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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 is an innovative brand that specializes in advanced diagnostics for cervical cancer screening. Their flagship product, the CINtec PLUS Cytology Kit, is an immunocytochemistry assay designed for the dual detection of p16INK4a and Ki-67 proteins in cervical cytology preparations. This cutting-edge test assists healthcare professionals in identifying women at risk for high-grade cervical intraepithelial lesions, particularly in those with atypical Pap results or high-risk HPV positives.
The CINtec PLUS Cytology Kit employs dual-biomarker technology, enabling accurate and simultaneous assessment, which enhances screening efficacy and minimizes misdiagnosis. It provides immediate actionable results, empowering clinicians to recommend appropriate follow-up procedures, such as colposcopy, for patients who need additional evaluation. As a CE-IVD certified product intended for in vitro diagnostic use, CINtec PLUS exemplifies Roche Diagnostics' commitment to improving women's health management through enhanced screening approaches and innovative diagnostic solutions. This helps ensure that women receive the care and attention necessary for timely intervention and better health outcomes.
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