H.Pylori Antigen Rapid Test Dipstick Lateral Flow Immunochromatographic Assays

A rapid test for the qualitative detection of circulating plasmodium falciparum (P.f.) in whole blood CE certified

Applications:

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 to aid in the diagnosis of H.pylori infection.

Description:

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.^1,2 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.⁴ 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.⁵

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.

How to 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.

• 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.
• 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.
• Read results at 5 minutes. Do not read results after 10 minutes.

INTERPRETATION OF RESULTS

(Please refer to the illustration above)

POSITIVE:*Two lines appear. One colored line should be in the control line region (C) and another apparent colored line should be in the test line region (T).

*NOTE: The intensity of the color in the test line region (T) will vary depending on the concentration of H.pylori antigen present in the specimen. Therefore, any shade of color in the test line region (T) should be considered positive.

NEGATIVE:One colored 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. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

QUALITY CONTROL

Internal procedural controls are included in the test. A colored line appearing in the control region (C) is an internal valid procedural control. It confirms sufficient specimen volume and correct procedural technique.

Control standards are not supplied with this kit; however, it is recommended that positive and negative controls be tested as a good laboratory practice to confirm the test procedure and to verify proper test performance.