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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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#0B42CA
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11, 66, 202
223, 90, 42
95, 67, 0, 21
#FFFFFF
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255, 255, 255
0, 0, 100
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#000000
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0, 0, 0
0, 0, 0
0, 0, 0, 100
CINtec PLUS Cytology Kit, developed by Roche Diagnostics, is an innovative immunocytochemistry assay designed for the qualitative detection of p16INK4a and Ki-67 proteins in cervical cytology preparations. This advanced diagnostic tool aids in identifying women at risk for high-grade cervical intraepithelial lesions, particularly those with ASC-US or LSIL Pap results, or positive high-risk HPV test outcomes. The kit employs dual-biomarker technology, offering a reliable method to detect transforming HPV infections by evaluating the co-expression of p16 and Ki-67 in the same cell, which is strongly indicative of high-grade disease.
CINtec PLUS is intended for in vitro diagnostic use and supports healthcare professionals in their screening efforts by providing immediate, actionable results that enhance patient management. This timely triage test is designed to reduce unnecessary follow-up visits while ensuring that women who require further evaluation, such as colposcopy, are promptly identified. With a commitment to improving clinical outcomes, Roche Diagnostics offers cutting-edge solutions for cervical cancer screening and diagnosis.
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