The Affirm™ VPIII system uses industry-first DNA probe technology to detect three major vaginal infections — Bacterial Vaginosis, Vulvovaginal Candidiasis and Trichomonas Vaginalis — simultaneously from a single specimen in a fully automated, operator-independent workflow endorsed by the US CDC.
Vaginal infections affect hundreds of millions of women worldwide each year. Bacterial Vaginosis (BV), Vulvovaginal Candidiasis (VVC) and Trichomonas Vaginalis (TV) collectively account for the majority of symptomatic vaginal complaints, yet their clinical presentations frequently overlap, making accurate diagnosis on symptom assessment alone unreliable. The Affirm™ VPIII system was specifically designed to resolve this diagnostic challenge.
Technology Platform
The Affirm™ VPIII system employs nucleic acid hybridisation using species-specific DNA probes to simultaneously detect:
- Gardnerella vaginalis — the primary causative organism associated with Bacterial Vaginosis
- Candida species — the fungal pathogen responsible for Vulvovaginal Candidiasis
- Trichomonas vaginalis — the protozoan parasite causing trichomoniasis
Unlike conventional microscopy, which requires skilled personnel and is subject to significant inter-observer variability, the Affirm™ VPIII system delivers objective, instrument-read results within approximately 45 minutes of specimen receipt. The automated reading module eliminates subjective interpretation, ensuring consistent results regardless of operator experience.
Workflow and Ease of Use
The Affirm™ VPIII system is designed for integration into routine gynaecology outpatient or laboratory workflows without requiring a dedicated molecular biology laboratory or specialised containment infrastructure. Key operational features include:
- Simple swab-to-result workflow requiring minimal hands-on time
- No special laboratory environment requirements — suitable for use in OB/GYN outpatient departments and maternal and child health hospitals
- Automated instrument reading eliminates subjective interpretation
- Single-use reagent cartridge format minimises cross-contamination risk
- Results interpreted as positive, negative or equivocal with clear numeric cut-offs
CDC Endorsement and Clinical Guidelines
The Affirm™ VPIII system is referenced in US Centers for Disease Control and Prevention (CDC) Sexually Transmitted Infections Treatment Guidelines as an approved laboratory method for the diagnosis of BV, VVC and TV. This endorsement reflects the system’s demonstrated clinical performance across large multicentre validation studies and its established role in evidence-based clinical practice internationally.
“The ability to detect all three major vaginal pathogens from a single swab specimen, in a single test run, fundamentally changes the diagnostic paradigm for vaginal infection management — moving clinicians away from empirical treatment and towards precision-guided therapy.”
Mixed Infection Detection
One of the most clinically significant advantages of the Affirm™ VPIII system is its ability to identify mixed infections — cases in which a patient is simultaneously infected with two or more of the target pathogens. Studies indicate that mixed infections occur in 20–30% of symptomatic vaginal infection cases, yet are systematically underdiagnosed when single-pathogen testing methods are used.
Failure to identify a concurrent pathogen in a mixed infection frequently results in incomplete treatment, persistent or recurrent symptoms, and patient dissatisfaction. The Affirm™ VPIII system’s simultaneous tri-pathogen detection capability directly addresses this clinical risk.
Availability in the Greater Bay Area
Hong Kong Origins Investment Limited is the authorised distributor for the Affirm™ VPIII system across the Greater Bay Area. We provide full implementation support including instrument installation, staff training, quality control protocols and ongoing technical service.
For pricing information and availability, or to arrange a product demonstration at your facility, please contact our medical device specialists.