Description
A rapid chromatographic immunoassay for the qualitative detection of Helicobacter pylori antigens in human stool samples. It uses antibodies specific for H. pylori antigens to selectively detect H. pylori antigens in human stool samples.
In this test, the membrane is precoated with anti-H. pylori on the test line region. During the test, the sample reacts with the anti-H. pylori antibody-coated particle. The mixture migrates up the membrane by capillary action to react with the anti-H. pylori on the membrane, generating a colored line.
The presence of this colored line in the test region indicates a positive result, while its absence indicates a negative result. To serve as a procedural control, a colored line will always appear in the control line region, indicating that an adequate volume of specimen has been added and membrane wicking has occurred.

How to use
Wash your hands with soap and rinse with water.
The stool sample should be collected on stool collection paper or in clean collection containers. Use stool collection paper, avoiding contamination of the sample by taking precautions to ensure that the sample or the side of the paper containing the sample does not come into contact with contaminants, including toilet cleaners.
Unscrew the cap of the sample collection tube, then randomly insert the sample collection applicator into the stool sample in at least 3 different locations. Do not collect the stool sample. Screw and tighten the cap on the sample collection tube, then shake the sample collection tube vigorously to mix the sample and extraction buffer for 2 minutes.
Bring the pouch to room temperature before opening. Remove the test cassette from the foil pouch and use it as soon as possible. Best results are obtained if the test is performed immediately after opening the foil pouch.
Open the cap of the sample collection tube and break off the tip. Invert the sample collection tube and transfer two full drops of the extracted sample into the sample well (S) of the test cassette, then start the timer. Avoid trapping air bubbles in the sample well (S).
Read the results after 10 minutes. Do not read the results after 20 minutes.

Interpretation of the results
POSITIVE: Two lines appear, the test line (T) and the control line (C). The intensity of the color in the test line (T) region will vary depending on the concentration of Helicobacter pylori antigen present in the sample. Therefore, any shade of color in the test line (T) region should be considered positive. This result means that H. pylori antigen is present in the stool and you should consult a doctor.

NEGATIVE: A colored line appears in the control line region (C). No line appears in the test line region (T). This result means that H. pylori is not detectable in the stool.

INVALID: The control line (C) does not appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for the control line (C) not appearing. Review the procedure and repeat the test with a new test. If the problem persists, discontinue use of the test kit immediately and contact your local distributor.

Warnings
For in vitro diagnostic self-testing only. Do not use after the expiration date.
Do not eat, drink, or smoke in the area where specimens or kits are handled.
If the foil package is damaged or has been opened, do not use it.
Use a clean container to collect the fecal sample.
Strictly follow the indicated times.
Use the test only once. Do not disassemble or touch the test window of the test cassette.
Dispose of the used test according to local regulations.
Keep out of reach of children.
The test should be used to detect H. pylori antigens in stool samples only. Neither the quantitative value nor the rate of increase in H. pylori antigen concentration can be determined with this qualitative test.
The test will only indicate the presence of Helicobacter pylori in the specimen and should not be used as the sole diagnostic criterion to determine whether Helicobacter pylori is a causative agent for peptic or duodenal ulcer.
Test results should be interpreted in conjunction with other clinical information available to the physician.
If the test result is negative and clinical symptoms persist, further testing using other clinical methods is recommended. A negative result never precludes the possibility of H. pylori infection.
Following some antibiotic treatments, the concentration of H. pylori antigens may decrease to a concentration below the minimum detection level of the test. Therefore, diagnosis should be made with caution during antibiotic treatment.

Conservation
Store at room temperature or refrigerated (2-30°C), avoiding areas of excessive humidity. Do not freeze.
The test is stable until the expiration date printed on the sealed package. The test cassette must remain in the sealed pouch until use. Do not use beyond the expiration date.
Shelf life in intact packaging: 24 months.

Format
The kit contains:
- test cassette;
- sample collection tube with extraction swab;
- package leaflet;
- paper for collecting feces.

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: 439-444.
2. Soll, AH. Pathogenesis of peptic ulcer disease and implications for therapy. New England J. Med. (1990), 322: 909-916.
3. Hazell, S. L., et al. Campylobacter pylori and gastritis I: detection of urease as a marker of bacterial colonization and gastritis. Amer. J. Gastroenterology. (1987), 82 (4): 292-296.
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. Prevalence of peptic ulcer disease in normal subjects with Helicobacter pylori infection. Am J Gastroenterol. 1996,91: 1112-1115.

Cod. MM-IHP-602H