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MEDICAL ASSISTANCE HELICOBACTER PYLORI TEST Description A rapid immunochromatographic assay for the qualitative detection of Helicobacter pylori antigens in human stool specimens. It uses antibodies specific for H. pylori antigens to selectively detect H. pylori antigens in human stool specimens. In this test, the membrane is pre-coated with anti-H. pylori antibody 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 antibodies 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. 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 that membrane filtration 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 part 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 of 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 specimen into the sample well (S) of the test cassette, then start the timer. Avoid trapping air bubbles in the sample well (S). Read results after 10 minutes. Do not read results after 20 minutes. Interpretation of 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: Control line (C) does not appear. 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 strip. If the problem persists, immediately discontinue use of the test kit 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 being handled. If the foil packaging is damaged or has been opened, do not use it. Use a clean container to collect the stool sample. Strictly adhere to 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 only be used for the detection of H. pylori antigens in stool samples. 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 sample and should not be used as the sole diagnostic criterion to determine whether Helicobacter pylori is a causative agent of peptic or duodenal ulcers. Test results must 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 excludes the possibility of H. pylori infection. Following antibiotic treatment, the concentration of H. pylori antigens may decrease to a concentration below the minimum detection level of the test. Therefore, the diagnosis should be made with caution during antibiotic treatment. Conservation Store at room temperature or in a refrigerator (2-30°C), avoiding areas with excessive humidity. Do not freeze. The test is stable until the expiration date printed on the sealed package. The test cassette should remain in the sealed pouch until use. Do not use after the expiration date. Shelf life in intact packaging: 24 months. Format The kit contains: - test cassette; - sample collection tube with extraction buffer; - the prospectus; - paper for collecting feces. Bibliography 1. Marshall, BJ, McGechie, DB, Rogers, PAR and Glancy, RG Campylobacter pylori 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: urease detection as a marker of bacterial colonization and gastritis. Amer. J. Gastroenterology. (1987), 82(4): 292-296. 4. Cutler AF. Helicobacter pylori testing in clinical practice. Am J. Med. 1996;100:35S-41S. 5. Anand BS, Raed AK, Malaty HM et al. Prevalence of peptic ulcer in normal subjects with Helicobacter pylori infection. Am J Gastroenterol. 1996,91: 1112-1115. Code MM-IHP-602H
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