6110 – Helicobacter Antigen Quick

Highlights

• Use of highly specific monoclonal antibodies for rapid detection of Helicobacter pylori antigens in human stool specimens
• Supports the diagnosis of Helicobacter-related gastrointestinal infections, including gastritis and peptic ulcers
• Qualitative rapid immunochromatographic test with visual readout for quick results
• Ready-to-use test strips with color-coded antibodies and integrated controls for reliable interpretation
• Manual procedure optimized for professional in vitro diagnostic use
• Non-invasive testing without the need for endoscopy or specialized instrumentation
• Easy handling and fast results, enabling prompt clinical decision-making
• Kit includes 25 test strips, 3 × 10 mL sample diluent, and instructions for use
• Suitable for routine laboratory workflows, with simple sample preparation and storage at 2 °C to 30 °C
• Provides a sensitive, cost-effective, and convenient alternative for direct detection of H. pylori antigen
• CE marked

Intended Use

The Helicobacter Antigen Quick is a qualitative rapid  immunoassay designed for the detection of Helicobacter pylori antigen in human stool specimens. The test provides a reliable aid in the diagnosis of infectious gastroenteritis, delivering timely information to complement clinical assessment and laboratory findings. Its manual procedure is simple and optimized for routine use, producing consistent and accurate results without the need for specialized instruments or invasive techniques. The immunoassay is designed for manual professional in vitro diagnostic use.

Diagnostic Relevance

Helicobacter pylori (H. pylori) is a spiral-shaped bacterium that colonizes the human stomach and duodenum, adapting to the highly acidic gastric environment. The bacterium produces the enzyme urease, which converts urea into ammonia and carbon dioxide, neutralizing stomach acid and allowing H. pylori to survive and proliferate. Since its discovery in 1984 by Marshall and Warren, H. pylori has been established as the primary causative agent of gastritis, peptic ulcers, and gastric carcinoma.

Infections typically occur during early childhood and persist unless treated. Epidemiological studies show that H. pylori causes over 90% of duodenal ulcers and 80% of gastric ulcers. Infection rates vary globally, with approximately 30–40% in Europe and up to 50% worldwide. Rates in developed countries have declined due to improved hygiene and effective therapeutic regimens, whereas developing regions continue to experience high prevalence.

Direct detection of H. pylori antigen in stool samples using a rapid, one-step immunoassay offers a sensitive, non-invasive, and cost-effective alternative to endoscopy or other invasive diagnostic procedures. Early and accurate detection supports timely clinical intervention, monitoring of eradication therapy, and prevention of serious gastrointestinal complications.