For in vitro diagnostic use. Others CINtec PLUS Cytology Kit Ca Jp IVD Cervical Carcinoma CINtec® PLUS Cytology Kit RTD000760 Canada / Japan Mouse Rabbit E6H4™, 274-11 AC3 06 889 549 001 6 889 549 001 06889549001 6889549001 06889549001 CINtec PLUS CYTOLOGY-US EXPORT CINtec PLUS Cytology Kit 04015630976287 Reagents, kits 805-100 100 tests Not Available true 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-touse 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 274-11 AC3). 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 274-11 AC3. 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 For in vitro diagnostic (IVD) use. CINtec® PLUS Cytology Kit is an immunocytochemistry assay for the simultaneous qualitative detection of the p16INK4a and Ki-67 proteins in cervical cytology preparations. 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. en

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