- A specialized, liquid quality control package designed to verify the performance, accuracy, and reagent reliability of Quidel’s pregnancy rapid test diagnostic lines
Uses
- External Validation Testing:
- Acts as a proxy for patient samples to verify that rapid pregnancy test strips are chemically responsive and working correctly
- System Component Isolation:
- Engineered explicitly to validate three main pregnancy kits: QuickVue One-Step hCG Urine (20109), QuickVue One-Step hCG Combo (20110), and the QuickVue+ One-Step hCG Combo
- Regulatory Compliance:
- Fulfills required periodic external quality assurance audits under CLIA and local laboratory regulation protocols
- Personnel Training Verification:
- Evaluates and logs the visual reading accuracy and performance technique of laboratory staff members
Features
- Dual-Level Liquid Architecture:
- Contains two separate 4.5 mL dropper vials to isolate baseline target reactions
- Positive Control Vial (1 x 4.5mL):
- Pre-formulated with a buffered human Chorionic Gonadotropin (hCG) solution to simulate an active pregnancy sample
- Negative Control Vial (1 x 4.5mL):
- Pre-formulated with a baseline buffered solution containing zero detectable hCG hormone molecules to confirm the strip does not false-trigger
- High Testing Capacity Yield:
- Delivers an estimated 23 to 31 distinct quality control tests out of each standalone bottle
- In Vitro Diagnostic (IVD) Labeling:
- Certified specifically for medical, laboratory, and professional healthcare environments
- Shelf-Stable Room Temperature Storage:
- Requires zero dedicated laboratory refrigerator space, keeping stable at standard room temperatures
Benefits
- Guarantees Diagnostic Confidence:
- Eliminates medical staff uncertainty by verifying the test strips are physically intact before evaluating real patient urine samples
- Flags Degraded Reagents:
- Catches compromised or expired test kit shipments (damaged by severe heat or freezing during transport) before they generate false patient results
- Streamlined Quality Audits:
- Includes an official clinical package insert instruction guide to easily document, track, and log control metrics during facility inspections
- Optimized Clinic Savings:
- Allows busy healthcare providers to purchase independent liquid validation materials separately without replacing expensive, full diagnostic cassettes
