【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. Non-invasive techniques include the urea breath test, which requires expensive laboratory equipment and moderate radiation exposure, and serological methods. Individuals infected with H. pylori develop antibodies which correlate strongly with histologically confirmed H. pylori infection.

The H. pylori Antibody Rapid Test Dipstick (Whole Blood/Serum/Plasma) is a simple test that utilizes a combination of H. Pylori antigen coated particles and anti-human IgG to qualitatively and selectively detect H. pylori antibodies in whole blood, serum, or plasma.

【DIRECTIONS FOR USE】
Allow the test, specimen, buffer and/or controls to reach room temperature (15-30°C) prior to testing.
1. Bring the pouch to room temperature before opening it. Remove the test dipstick from the sealed pouch and use it as soon as possible.
2. Place the test cards on a clean and level desk, then peel off the strip label of the test cards, stick the test dipstick onto it as soon as possible before testing.
For Serum or Plasma specimen:
· Hold the dropper vertically and transfer 3 drops of serum or plasma (approximately 75mL) to the specimen area of test dipstick and start the timer. See illustration below.
For Venipuncture Whole Blood specimen:
· Hold the dropper vertically and transfer 3 drops of whole blood (approximately 75mL) to the specimen area, then add 1 drop of buffer (approximately 40mL), and start the timer. See illustration below.
For Fingerstick Whole Blood specimen:
· To use a capillary tube: Fill the capillary tube and transfer approximately 75m mL of fingerstick whole blood specimen to the specimen area of test dipstick, then add 1 drop of buffer (approximately 40 m mL) and start the timer. See illustration below.
· To use hanging drops: Allow 3 hanging drops of fingerstick whole blood specimen (approximately 75 mL) to fall into the specimen area of test dipstick, then add 1 drop of buffer (approximately 40 m mL) and start the timer. See illustration below.

3. Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 20 minutes.

 

Cat. No.	Product Description	Specimen	Format	Kit Size	Cut-Off	Status
IHP-401	H. pylori Antibody Rapid Test Dipstick	WB/S/P	Dipstick	50T	See Insert	CE