H.pylori Antibody Lateral Flow Immunochromatographic Assays Strips , Whole Blood / Serum / Plasma

A rapid test for the qualitative detection of antibodies to Helicobacter pylori(H.pylori) in whole blood,serum or plasma CE certified

Applications:

The H. pylori Antibody Rapid Test Dipstick (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of antibodies to H. pylori in whole blood, serum, or plasma 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 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.^6,7,8 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.

How to use?

Allow the test, specimen, buffer and/or controls to reach room temperature (15-30°C) prior to testing.

• Bring the pouch to room temperature before opening it. Remove the test dipstick from the sealed pouch and use it as soon as possible.
• Place the dipstick on a clean and level surface.

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 75mL of fingerstick whole blood specimen to the specimen area of test dipstick, then add 1 drop of buffer (approximately 40 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 mL) and start the timer. See illustration below.

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

INTERPRETATION OF RESULTS

(Please refer to the illustration above)

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

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

NEGATIVE: One colored line appears in the control region (C). No apparent colored line appears in the test 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 dipstick. If the problem persists, discontinue using the test kit immediately and contact your local distributor.