Description
Rapid chromatographic immunoassay for the qualitative detection of Helicobacter pylori antigens in human stool samples. It uses specific antibodies for H. pylori antigens to selectively detect H. pylori antigens in human stool samples.
In this test, the membrane is pre-coated with anti-H. pylori on the test line region. During testing, the sample reacts with the anti-H. pylori antibody-coated particle. The mixture migrates upward on the membrane by capillary action to react with the anti-H. pylori on the membrane and generate a colored line.
The presence of this colored line in the test area 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 sample has been added and membrane wicking has occurred.

Instructions for use
Wash 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 so that the sample or the side of the paper containing the sample does not come into contact with contaminating objects, including toilet cleaners.
Unscrew the cap of the sample collection tube, then randomly stab the sample collection applicator into the fecal sample in at least 3 different sites. Do not scoop the fecal sample. Screw and tighten the cap onto the sample collection tube, then vigorously shake the sample collection tube 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 the tip. Invert the sample collection tube and transfer 2 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 at 10 minutes. Do not read the results after 20 minutes.

Interpretation of results
POSITIVE: Two lines are displayed, the test line (T) and the control line (C). The color intensity in the test line region (T) will vary depending on the concentration of Helicobacter pylori antigen present in the sample. Therefore, any shade of color in the test line zone (T) 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 area (C). No line appears in the test line area (T). This result means that the presence of H. pylori in the stool is not detectable.

INVALID: The control line (C) is not displayed. Insufficient sample 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, stop using 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 samples or kits are handled.
If the aluminum packaging 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 for the detection of H. pylori antigens only in stool samples. Neither the quantitative value nor the rate of increase in the concentration of H. pylori antigens can be determined by this qualitative test.
The test will only indicate the presence of Helicobacter pylori in the sample and should not be used as the sole diagnostic criterion to determine if Helicobacter pylori is an etiological agent for peptic or duodenal ulcers.
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.

Storage
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 packaging. The test cassette must remain in the sealed pouch until use. Do not use beyond the expiration date.
Shelf life unopened: 24 months.

Format
The kit contains:
- test cassette;
- sample collection tube with extraction buffer;
- leaflet;
- stool collection paper.

Bibliography
1. Marshall, BJ, McGechie, DB, Rogers, PAR, and Glancy, RG. Campylobacter pyloric infection and gastroduodenal disease. Med. J. Australia. (1985), 149: 439-444.
2. Soll, AH. Pathogenesis of peptic ulcer and implications for therapy. New England J. Med. (1990), 322: 909-916.
3. Hazell, SL, 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. Tests for Helicobacter pylori in clinical practice. Am J Med. 1996; 100: 35S-41S.
5. Anand BS, Raed AK, Malaty HM, et al. Prevalence of Loe point of peptic ulcer in normal subjects with Helicobacter pylori infection. Am J Gastroenterol. 1996,91: 1112-1115.

Code MM-IHP-602H