Roche

@p16ki67dualstain.com

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 patientÂ´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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About Roche

CINtec PLUS is a specialized brand under Roche Diagnostics, dedicated to enhancing cervical cancer screening through innovative diagnostic solutions. The cornerstone of their offering is the CINtec PLUS Cytology Kit, an advanced immunocytochemistry assay that simultaneously detects the p16INK4a and Ki-67 proteins in cervical cytology samples. This dual-biomarker technology serves as a critical aid in identifying women with high-grade cervical intraepithelial lesions, particularly in those with atypical Pap smear results or positive high-risk HPV tests.

Designed for in vitro diagnostic use, the CINtec PLUS Cytology Kit empowers healthcare professionals by providing precise and actionable insights, allowing for informed decisions about follow-up procedures. By effectively diagnosing transforming HPV infections, the CINtec PLUS helps reduce unnecessary procedures while ensuring that patients who need further evaluation are prioritized. Through continuous innovation, CINtec PLUS strives to improve clinical outcomes and provide certainty in cervical cancer screening, ultimately enhancing patient care.