- A rapid, point-of-care infectious disease immunoassay designed to detect Helicobacter pylori antibodies in human specimens, it serves as a diagnostic aid for identifying the primary bacterial cause of chronic gastritis and peptic ulcer disease
Uses
- Active Infection Screening:
- Aids clinicians in diagnosing active H. pylori infections in patients presenting with persistent gastrointestinal issues like ulcers, stomach pain, or severe acid reflux
- Point-of-Care Testing:
- Used directly within physician offices, emergency clinics, and laboratories for rapid, on-site patient screening
- Multi-Sample Diagnostics:
- Accommodates variable sample collection methods by processing human whole blood, serum, or plasma specimens.
Features
- CLIA Waived Status:
- Certified as CLIA waived for whole blood testing, allowing it to be legally operated by clinical staff in diverse, non-laboratory medical settings
- High Clinical Accuracy:
- Delivers a 95.9% clinical sensitivity rating when benchmarked against traditional, invasive gold-standard biopsy/histology methods
- Comprehensive Kit Contents:
- Sold as a 25-test box containing 25 visual test devices, 25 capillary tubes, developer fluid solution, and an instructional guide
- Micro-Volume Sampling:
- Requires highly minimal sample quantities, taking only 10μL for serum/plasma or 25μL for standard whole blood
- Ambient Storage Requirements:
- Formulated for standard room temperature storage, removing the need for refrigeration space
Benefits
- Rapid Diagnostic Speed:
- Produces clear, readable results in 10 minutes or less, significantly accelerating patient evaluation and treatment timelines
- Simplified Three-Step Workflow:
- Requires no specialized instrumentation, relying on a basic three-step application and a single, included reagent bottle
- Unambiguous Visual Readout:
- Uses stark, color-coded lines at designated Control (C) and Test (T) slots to prevent interpretation errors during manual reading
