H. pylori Ag Test is a rapid qualitative immunochromatographic test intended for professional in vitro diagnostics. It enables the detection of Helicobacter pylori bacterial antigens in a fecal sample.

Helicobacter pylori is a Gram-negative bacterium that infects the gastric mucosa and may be associated with gastrointestinal diseases such as non-ulcer dyspepsia, gastric and duodenal ulcers, and active gastritis. Detection of H. pylori antigens in stool can aid in the diagnosis of infection with this bacterium.

The test provides a result as early as 10 minutes after sample application. The result is presented qualitatively—in the form of test lines. The result should not be interpreted after 20 minutes.

This product is intended for professional use. This is a medical device. Use it in accordance with the instructions for use or the label.

Features

• Sample type: feces
• Quick and easy test procedure
• Specificity: 95.7%, sensitivity: 95.0%, accuracy: 95.4%
• High-quality product
• Fast results in just 10 minutes!
• Single-use packaging
• Product intended for professional use

Package Contents

• 1 test cassette in a foil pouch
• 1 sample collection tube with buffer
• 1 user manual

Application

• Rapid diagnosis of Helicobacter pylori infection: The test enables the qualitative detection of H. pylori antigens in a stool sample, which can aid in the initial diagnosis of infection.
• Support for the diagnosis of gastric and duodenal diseases: Helicobacter pylori may be associated with gastrointestinal diseases such as gastritis, gastric ulcers, and duodenal ulcers.
• Non-invasive stool test: The test detects H. pylori antigens without the need to collect a sample from the gastric mucosa.
• Support for medical decision-making: The test result can assist healthcare professionals in making further diagnostic or therapeutic decisions.
• Diagnosis of patients with suspected H. pylori infection: The test may be used as an initial screening test in patients with suspected Helicobacter pylori infection.
• Professional use: This product is intended for professional in vitro diagnostics and should be used in accordance with the instructions for use.

Product identification and responsible entities

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