H. Pylori IgG Rapid Test is intended to detect the presence of IgG antibodies specific to Helicobacter pylori (H. pylori) in h

    INTRODUCTION

    The H. Pylori IgG 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 or plasma. It provides an aid in the diagnosis of infection by H. pylori. This test has been evaluated for use with serum/plasma specimens of adults, 19 years and older.

    PRINCIPLE OF THE TEST

    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.