- An in vitro diagnostic quality control material used in clinical laboratories and medical offices, it verifies the technical precision and accuracy of visual, rapid lateral-flow pregnancy test systems
Uses
- Quality Assurance Testing:
- Formulated as an external quality control to verify the performance of matching diagnostic kits like the OSOM® hCG-Urine Test, OSOM® Card Pregnancy, and the OSOM® hCG Combo Test
- Accuracy Verification:
- Validates the visual and qualitative detection of Human Chorionic Gonadotropin (hCG) hormones before real patient urine specimens are evaluated
- Regulatory Compliance:
- Assists medical facilities in fulfilling mandatory clinical laboratory regulations (such as CLIA and general laboratory QA protocols) by proving operational accuracy
Features
- Dual-Vial Control Set:
- Packaged as a practical, paired set containing one 10 mL vial of Negative Control and one 10 mL vial of Positive Control
- Purified hCG Target:
- The Positive Control vial is spiked with 50–100 mIU/mL of purified hCG (3rd International Standard) to trigger clear diagnostic markers
- Saline-Based Matrix:
- Formulated within a stable saline solution rather than real human urine, reducing organic odor and biological handling risk during routine preparation
- Preservative Matrix:
- Compounded with 0.2% sodium azide to prevent bacterial contamination and preserve molecular shelf life
- Refrigerated Storage:
- Requires consistent upright storage at standard refrigerator parameters of 2°C–8°C (36°F–46°F) and must ship on ice to preserve formulation viability
Benefits
- Safeguards Against Diagnostic Errors:
- Helps clinical staff immediately identify faulty test strip batches, exposure damage, or user procedural mistakes before executing patient assessments
- Pre-Rendered Convenience:
- Supplied ready-to-use in fluid form, mitigating manual measurement or volumetric math errors associated with lyophylized (dry) powders
- Clear Visual Baselines:
- Yields highly stark, predictable line readings on lateral-flow cassettes to establish an unambiguous benchmark for personnel interpretation
- Generous Bottle Volume:
- The 10mL vials provide a high volume of drops, making it highly cost-effective for smaller clinics maintaining a weekly or daily QC schedule
