Human Stool Helibacter Pylori Antigen Rapid Test

In vitro diagnostic medical device CE 0123.
Rapid test for l Qualitative detection of Helicobacter pylori (H. pylori) antigens in human feces.
For in vitro self-diagnostic use only.

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

How to use
1. Wash your hands with soap and rinse with clean water.
2. For the collection of stool samples: the stool sample must be collected in the stool collection sheet or in a clean container. Please use the stool collection sheet, avoiding contamination of the sample by taking precautions so that the sample or the side of the paper containing the sample does not come into contact with other contaminating objects including bathroom products.
3. To analyze fecal samples: unscrew the cap of the sample collection tube, then randomly stick the collected sample with the applicator into the fecal sample in at least 3 different places. Do not shake the stool sample. Retighten and secure the cap onto the collection tube, then shake the sample collection tube vigorously to mix the sample and extraction buffer.
4. Bring the package to room temperature before opening it. Remove the test device from the sealed package and use it as soon as possible. Better results are obtained if the test is performed immediately after opening the package.
5. Open the cap on the sample collection tube and break off the tip. Invert the tube and pour 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 at 10 minutes. Do not read results after 20 minutes.

Reading results
POSITIVE*: Two lines appear. Both the T (Test) and C (Control) lines appear. This result indicates the presence of H. pylori antigen in the stool and you should consult a doctor.
NEGATIVE: A colored line appears in the control zone (C). No line appears in the test area (T). This result indicates that the presence of H. pylori antigen could not be detected in the stool.
NULL: the control line does not appear. The most likely reasons for control line failure are insufficient sample volume or incorrect procedural techniques. Review the procedure and repeat the test with a new kit. If the problem persists, discontinue use of the kit immediately and contact your local distributor.
*The color intensity in the test region (T) varies depending on the concentration of H. pylori antigen present in the specimen. Therefore, any gradation of color of the test line (T) is to be considered positive.

Limitations
1. The H. pylori antigen test (Stool) 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 allow determining either the quantitative value or the growth rate of the H. pylori antigen concentration.
2. The H. pylori antigen test (Stool) will only indicate the presence of H. pylori in the specimen and should not be used as the sole criterion to establish that H. pylori is the causative agent of peptic or duodenal ulcers.
3. As with all diagnostic tests, all results must 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 H. pylori infection.
5. Following some antibiotic treatments, the concentration of H. pylori antigens can drop below the minimum detection 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 used.
DO NOT FREEZE. Do not use beyond the expiry date.

Format
Pack containing 1 piece.