approvals:

• FDA-clearedfor clinical diagnostic use

• Compliant withCLIA and CAPlaboratory testing standards

• Manufactured underISO 13485quality management certification

• CE Marked for international markets

• Quality control materials available for internal performance monitoring

Comparison with Competitor Products:

• Offersfaster resultscompared 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 seekingaccurate, immediate resultsin 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 theexpiration datebefore 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:

• Forin 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 theBD 446252 Affirm VPIII DNA Probe Microbial Identification Test Kit (24 Count),

• ClickAdd to Cartto place a secure order via CIA Medical.

• For clinical consultation, volume pricing, or analyzer compatibility questions, contactCIA Medical customer serviceat(312) 275-5850or use the contact form on this page.