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IVD H.pylori Rapid Test Kits
One-Step H.Pylori Test Devices
H. pylori rapid tests, also known as one-step H.Pylori tests, are a rapid medical testing device for the qualitative detection of antibodies of all isotypes (IgG, IgM, IgA, etc) specific to Helicobacter pylori in human serum, plasma or whole blood specimen. This test is performed out side of the body of the testee, so the test kit is also called IVD H.Pylori Test. Rapid H. pyloritest kits are intended to be used as an aid in the diagnosis of H. pylori infection in patients with gastrointestinal symptoms.
H.Pylori Immunoassay testing device is based on the double antigens sandwich immunoassay principle. When testing with a helicobacter pylori test cassette, H.pylori antigen–colloid gold conjugate and serum sample move along the membrane chromatographically to the test line region (T), where H.pylori capturing antigen is pre-coated. If antibodies to H.Pylori exist in the specimen, "antigen-antibody-antigen" gold particle complex will form, a pink color band will appear on the test region. If the inside quality control line (C) also emerge, then the two pink lines give a positive result. And on the contrary, if there is no antibody to the H.Pylori bacterium in the serum specimen, the "antigen-antibody-antigen" gold particle complex will not form at the test region, indicating a negative result.
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