Helicobacter Pylori Antigen Rapid Test Cassette

A rapid test for the qualitative detection of Helicobacter pylori (H pylori) antigens in human faeces.

The H pylori Antigen Rapid Test Cassette (Faeces) is a rapid chromatographic immunoassay. It is for the qualitative detection of H pylori antigens in human faeces specimens to aid in the diagnosis of H. pylori infection.

For professional use only

To collect faecal specimens

Collect sufficient quantity of faeces (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°C if not tested within 6 hours. For long term storage, specimens should be kept below -20°C.

To process faecal specimens

For Solid Specimens: Unscrew the cap of the specimen collection tube, then randomly stab the specimen collection applicator into the faecal specimen in at least 3 different sites to collect approximately 50 mg of faeces (equivalent to 1/4 of a pea). Do not scoop the faecal specimen. For Liquid Specimens: Hold the dropper or pipette vertically, aspirate faecal specimens, and then transfer 2 drops (approximately 80 μL) 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.

To test a sample

Bring the pouch to room temperature before opening it. Remove the test cassette from the foil pouch and use it within one hour. Best results will be obtained if the test is performed immediately after opening the foil pouch. Hold the specimen collection tube upright and open the cap onto the specimen collection tube. Invert the specimen collection tube and transfer 2 full drops of the extracted specimen (approximately 80 μL) to the specimen well of the test cassette, then start the timer. Avoid trapping air bubbles in the specimen well. Read results

Interpretation of results

POSITIVE:* Two lines appear. One red line should be in the control line region (C) and another apparent red line should be in the test line region (T). *NOTE: The intensity of the colour in the test line region (T) will vary depending on the concentration of H.pylori antigen present in the specimen. Therefore, any shade of colour in the test line region (T) should be considered positive. NEGATIVE: One red line appears in the control line region (C). No line appears in the test line region (T). INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test.

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