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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 product from Roche Diagnostics that revolutionizes cervical cancer screening through its dual-biomarker technology. This immunocytochemistry assay enables the simultaneous qualitative detection of the p16INK4a and Ki-67 proteins in cervical cytology preparations, aimed at identifying women with high-grade cervical intraepithelial lesions. Specifically designed for in vitro diagnostic use, the CINtec PLUS Cytology Kit assists healthcare professionals in triaging patients with abnormal Pap results, such as ASC-US and LSIL, as well as those who test positive for high-risk HPV.
With a focus on providing reliable results, this assay employs a unique cocktail of monoclonal antibodies and optimized detection systems to ensure accurate readings. The results aid in determining the necessity of further diagnostic procedures, ultimately enhancing patient management and improving clinical outcomes. By offering clear and actionable insights, CINtec PLUS Cytology ensures that women receive the necessary follow-up while minimizing potential over-treatment and enhancing the overall efficiency of cervical cancer screenings.
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