Rapid bacterial vaginosis test S0004

bacteriaTrichomonas vaginalisimmunoassay

Product overview
Rapid multi-parameter test kit for screening, aiding diagnosis and monitoring treatment of bacterial vaginosis (BV). Model S0007 evaluates six indicators: hydrogen peroxide (H2O2), sialidase (SA), leukocyte esterase (LE), Candida (CV), Trichomonas (TV) and pH using a vaginal secretion sample.

Principle

• H2O2: Peroxidase-mediated reaction produces nascent oxygen that oxidizes chromogen; color intensity correlates with H2O2 concentration.
• Sialidase (SA): Substrate BCIN is cleaved by sialidase producing indole derivatives that oxidize to blue; intensity correlates with sialidase activity.
• Leukocyte esterase (LE): BCIA substrate reacts with leukocyte esterase producing indole derivatives that oxidize to blue; intensity correlates with esterase activity.
• Candida (CV): NAG enzymatic activity releases nitrophenol producing yellow; intensity correlates with Candida-associated NAG activity.
• Trichomonas (TV): Specific proteolytic enzyme in Trichomonas hydrolyzes substrate producing light blue/blue; intensity correlates with organism quantity.
• pH: Acid–base indicator shows yellow/greenish‑yellow/green for pH ≤4.5 and greenish‑blue/blue for pH >4.5.

Procedure

• Read complete instructions before testing and do not open the sealed foil pouch until ready.
• Remove device from pouch. Use swab to sample vaginal secretion and swab the pH well 2–3 times; record color/pH.
• Place swab into extraction tube, add 12–14 drops of extraction solution and squeeze to ensure extraction.
• Dispense 2 drops of extracted specimen into each test well (H2O2, SA, LE, CV, TV).
• Add one drop of chromogenic reagent to the H2O2 well as directed.
• Incubate device at 42–45°C (incubator or water bath). Read results within 15 minutes; readings after 30 minutes are invalid.

Kit components / Notes

• Test device(s) sealed in foil pouches, extraction tubes, extraction solution, swabs, chromogenic reagent and instructions for use.
• Handle and dispose of clinical specimens according to local biosafety regulations.
• Follow incubation temperature and timing precisely to ensure valid results.
• Related item numbers: S0004 (BV based on four indicators: H2O2, SA, LE, pH), S0007 (six indicators: H2O2, SA, LE, pH, CV, TV); other variants: S0005, S0006.

Sexually transmitted disease tests (selection)

• Neisseria gonorrhoeae: Item S0001 / SNG-502 — antigen/enzyme-based detection (urine, cervical/urethral secretion).
• Bacterial vaginosis: Item S0004 / S0007 — BV detection based on indicated markers (vaginal secretion).

Characteristics / Technical specifications

• Intended use: Rapid screening, aid in diagnosis and treatment evaluation of bacterial vaginosis.
• Test parameters: H2O2, sialidase (SA), leukocyte esterase (LE), Candida (CV), Trichomonas (TV), pH.
• Specimen: Vaginal secretion (pH and secretion specimen).
• Sample preparation: Immerse swab in extraction tube; add 12–14 drops extraction solution; squeeze to extract.
• Sample volume: 2 drops of extracted specimen per test well.
• Chromogenic step: Add chromogenic reagent to H2O2 well as instructed.
• Incubation: 42–45°C (incubator or water bath).
• Reading time: Read within 15 minutes; invalid after 30 minutes.