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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, developed by Roche Diagnostics, is an advanced immunocytochemistry assay designed to enhance cervical cancer screening. This innovative kit simultaneously detects two critical biomarkers, p16INK4a and Ki-67, in cervical cytology preparations, facilitating the identification of women with high-grade cervical intraepithelial lesions. It effectively targets populations with atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesions (LSIL), alongside those with positive high-risk HPV test results.
The CINtec PLUS Cytology Kit comes equipped with proprietary monoclonal antibodies and optimized detection systems, yielding clear chromogenic results that can be evaluated microscopically. These results not only assist in determining follow-up strategies for affected women but also aim to reduce unnecessary colposcopies, thereby improving clinical outcomes and patient care. As a CE-IVD certified in vitro diagnostic tool, CINtec PLUS stands at the forefront of cervical cancer triage, ensuring reliable and actionable insights for healthcare professionals.
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