Intended Use:

Test for qualitative detection of Helicobacter pylori IgG/IgM antibodies in human serum and plasma.

Introduction:

Gastritis and peptic ulcers are one of the most common human diseases. Since the discovery of H. pylori, many reports have suggested that this organism is one of the main causes of ulcer diseases and stomach cancer. The eradication of H. pylori has been associated with elimination of ulcer diseases. The detection of the specific IgG antibodies to H. pylori has been shown to be an accurate method for detection of H. pylori infection in symptomatic patients.

Method Principal:

H. pylori IgG/IgM test device has 3 pre-coated lines on the surface of the membrane. The “Control Line” is used for procedural control. Control line should always appear if the test procedure is performed properly and the test reagents of control line are working. Anti-IgG and Anti-IgM antibodies coated on the test line 1 & 2 respectively. If sample contains antibody, reacts with gold conjugated nanoparticle and flow on the membrane. It will be captured by membrane coated antibodies depend on IgG or IgM type by developing purple colour on test line.