H. pylori Antibody Rapid Test Cassette（WB/S/P）

【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 .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 Non-invasive techniques include the urea breath test, which requires expensive laboratory equipment and moderate radiation exposure, and serological methods. 4,5 Individuals infected with H. pylori develop antibodies which correlate strongly with histologically confirmed H. pylori infection.

The H. pylori Antibody Rapid Test Cassette (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 cassette from the sealed pouch and use it as soon as possible.
2. Place the cassette on a clean and level surface.
For Serum or Plasma specimen:
· Hold the dropper vertically and transfer 3 drops of serum or plasma (approximately 75 ul) to the specimen well of test Cassette and start the timer. See illustration below.
For Venipuncture Whole Blood specimen:
· Hold the dropper vertically and transfer 3 drops of whole blood (approximately 75 ul) to the specimen well, then add 1 drop of buffer (approximately 40 mL), and start the timer. See illustration below.
For Fingerstick Whole Blood specimen:
· To use a capillary tube: Fill the capillary tube and transfer approximately 75 ul of fingerstick whole blood specimen to the specimen area of test cassette, 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 ul) to fall into the specimen area of test cassette, then add 1 drop of buffer (approximately 40 ul) 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.