BIOGEMA Helicobacter Pylori test 1pc

Product detailed description

Characteristics
Currently, 13 species have been described within the genus Helicobacter. The human pathogen is H. pylori. Helicobacter pylori is a spiral-shaped gram-negative bacterium that colonises the epithelium of the stomach and proximal duodenum. It is associated with various diseases of the digestive tract, such as acute and chronic gastritis, and adenocarcinoma of the stomach or duodenum. Culture and histological examinations have shown that up to 90% of patients with duodenal and gastric ulcers are infected with H. pylori. The HELICOBACTER PYLORI test is designed for the rapid, qualitative immunochromatographic detection of H. pylori of all isotypes in stool.

Storage
Store the HELICOBACTER PYLORI test at a temperature of 4 - 30°C, out of reach of children. Do not store the test in the freezer. Do not use
after the expiry date. 

Warning

• An in vitro diagnostic medical device intended for self-testing.
• The test cassette and extraction tube are for single use only.
• Before performing the test, read the procedure carefully.
• Pour any unused content from the tube down the sink.
• The extraction solution contains a preservative that may cause irritation on direct contact with the skin. In case of direct skin contact, rinse the affected area immediately with water.
• A clinical diagnosis cannot be determined from the test alone. This will be determined by a doctor based on clinical and laboratory results.
• After use, dispose of the test as ordinary municipal waste in accordance with applicable legislation.

Sample preparation and procedure
Collect stool samples onto toilet paper or into a suitable container - these are not included with the test. The diluted stool in the extraction tube must be processed within 30 minutes.
Do not collect samples during menstruation, severe diarrhoea, or bleeding haemorrhoids.

1. Open the coloured cap of the tube and dip the tip of the probe (the entire thread) into the stool sample at various points, no more than the thread can hold.
2. Insert the probe into the tube, screw it on tightly and shake.

3. Remove the test cassette from the aluminium foil.
4. Release the tip on the cap of the closed tube and squeeze 3 drops into window S on the cassette.

5. After 15 minutes, one or two lines will appear on the cassette. Do not read the results after 20 minutes.

Evaluation
1. Positive result - the sample is positive for Helicobacter pylori:

Two pink lines appear on the cassette. The coloured lines in the positive reaction zone T and the control zone C may differ in colour intensity, but this does not affect the interpretation of the result.

2. Negative result:

One pink line forms in the control zone C on the cassette. The reaction zone T remains without a line. The sample is negative for the presence of H. pylori.

3. If no line appears on the cassette, add a few more drops of extract into the window marked with an arrow or the letter S. If it still does not appear, repeat the test with a new cassette.

Complete information can be found in the package leaflet - instructions for use.

If you have any questions about the test, we will be happy to answer them.