6012, 6013 – Helicobacter pylori Antigen

Highlights

• Use of monoclonal antibodies specific for Helicobacter pylori antigen
• Ready-to-use reagents (exception: wash buffer)
• High diagnostic relevance for gastritis, peptic ulcer disease, and H. pylori–associated gastric disorders
• Uses monoclonal antibodies for specific antigen detection
• Suitable for initial screening and therapy monitoring
• Reliable and reproducible results for routine laboratory diagnostics
• Manual, professional in vitro diagnostic use
• CE marked

Intended Use

The Helicobacter pylori Antigen is a qualitative enzyme-linked immunosorbent assay (ELISA) for the determination of Helicobacter pylori antigen in fecal specimens. The Helicobacter pylori Antigen is intended as an aid in the diagnosis of Helicobacter pylori infections in conjunction with other clinical and laboratory findings. The immunoassay is designed for manual professional in vitro diagnostic use.

Diagnostic Relevance

Helicobacter pylori (H. pylori) is a gram-negative, spiral-shaped, microaerophilic bacterium capable of colonizing the human stomach and represents one of the most common bacterial causes of peptic ulcer disease. Detection of H. pylori from stool (fecal) samples provides a non-invasive and direct diagnostic approach.

A key survival mechanism of H. pylori in the acidic gastric environment involves the bacterial enzyme urease. By catalyzing the cleavage of urea into ammonia and carbon dioxide, urease locally neutralizes gastric acid and enables bacterial persistence within the gastric mucosa. Consequently, H. pylori infections show a strong association with gastric disorders characterized by increased acid production, including type B gastritis, approximately 75% of Ulcus ventriculi cases, and nearly all cases of Ulcus duodeni.

Chronic H. pylori infection represents a significant risk factor for the development of severe gastric diseases. The World Health Organization classified H. pylori as a group I carcinogen in 1994, acknowledging its established role in the development of gastric carcinoma and mucosa-associated lymphoid tissue (MALT) lymphoma. Early detection and monitoring of H. pylori therefore play a critical role in the diagnosis and management of gastric pathologies.