6012, 6013 – Helicobacter pylori Antigen

Intended Purpose

The Helicobacter pylori Antigen is a qualitative immunoassay 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), a gram-negative spiral shaped microaerophilic bacterium that can colonize the human stomach, is a common bacterial cause of peptic ulcers. H. pylori can be effectively detected from stool (faecal) samples. The bacterial enzyme, urease, plays a pivotal role in the protection of H. pylori in the stomach from the fatal effect of gastric acid: This protection is achieved by incorporation into the gastric mucosa and the cleavage of urea to carbon dioxide and ammonia; the later which nullifies the gastric acid around the germ. H. pylori screening is essential in the diagnosis of stomach diseases, in that the bacterial infections is associated with stomach disorders characterized by elevated production of gastric acid; e.g. type B gastritis, about 75% of Ulcus ventriculi and almost all cases of Ulcus duodeni. Due to the chronic infections caused by H. pylori, it has been confirmed by the WHO (1944) to belong to the group of defined carcinogens, and accepted to be a high risk factor for the development of gastric malignomas and MALT lymphoma.

Product Specifications

Title Helicobacter pylori Antigen
Product code 6012 or 6013
Indication Infectious disease - Stool diagnostics
Description Enzyme immunoassay for the qualitative determination of Helicobacter pylori antigen in fecal specimens
Format Microtiter plate coated with monoclonal antibodies against Helicobacter pylori
Total incubation time 75 min.
Sample volume 50 µL diluted stool sample
No. of determinations 48 (45 x 1) or 96 (93 x 1) + 3 x Calibrators

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  SDS [REF 6012, 6013][eng]   SDS [REF 6012, 6013][deu]

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Current version of the instructions for use. The respective valid version for processing the test can be found in the product packaging.