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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 an advanced immunocytochemistry assay developed by Roche Diagnostics, specifically designed for cervical cancer screening. This innovative kit enables the simultaneous qualitative detection of two critical biomarkers, p16INK4a and Ki-67, from cervical cytology samples. Approved for in vitro diagnostic (IVD) use, CINtec® PLUS serves as a valuable tool in identifying women with high-grade cervical intraepithelial lesions, particularly among those with atypical Pap results or high-risk HPV infections.
Roche's unique dual-biomarker technology enhances the certainty of diagnoses and aids healthcare professionals in making informed decisions regarding patient follow-up, including colposcopy referrals. The assay utilizes a dual algorithm with specially formulated monoclonal antibodies to produce precise staining, enhancing the accuracy of test results evaluated by certified technicians. By streamlining the screening process, CINtec® PLUS not only assists in detecting transforming HPV infections but also reduces unnecessary follow-ups, ultimately improving clinical outcomes and patient care in cervical cancer management.
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