- A refrigerated external quality control kit used in clinical laboratories and near-patient point-of-care (POC) settings, it provides pre-measured reference solutions specifically designed to verify the performance accuracy of the OSOM® BVBLUE® Rapid Test, which detects bacterial vaginosis (BV)
Uses
- Quality Control Verification:
- Functions as the official external reference standard to test both the reactive chemicals in the assay and individual operator technique
- Regulatory and CLIA Compliance:
- Deployed by medical facilities to fulfill local and federal laboratory compliance regulations (such as CLIA regulations for waived or moderately complex tests) which require regular documentation of diagnostic test reliability
- Troubleshooting and Assay Validation:
- Used when a new testing kit lot is opened, when storage temperature bounds have been exceeded, or when patient test results need internal verification
Features
- Dual-Level Reference Solutions:
- Each kit contains two distinct, pre-formulated vial solutions:
- (1) Positive Control Vial (5mL): Simulates sialidase enzyme activity to trigger a definitive visual color shift
- (1) Negative Control Vial (5mL): Lacks target markers to ensure no false baseline reactions occur
- Target Enzyme Simulation:
- Formulated to specifically interact with the enzymatic pathways used by the BVBLUE test to identify elevated sialidase activity produced by bacterial pathogens like Gardnerella, Bacteroides, Prevotella, and Mobiluncus
- Dedicated Cold Storage Handling:
- Requires constant refrigeration between 2–8°C (36–46°F) to protect the biological integrity of the positive enzyme controls
- Extended Open-Vial Longevity:
- Provides a stable 11-to-12-month shelf life from production when maintained under continuous refrigeration
- Included Documentation:
- Ships with a master directional insert outlining precise drop-volume instructions and target color-match charts
Benefits
- Ensures Diagnostic Accuracy:
- Guarding against faulty readings helps clinics confidently rule out false negatives and false positives, ensuring proper patient treatment pathways
- Instant, Objective Verification:
- Mirroring the actual test, it yields an immediate, unmistakable color shift, removing subjective interpretation or human guesswork from the validation process
- High-Yield Clinical Value:
- The 5mL bottle volumes deliver enough solution to perform 10 separate test cycles per kit, providing a cost-effective quality assurance setup for community health centers and OB-GYN clinics
- Seamless Protocol Pairing:
- Because it is engineered natively alongside the OSOM® BVBLUE® Rapid Test, it prevents chemical mismatches or irregular reactions caused by generic third-party controls
