For in vitro diagnostic use. Others CINtec PLUS Kit IVD Cervical Carcinoma CINtec® PLUS Kit RTD001246 CE-IVD Mouse Rabbit p16: E6H4™ mouse monoclonal antibody, Ki-67: 274-11 AC3 rabbit monoclonal antibody 9531 CINtec PLUS Cytology Kit 04015630983889 50 tests false CINtec PLUS Cytology Kit (CE/IVD) 06595367001 Not Available Reagents, kits en For in vitro diagnostic use.The CINtec® PLUS Kit is an immunocytochemistry assay for the simultaneous qualitative detection of the p16INK4a and Ki-67 proteins in cervical cytology preparations.It is intended 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.The kit is intended to be used in medical cytology laboratories. 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 test is intended for manual use, or for use on Autostainer instruments. en The CINtec® PLUS Kit contains a set of reagents for the immunocytochemical detection of the p16INK4a and Ki-67 antigens. The kit is designed to perform a two-step immunocytochemical staining procedure for cytological specimens obtained from the cervix uteri. For the detection of the antigens, a primary monoclonal mouse an-tibody clone E6H4™ directed to human p16INK4a protein and a primary monoclonal rabbit antibody clone 274-11 AC3 directed against human Ki-67 protein are used.Ready-to-use visualization reagents comprising (i) a polymer reagent conjugated to horseradish peroxidase and goat anti-mouse Fab’ antibody fragments, and (ii) a polymer reagent conjugated to alkaline phosphatase and goat anti-rabbit Fab’ antibody fragments are used. The visualization reagents have been subjected to solid-phase absorption to eliminate cross reactivity with human immunoglobulins.The chromogen reactions are based on horseradish peroxidase-mediated conver-sion of a DAB chromogen, and alkaline phosphatase-mediated conversion of Fast Red chromogen to visible reaction products at the respective antigen sites. After counterstaining, a two step mounting protocol must be applied: in a first step, an aqueous mounting of the specimens using an aqueous mounting medium provided with the kit must be used. Subsequently, the slides may be cover-slipped using e.g. a permanent mounting medium. The results can be evaluated by light microscopy inspection.