For in vitro diagnostic use. Others CINtec Histology Kit CE IVD IVD Normal Pancreas Normal Tonsil Cervical Carcinoma CIN2+ CINtec® Histology Kit RTD000759 CE-IVD Mouse E6H4™ 10213370001 CINtec Histology Kit (CE/IVD) CINtec Histology Kit 07613336230350 Reagents, kits Not Available Not Available For in-vitro diagnostic use.The CINtec® Histology Kit is an immunohistochemistry assay for the qualitative detection of the p16INK4a antigen on tissue sections prepared from formalin-fixed, paraffin-embedded cervical biopsies.It is indicated to be used in conjunction with H&E-stained slides prepared from the same cervical tissue specimen as an aid to increase diagnostic accuracy and inter- observer agreement in the diagnosis of high-grade cervical intraepithelial neoplasia.The test is intended for manual use, or for use on Autostainer instruments.This assay should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information, and proper controls. en The CINtec® Histology Kit contains a set of reagents for the immunohistochemical detection of the p16INK4a antigen. The Kit is designed to perform a two-step immunohistochemical staining procedure for formalin-fixed, paraffin-embedded tissue specimens obtained from cervical biopsies. For the detection of the antigen, a primary monoclonal mouse antibody clone E6H4® directed to human p16INK4a protein is used.A ready-to-use visualization reagent comprising a polymer reagent conjugated with horseradish peroxidase and goat anti-mouse Fab’ antibody fragments is used. The Visualization Reagent has been subjected to solid-phase absorption to eliminate cross reactivity with human immunoglobulins. The chromogen reaction is based on horseradish peroxidase-mediated conversion of a DAB chromogen to a visible reaction product at the antigen site. After counterstaining, the specimen may be cover-slipped and the results may be evaluated by light microscopy inspection. en