For in vitro diagnostic use. Others CINtec PLUS Cytology US IVD Cervical Carcinoma CINtec® PLUS Cytology Kit RTD000761 CE-IVD Mouse Rabbit p16INK4a E6H4™ mouse monoclonal antibody, Ki-67:274-11 AC3V1 rabbit monoclonal antibody 06889565001 CINtec PLUS CYTOLOGY CE-US EXPORT CINtec PLUS Cytology 04015630972807 Reagents, kits 605-100 100 tests Not Available true The CINtec PLUS Cytology Kit is an immunocytochemistry assay for the simultaneous qualitative detection of the p16INK4a and Ki-67 proteins in cervical cytology preparations. It is indicated to be used as an aid in the identification of women with high-grade cervical intraepithelial lesions in a screening population, and in the sub-groups of patients with a Pap cytology result of ASC-US (atypical squamous cells of undetermined significance) or LSIL (low-grade squamous intraepithelial lesion), or in patients with positive high-risk HPV test results.Interpretation of the test results may only be made by a certified professional in conjunction with the patient´s clinical history and additional diagnostic tests that have been performed.The product is intended for in vitro diagnostic (IVD) use.   en The CINtec PLUS Cytology Kit contains a set of reagents for the simultaneous immunocytochemical detection of the p16INK4a and Ki-67 proteins in cytological specimens obtained from the uterine cervix. The proteins are detected using a ready-to-use cocktail of primary monoclonal antibodies which contains a monoclonal mouse antibody directed against human p16INK4a protein (clone E6H4™) and a primary recombinant rabbit antibody directed against human Ki-67 protein (clone 274-11AC3V1). Following cell conditioning, inhibition of endogenous peroxidase activity and incubation with the primary antibody cocktail, the assay uses two ready-to-use detection systems optimized for use on cervical cytology specimens:A goat anti-mouse secondary antibody covalently attached to HQ haptens (proprietary hapten) and an anti-HQ hapten, horseradish peroxidase (HRP)-conjugated tertiary antibody optimized for the detection of the monoclonal mouse antibody clone E6H4;A goat anti-rabbit secondary antibody covalently attached to NP haptens (proprietary hapten) and an anti-NP hapten, alkaline-phosphatase (AP)-conjugated tertiary antibody optimized for the detection of the rabbit recombinant antibody clone 274-11AC3V1.The chromogenic reactions are based on the HRP-mediated conversion of 3,3’-diaminobenzidine tetrahydrochloride (DAB) and the AP-mediated conversion of Fast Red with Naphthol Phosphate resulting in a brown precipitate at the p16INK4a antigen site and a red precipitate at the Ki-67 antigen site, respectively.After automated counterstaining and bluing, a two-step mounting procedure is followed. First, the slide is mounted using an aqueous mounting medium. Subsequently, the slide is coverslipped using a permanent mounting medium. The staining results are evaluated by light microscopy inspection.    en