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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.
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CINtec PLUS Cytology is an innovative immunocytochemistry assay developed by Roche Diagnostics, designed to enhance cervical cancer screening through the dual detection of key biomarkers—p16INK4a and Ki-67. This advanced kit provides healthcare professionals with a reliable tool for identifying women at risk of high-grade cervical intraepithelial lesions, particularly those with atypical Pap cytology results or positive high-risk HPV tests. The CINtec PLUS Cytology Kit is CE-IVD marked for in vitro diagnostic use and features a streamlined process with pre-prepared monoclonal antibodies that ensure accurate detection while supporting efficient laboratory workflows.
By enabling the objective classification of transforming HPV infections, this assay empowers clinicians to make informed decisions about follow-up procedures like colposcopy, ultimately improving patient management and clinical outcomes. Roche is committed to innovation in diagnostics, aiming to provide solutions that enhance early detection and treatment for cervical cancer, while ensuring comprehensive support and training for laboratory professionals
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