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