INTENDED USE

The H. Pylori Ab Rapid Test is a sandwich lateral flow chromatographic immunoassay for the qualitative detection of antibodies (IgG, IgM, and IgA) anti- Helicobacter pylori (H. Pylori) in human serum, plasma, whole blood. It is intended to be used as a screening test and as an aid in the diagnosis of infection with H. Pylori. Any reactive specimen with the H. Pylori Ab Rapid Test Kit must be confirmed with alternative testing method(s) and clinical findings.

SUMMARY

Helicobacter pylori is associated with a variety of gastrointestinal diseases included non-ulcer dyspepsia, duodenal and gastric ulcer and active, chronic gastritis. The prevalence of H. pylori infection could exceed 90% in patients with signs and symptoms of gastrointestinal diseases. Recent studies indicate an association of H. Pylori infection with stomach cancer.H. Pylori colonizing in the gastrointestinal system elicits specific antibody responses which aids in the diagnosis of H. Pylori infection and in monitoring the prognosis of the treatment of H. Pylori related diseases. Antibiotics in combination with bismuth compounds have been shown to be effective in treating active H. Pylori infection. Successful eradication of H. pylori is associated with clinical improvement in patients with gastrointestinal diseases providing a further evidence.
The H. Pylori Combo Ab Rapid Test is a latest generation of chromatographic immunoassay which utilizes recombinant antigens to detect the antibodies to H. Pylori in human serum or plasma. The test is user friendly, highly sensitive and specific.

PRINCIPLE

The H. Pylori Ab Rapid Test is a lateral flow chromatographic immunoassay based on the principle of the double antigen–sandwich technique. The test cassette consists of: 1) a burgundy colored conjugate pad containing H. Pylori antigens including Cag-A conjugated with colloid gold (H. Pylori conjugates) and rabbit IgG-gold conjugates, 2) a nitrocellulose membrane strip containing a test band (T band) and a control band (C band). The T band is pre-coated with non-conjugated H. Pylori antigens, and the C band is pre-coated with goat anti-rabbit IgG.

When an adequate volume of test specimen is dispensed into the sample well of the cassette, the specimen migrates by capillary action across the cassette. The antibodies: either the IgG, the IgM, or the IgA, to H. Pylori if present in the specimen will bind to the H. Pylori conjugates. The immunocomplex is then captured on the membrane by the pre-coated H. Pylori antigens, forming a burgundy colored T band, indicating a H. Pylori Ab positive test result.

Absence of the T band suggests a negative result. The test contains an internal control (C band) which should exhibit a burgundy colored band of the immunocomplex of goat anti-rabbit IgG/rabbit IgG-gold conjugate regardless the presence of any antibodies to H. Pylori. Otherwise, the test result is invalid and the specimen must be retested with another device.