Hp - quick test for helicobacter pylori

Product Description

In vitro diagnostic medical device CE 0123.

Indications

Rapid test for the qualitative detection of Helicobacter pylori (H. pylori) antigens in human feces.

For in vitro self-diagnostic use only.

Directions for use

1. Wash your hands with soap and rinse with clean water.
2. For fecal specimen collection: The fecal specimen must be collected on the stool collection sheet or in a clean container. Please use the stool collection sheet, avoiding contamination of the specimen by taking appropriate precautions so that the specimen or the side of the paper containing the specimen does not come into contact with other contaminating objects, including bathroom products.
3. To test stool samples: Unscrew the cap on the sample collection tube, then randomly insert the sample collected with the applicator into the stool sample in at least 3 different places. Do not shake the stool sample. Replace and secure the cap on the collection tube, then shake the sample collection tube vigorously to mix the sample and extraction buffer.
4. Allow the package to reach room temperature before opening. Remove the test device from the sealed package and use it as soon as possible. Best results are obtained if the test is performed immediately after opening the package.
5. Open the cap on the sample collection tube and break the tip. Invert the tube and dispense 2 full drops of the extracted sample into the sample well (S) on the test device, then start the timer. Avoid trapping air bubbles in the sample well (S).
6. Read the results after 10 minutes. Do not read results after 20 minutes.

Warnings

1. For in vitro self-diagnostic use only.
2. Do not eat, drink, or smoke in the area where the specimens or kits are handled.
3. Store in a dry place at 2-30°C (36-86°F), avoiding areas of excessive humidity. If the sealed pouch is damaged or opened, do not use the test.
4. Use a clean container to collect the stool specimen.
5. Carefully observe the indicated times.
6. Use the test only once.
7. Do not disassemble or touch the test window on the holder.
8. The kit should not be frozen or used beyond the expiration date printed on the pouch.
9. After use, all components should be disposed of with normal household waste.
10. Keep out of reach of children.

Limitations

1. The H. pylori Antigen Test (Feces) is for in vitro diagnostic use only. The test should be used only for the detection of H. pylori antigens in stool specimens. This qualitative test does not determine either the quantitative value or the rate of increase in H. pylori antigen concentration.
2. The H. pylori Antigen Test (Feces) will only indicate the presence of H. pylori in the specimen and should not be used as the sole criterion for establishing H. pylori as the causative agent of peptic or duodenal ulcers.
3. As with all diagnostic tests, all results should be interpreted in conjunction with other clinical information available to the physician.
4. If the test result is negative and clinical symptoms persist, further testing using other clinical methods is recommended. A negative result in no way excludes the possibility of an H. pylori infection.
5. With some antibiotic treatments, the concentration of H. pylori antigens may drop below the minimum detectable level of the test. Therefore, diagnosis during antibiotic treatment should be made with caution.

Storage

The kit can be stored at room temperature or refrigerated (2-30°C).
The test is stable until the expiration date printed on the sealed package.
The test must remain in the sealed package until use.
DO NOT FREEZE. Do not use beyond the expiration date.

Format

Pack containing 1 piece.