H. pylori Antigen Rapid Test Dipstick(Feces)

【SUMMARY】
H.pylori is a small, spiral-shaped bacterium that lives in the surface of the stomach and duodenum. It is implicated in the etiology of a variety of gastrointestinal diseases, including duodenal and gastric ulcer, non-ulcer dyspepsia and active and chronic gastritis. Both invasive and non-invasive methods are used to diagnose H.pylori infection in patients with symptoms of gastrointestinal disease. Specimen-dependent and costly invasive diagnostic methods include gastric or duodenal biopsy followed by urease testing (presumptive), culture, and/or histologic staining. 3 A very common approach to the diagnosis of H.pylori infection is the serological identification of specific antibodies in infected patients. The main limitation of serology test is the inability to distinguish current and past infections. Antibody may be present in the patient’s serum long after eradication of the organisms. HpSA (H. pylori Stool Antigen) testing is gaining popularity for diagnosis of H. pylori infection and also for monitoring the efficacy of the treatment of H. pylori infection. Studies have found that more than 90% of patients with duodenal ulcer and 80% of patients with gastric ulcer are infected with H.pylori. The H.pylori Antigen Rapid Test Dipstick (Feces) is a rapid chromatographic immunoassay for the qualitative detection of H.pylori antigens in human feces specimens, providing results in 10 minutes. The test utilizes antibodies specific for H. pylori antigens to selectively detect H.pylori antigens in human feces specimens.

【DIRECTIONS FOR USE】
Allow the test, specimen, buffer and/or controls to reach room temperature (15-30°C) prior to testing.
1. To collect fecal specimens:
Collect sufficient quantity of feces (1-2 mL or 1-2 g) in a clean, dry specimen collection container to obtain maximum antigens (if present). Best results will be obtained if the assay is performed within 6 hours after collection. Specimen collected may be stored for 3 days at 2-8℃ if not tested within 6 hours. For long term storage, specimens should be kept below -20℃.
2. To process fecal specimens:
• For Solid Specimens:
Unscrew the cap of the specimen collection tube，then randomly stab the specimen collection applicator into the fecal specimen in at least 3 different sites to collect approximately 50 mg of feces (equivalent to 1/4 of a pea). Do not scoop the fecal specimen.
• For Liquid Specimens:
Hold the dropper vertically, aspirate fecal specimens, and then transfer 2 drops (approximately 80μL) into the specimen collection tube containing the extraction
buffer.
Tighten the cap onto the specimen collection tube, then shake the specimen collection tube vigorously to mix the specimen and the extraction buffer. Leave the tube alone for 2minnutes.
3. Bring the pouch to room temperature before opening it. Remove the test dipstick from the foil pouch and use it as soon as possible. Best results will be obtained if the
test is performed immediately after opening the foil pouch.
4. Fix the reaction tube, hold the specimen collection tube upright and break off the tip of the specimen collection tube. Invert the specimen collection tube and transfer 8-10 full drops of the extracted specimen (approx. 500μL) to the reaction tube, then with arrows pointing toward the exaction buffer, immerse the dipstick and start the timer. Do not immerse the dipstick past the maximum line. See illustration below.
5. Read results at 5 minutes. Do not read results after 10 minutes.