- An in vitro diagnostic quality control material used in clinical laboratories and point-of-care facilitie, it verifies the precision, accuracy, and functionality of diagnostic systems designed to detect pregnancy
Uses
- Quality Control Validation:
- Actively monitors, tests, and validates the performance of the OSOM® Ultra hCG Combo Test Kit
- Pregnancy Assay Verification:
- Confirms the analytical qualitative detection of human chorionic gonadotropin (hCG) hormones in human specimens
- Regulatory Compliance:
- Satisfies mandatory clinical lab validation protocols (like CLIA and QA standards) by proving diagnostic accuracy before patient samples are processed
Features
- Dual-Vial Control Configuration:
- Packaged as a combined set containing one 5mL vial of hCG Positive Serum Control and one 5mL vial of hCG Negative Serum Control
- Human Serum Matrix:
- Formulated from a processed human serum base to perfectly mimic human clinical samples for realistic immunoassay reactions
- Pre-Rendered Liquid Format:
- Supplied ready-to-use in liquid form, completely removing any risks of measurement errors during reconstitution
- Refrigerated Stability:
- Specifically manufactured for stable upright storage under standard refrigeration protocols, requiring shipment on ice to preserve protein integrity
Benefits
- Safeguards Patient Diagnostics:
- Prevents false clinical readings by catching corrupted cassette batches, environmental damage, or user errors before live testing
- Streamlines Clinical Workflows:
- Eliminates manual formulation, chemical mixing, and preparation steps, keeping rapid testing swift and easy
- Ensures High Analytical Trust:
- Maximizes confidence in pregnancy testing pipelines, aligning with the assay's ability to detect deep beta-core fragments and variants without biotin interference
- Generates Crisp Visual Anchors:
- Yields clear, stark positive or negative visual markers on matching lateral-flow cassettes to eliminate clinical interpretation bias
