Intended Use This antibody is intended for in vitro diagnostic (IVD) use. Helicobacter pylori antibody is intended for qualified laboratories to qualitatively identify by light microscopy the presence of associated antigens in sections of formalin-fixed, paraffinembedded tissue sections using IHC test methods on the ImPath Autostainer. Use of this antibody is indicated, subsequent to clinical differential diagnosis, as an aid in the identification of helicobacter pylori bacteria in human tissue specimens within the context of an antibody panel, the patient’s clinical history, and other diagnostic tests evaluated by a qualified pathologist.
Summary And Explanation Anti-H. pylori antibody reacts with H. pylori typically found on the surface of pyloric and stomach mucosa. Studies have shown that H. pylori plays an important role in the etiology of chronic gastritis and the development of peptic ulcer disease.
Principles And Procedures The stated primary antibody may be used as the primary antibody for immunohistochemical staining of formalinfixed, paraffin-embedded tissue sections.
In general, immunohistochemical staining in conjunction with a streptavidin-biotin detection system allows the visualization of antigens via the sequential application of a specific antibody (primary antibody) to the antigen, a secondary antibody (link antibody) to the primary antibody, an enzyme complex and a chromogenic substrate with interposed washing steps. Alternatively, a biotin-free polymer detection system may be used. The enzymatic activation of the chromogen results in a visible reaction product at the antigen site. The specimen may then be counterstained and a coverslip applied. Results are interpreted using a light microscope and aid in the differential diagnosis of pathophysiological processes, which may or may not be associated with a particular antigen. Prediluted products are optimally diluted for use with a wide variety of detection kits offered by other manufacturers.
Materials And Methods See product label for lot specific information for the following: 1.
Antibody immunoglobulin concentration
2. Source details
Reagents Provided Prediluted The stated primary antibody product contains ready-to-use reagent in a vial made for use with the Menarini ImPath Autostainer. The vial is equipped with an RFID tag that is read by the autostainer to provide product and lot specific information. The predilute immunoglobulin concentration range for this product is 0.75-2.5 µg/ml. This antibody is diluted in Tris Buffer, pH 7.37.7, with 1% BSA and
