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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 a cutting-edge diagnostic kit developed by Roche Diagnostics, specifically designed for the screening of cervical cancer. This innovative immunocytochemistry assay allows for the simultaneous qualitative detection of two key proteins, p16INK4a and Ki-67, within cervical cytology samples. It serves as a vital tool in identifying women at risk for high-grade cervical intraepithelial lesions, particularly those with atypical Pap cytology results or positive high-risk HPV test findings.
The CINtec PLUS Cytology Kit not only enhances the accuracy of cervical cancer screening but also aids in the triage of patients, ensuring that those who need follow-up colposcopy receive timely interventions. Utilizing dual-biomarker technology, this test provides definitive results, helping clinicians make informed management decisions and improve patient outcomes. With a focus on in vitro diagnostic use, the CINtec PLUS Cytology Kit exemplifies Roche Diagnostics' commitment to advancing healthcare through innovative diagnostics that prioritize patient safety and clinical efficacy.
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