Affirm™ VPIII Vaginal Infections Microbial Detection System

Medical Devices · Women's Health · DNA Probe Technology · CFDA Registered

Affirm™ VPIII Vaginal Infections Microbial Detection System

The Affirm™ VPIII is the industry's first fully automated system using DNA probe technology to simultaneously detect the three most common vaginal pathogens — Bacterial Vaginosis (BV), Vulvovaginal Candidiasis (VVC) and Trichomonas Vaginalis (TV) — from a single sample. It has become the standard method for vaginal infection testing recommended by the US Centers for Disease Control and Prevention (CDC).

  • Detects BV, VVC and TV simultaneously from one sample
  • Industry-first DNA probe technology — direct pathogen nucleic acid detection
  • Dual-probe molecular detection for enhanced sensitivity
  • Fully automated processing and result interpretation — no subjective reading
  • No special lab environment required — suitable for OB/GYN rapid diagnostics
  • Standard method endorsed by the US CDC

Why Affirm™ VPIII?

Vaginal infections affect virtually every woman at some point in life. Bacterial vaginosis, candidiasis and trichomoniasis — the three most prevalent vaginal infections — frequently occur as mixed infections, meaning that targeting only one pathogen leaves the underlying condition untreated and leads to recurrence.

Conventional diagnosis often relies on microscopic wet-mount examination, which is highly dependent on the skill and subjective judgment of the observer, and is vulnerable to sample instability during transport. Affirm™ VPIII addresses these limitations by using patented DNA probe technology to directly detect pathogen nucleic acids, providing objective, reproducible results unaffected by sample handling conditions or mixed infection interference.

How It Works

  • Single vaginal swab sample collected at point of care
  • DNA probe hybridisation directly targets pathogen nucleic acids
  • Fully automated sample handling, processing and result reading
  • Clear positive/negative results for each of the three pathogens
  • Results unaffected by mixed infections, sample contamination or transport conditions

Clinical Benefits

  • Eliminates misdiagnosis caused by single-pathogen testing
  • Enables evidence-based, targeted treatment from first consultation
  • Reduces recurrence rates by identifying mixed infection profiles
  • Streamlines OB/GYN outpatient workflow with rapid, same-visit results
Affirm™ VPIII Vaginal Infections Microbial Detection System

Source: CFDA Clinical Trial Registration Data

Pathogen Method Sensitivity Specificity Reference Standard
Bacterial Vaginosis (BV) Affirm VPIII 93.55% 83.15% Nugent Score / Amsel criteria
Bacterial Vaginosis (BV) Amsel Criteria 51.61% 100% Reference
Vulvovaginal Candidiasis (VVC) Affirm VPIII 89.4% 98.3% Culture / Microscopy
Vulvovaginal Candidiasis (VVC) Microscopy 76.9% 97.1% Reference
Trichomonas Vaginalis (TV) Affirm VPIII 92.86% 100% Culture / Microscopy
Trichomonas Vaginalis (TV) Microscopy 78.57% 100% Reference

Affirm™ VPIII consistently outperforms conventional microscopy in sensitivity for all three pathogens, while maintaining high specificity — making it the clinically superior choice for accurate first-visit diagnosis and appropriate treatment selection.

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