CTK OnSite® H. pylori Ag Rapid Test CE, Stool

The OnSite® H. pylori Ag Rapid Test is a lateral flow chromatographic immunoassay designed for the qualitative detection of Helicobacter pylori antigen in human fecal specimens. This noninvasive antigen detection test provides results in just 10 minutes, enabling rapid screening for active H. pylori infection at the point of care without the need for specialized equipment or laboratory facilities.

The test delivers high clinical performance with 100% sensitivity and 98.5% specificity, and has demonstrated no cross-reactivity with over 50 gastrointestinal pathogens. Additionally, it shows no interference with commonly encountered antacids, gastrointestinal medications, or stool conditions, ensuring reliable performance in real-world clinical scenarios.

Key Features

• Specimen Type: Human fecal specimens.
• Ease of Use: Simple sample collection and testing procedure.
• Fast Results: Results available in 10 minutes.
• Reliable Performance:
  • Sensitivity: 100% (95% CI: 92.0%–100%)
  • Specificity: 98.5% (95% CI: 94.8%–99.6%)
• No Cross-Reactivity: Verified against more than 50 gastrointestinal pathogens.
• Interference-Free: Stable performance even in the presence of antacids (Tums®, Pepto-Bismol®, Tagamet®, Prilosec®, Mylanta®), barium sulfate, or tarry stool.
• External Controls: Facilitates internal laboratory quality assurance.
• Shelf Life: 24 months at 2–30 °C.

Clinical Performance

• Positive Percent Agreement (PPA/Relative Sensitivity): 100%
• Negative Percent Agreement (NPA/Relative Specificity): 98.5%
• Cross-Reactivity: None with 50+ GI pathogens.
• Interference Testing: No interference from common GI drugs, barium sulfate, or blood in stool.

Kit Contents

• Individually sealed foil pouches containing test cassettes with desiccants
• Sample collection devices (as provided per kit format)
• Instructions for use

Applications

• Clinical Diagnostics: Rapid noninvasive detection of active H. pylori infections.
• Gastroenterology Clinics: On-site screening of patients with suspected peptic ulcer disease or gastritis.
• Public Health Programs: Population-level screening in high-incidence regions.
• Point-of-Care Testing: Fast diagnosis in hospitals, clinics, and field settings.

The OnSite® H. pylori Ag Rapid Test (R0192C) is a fast, accurate, and user-friendly solution for the detection of H. pylori antigen in fecal specimens. With its excellent sensitivity, specificity, and robustness against common interferences, it is well-suited for use in clinical, point-of-care, and public health settings. Its noninvasive nature and rapid turnaround make it a valuable tool for the diagnosis and management of H. pylori infections.