6110 – Helicobacter Antigen Quick

Intended Purpose

The Helicobacter Antigen Quick is a qualitative immunoassay for the determination of Helicobacter pylori antigen in human stool specimens. The Helicobacter Antigen Quick intended as an aid in the diagnosis of infectious gastroenteritis 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 common bacterial cause of peptic ulcers, can be effectively detected from stool (faecal) samples. Identified as the causative agent of peptic ulcers, gastritis, and gastric carcinoma, the spiral-shaped bacterium colonizes human stomach and duodenum. The acidic nature of the stomach is neutralized by the enzyme urease, which transforms urea into ammonia and carbon dioxide; this enables the bacteria to adapt to this environment. Occurring usually in childhood, over 90% of duodenal ulcers and 80% of gastric ulcers are caused by H. pylori. Advanced health care systems and therapies in developed countries have reduced the rate of infections; however, the reverse is the case in many developing countries.

Product Specifications

Title Helicobacter Antigen Quick
Product code 6110
Indication Helicobacter pylori infections
Description Rapid immunochromatographic test for the detection of Helicobacter pylori antigen in human stool specimens
Format Test strips coated with monoclonal antibodies against Helicobacter pylori
Incubation time 5 min.
Sample volume 5 mm sample
No. of determinations 25 (25 x 1)

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  SDS [REF 6110][eng]   SDS [REF 6110][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.