Helicobacter Pylori IgG Rapid Test

The H. pylori Rapid Test is a rapid lateral flow, qualitative immunoassay. It is intended for use at point of care facilities to detect the presence of IgG antibodies specific to Helicobacter pylori (H. pylori) in human serum. It provides an aid in the diagnosis of infection by H. pylori. This test has been evaluated for use with serum specimens of adults, 19 years and older.

Helicobacter pylori has been associated with a variety of gastrointestinal diseases including gastritis, duodenal and gastric ulcer, non-ulcer dyspepsia, gastric adenocarcinoma and lymphoma.  The exact role that H. pylori plays in gastrointestinal disease still needs to be precisely defined. However, the prevalence rates for H. pylori infection as demonstrated by histological and bacteriological methods can approach 90% in patients who present clinical symptoms of the gastrointestinal diseases listed above. H. pylori does not appear to invade the bloodstream since no isolates yet have been detected using commercial blood culture methods. H. pylori infections occur in human populations throughout the world. In developed countries, about 50% of the population may have H. pylori infection by the age of 60 years, while only 10-20% of adults in the third decade have it.
In patients who present clinical symptoms relating to the gastrointestinal tract there are two major methods of investigation: invasive and noninvasive. 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 discomfort and risk to the patient. Noninvasive techniques include urea breath tests and serological methods. Urea breath test requires the use of a small amount of radioactivity and a mass spectrometer. Serologic tests are employed to detect antibodies as human immune response to H. pylori.
This device detects IgG antibodies specific to H. pylori infection in patient's sera and plasma. It is a noninvasive method and does not use radioactive isotopes; the assay procedures are easy and do not require professional training; it provides a rapid result. It is a useful on-site aid in the diagnosis of H. pylori infection.

This assay is a double antigen chromatographic lateral flow immunoassay. The test strip in the device includes: 1) a burgundy-colored conjugate pad containing colloidal gold coupled with H. pylori antigens, and 2) nitrocellulose membrane containing a test line (T line) and a control line (C line). The T line is coated with H. pylori antigens, and the C line is coated with goat anti-H. pylori antibody. The antigens used in this device are from H. pylori cell lysate.When IgG antibodies specific to H. pylori are present in the specimen, the T line
will become a burgundy-colored band. If antibodies to H. pylori are not present or are present below the detectable level, no T line will develop. The C line should always appear as a burgundy-colored band regardless of the presence of antibodies to H. pylori. The C line serves as an internal qualitative control of the test system to indicate that an adequate volume of specimen has been applied and the flow occurred.