One Step Helicobacter Pylori Stool Antigen(HPSA) R

INTRODUCTION JD's One Step Helicobacter Pylori Stool Antigen (HP Ag) Rapid Test Kit (Strip/Card) is a rapid, non invasive, easy to perform test that can be used to detect active infection, monitor effectiveness during therapy and to confirm cure after antibiotic use. The ease to collect the specimen, especially in children, in whom endoscopy would be difficult and the non requirement of specially trained staff to collect and perform the test adds to the tests advantage. Also, prior preparation of the patient is not necessary unlike in upper gastrointestinal endoscopy. PRINCIPLE OF THE TEST This assay is a double antibodies chromatographic lateral flow immunoassay. The test strip in the device includes: 1) a burgundy-colored conjugate pad containing colloidal gold coupled with H. pylori ( out of membrane protein, OMP) polyclonal antibodies, and 2) nitrocellulose membrane containing a test line ( T - line) and a control line (C- line). The T line is coated with H. pylori antibody, 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 patient antigen to H. pylori are present in the specimen, the T line will become a burgundy-colored band . If antigen 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 antigen 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.