The CINtec® Histology kit is an immunohistochemistry (IHC) assay for the qualitative detection of the p16 protein on slides prepared from formalin-fixed, paraffin-embedded cervical biopsies.
The over-expression of p16 in cervical biopsies is highly correlated to the oncogenic transformation caused by persistent HR-HPV infection which may lead to the development of high-grade cervical dysplasia (CIN 2/3), adenocarcinoma in situ (AIS), and invasive cervical carcinomas. The adjunctive use of p16 provides additional information after initial diagnosis has been made by established diagnostic methods. Using a two-step IHC protocol. p16 over-expression is visualized as a brown color precipitate.
CINtec® Histology Kit: Contents
The kit includes ready-to-use p16 antibody (clone E6H4™) and Negative Reagent Control, peroxidase-blocking reagent, epitope retrieval solution and visualization reagent and wash buffer.
CINtec® Histology Kit: Intended Use
The CINtec® Histology Kit is an immunohistochemistry assay for the qualitative detection of the p16INK4a protein on formalin-fixed, paraffin-embedded tissue sections prepared from cervical biopsies.
It is intended for use in medical pathology laboratories to provide adjunctive information after initial diagnosis has been made by established diagnostic methods. Interpretation of the test results may only be made by a certified professional in conjunction with the patient´s clinical history and any additional diagnostic tests that have been performed.
The CINtec® p16INK4a Histology kit is available on a global basis through mtm's direct operations and distributors and orders can be placed directly through this website.
The literature on using p16 in interpreting cervical biopsies is extensive. Click here to view a list of current research articles on the topic.
The CINtec® p16INK4a Histology kit is based on technology developed by Roche mtm laboratories AG, Germany and based on European Patent 1 092 155 and U.S. Patent 6,709,832; further patents pending.
CINtec® Histology Kit Insert
CINtec® Histology V-Kit Insert
CINtec® Histology Protocol Piece for manual use
CINtec® Histology Protocol Piece for automated use
CINtec® Histology Material Safety Data Sheet
CINtec® Wash Buffer Material Safety Data Sheet