Description
In vitro diagnostic medical device CE 0123.
Rapid test for the 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 between 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 fecal sample.
5. Observe the indicated times carefully.
6. Use the test only once.
7. Do not disassemble or touch the test window on the stand.
8. The kit must not be frozen or used beyond the expiration date printed on the package.
9. After use, all components must 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 fecal sample collection: The fecal sample must be collected on the stool collection sheet or in a clean container. Please use the stool collection sheet, avoiding contamination of the sample by taking appropriate precautions to ensure that the sample or the side of the paper containing the sample does not come into contact with other contaminants, including bathroom products.
3. To analyze stool samples: Unscrew the cap of 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 off the tip. Invert the tube and place 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 the results after 20 minutes.

Reading the 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 region (C). No line appears in the test region (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 the control line not appearing are insufficient specimen volume or improper 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 intensity of the color in the test region (T) varies depending on the concentration of H. pylori antigen present in the specimen. Therefore, any shade of color on the test line (T) is considered positive.

Limits
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 samples. This qualitative test does not allow the quantitative value or rate of increase in H. pylori antigen concentration to be determined.
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 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.

Conservation
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 pouch until ready for use.
DO NOT FREEZE. Do not use after the expiration date.

Format
Package containing 1 piece.

BIBLIOGRAPHY:
1. Marshall, B.J., McGechie, D.B., Rogers, P.A.R. and Glancy, R.G. Pyloric Campylobacter infection and gastroduodenal disease. Med. J. Australia. (1985), 149: 439-44.
2. Soll, A.H. Pathogenesis of peptic ulcer and implications for therapy. New England J. Med. (1990), 322: 909-16.
3. Hazell, S. L., et al. Campylobacter pylori is and gastritis I: Detection of urease as a marker of bacterial colonization and gastritis. Amer. J. Gastroenterology. (1987), 82(4): 292-96.
4. Cutler AF. Testing for Helicobacter pylori in clinical practice. Am j. Med. 1996; 100:35S-41S.
5. Anand BS, Raed AK, Malaty HM, et al. Loe point prevalence of peptic ulcer in normal individual with Helicobacter pylori infection. Am J Gastroenterol. 1996,91:1112-1115.