Accu Test H.Pylori Antibody Card Test

Accu Test H.Pylori Antibody Card Test is implicated in the aetiology of various gastrointestinal problems, including duodenal and gastric ulcers, non-ulcer dyspepsia and active and chronic gastritis. H.pylori infection is found in more than 90% of duodenal ulcer patients and around 75% of all peptic ulcer sufferers. H.pylori infection is also more common in gastric cancer patients. The risk of gastric cancer has been estimated to be six-fold higher in H.pylori-infected populations than in uninfected populations. H.pylori infections occur in human populations throughout the world. In developed countries, about 50% of the population may have H.pylori infection by 60 years, while only 10-20% of adults in the third decade of life have it. Transmission is by the faecal-oral or oral-oral route. Both invasive and non-invasive methods are used to diagnose H.pylori infection in patients with symptoms of gastrointestinal disease. Invasive methods include culture of gastric biopsy samples, histologic examination of stained biopsy specimens, or direct detection of the urease activity in the biopsy (CLO test). These methods need to obtain a biopsy sample by endoscopy, which is expensive, and usually results in discomfort and risk to the individuals. Noninvasive techniques include urea breath tests and serological methods. Urea breath test requires expensive laboratory equipment and moderate radiation exposure. Serologic tests are employed to detect antibodies as a human immune response to H.pylori, for example, the ELISA and the Western immunoblot.

Uses:

• The H.pylori Antibody Rapid Test Card is a lateral flow chromatographic immunoassay for the qualitative detection of antibodies to H.pylori in human whole blood/serum/plasma

• It provides aid in the diagnosis of infection with H.pylori

Product Specifications and Features:

• The H.pylori antibody rapid test card is an immunoassay based on the principle of the double antigen-sandwich technique

• During testing, a whole blood/serum/plasma specimen migrates upward by capillary action

• The antibodies to H.pylori, if present in the specimen will bind to the H.pylori conjugates

• The immune complex is then captured on the membrane by the pre-coated H.pylori antigens, and a visible pink-purple line will show up in the test line region, indicating a positive result

• If antibodies to H.pylori are not present or are present below the detectable level, a pink-purple line will not form in the test line region, indicating a negative result

• To serve as a procedural control, a pink-purple line will always appear at the control line region, indicating that the proper specimen volume has been added and membrane wicking has occurred

Indications:

• The H.pylori Antibody Rapid Test Card is limited to provide qualitative detection. The intensity of the test line does not necessarily correlate to the concentration of the antibody in the blood

• The results obtained from this test are intended to be an aid in diagnosis only

• Each physician must interpret the results in conjunction with the patient’s history, physical findings, and other diagnostic procedures

• A negative test result indicates that antibodies to H.pylori are either not present or at levels undetectable by the test

Directions For Use:

• Remove the test cassette from the sealed pouch and use it as soon as possible

• Place the test cassette on a clean and level surface

• For serum or plasma specimen: Hold the dropper vertically and transfer 3 drops of serum or plasma to the specimen well (S) of the test cassette, then start the timer

• For whole blood specimens: Hold the dropper vertically and transfer 1 drop of whole blood (approximately 30μl) to the specimen well(S) of the test cassette, then add 2 drops of buffer (approximately 70μl) and start the timer

• Read results in 15 minutes

• Do not interpret the result after 20 minutes

Safety Information:

• Store as packaged in the sealed pouch at 4-40℃

• The kit is stable within the expiration date printed on the label

• Once the pouch is open, the test should be used within one hour. Prolonged exposure to hot and humid environments will cause product deterioration

• Read the label carefully before use

• Keep out of reach of children