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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 Kit is a cutting-edge immunocytochemistry assay designed for the simultaneous detection of the p16INK4a and Ki-67 proteins in cervical cytology samples. This innovative kit aids in identifying women at risk for high-grade cervical intraepithelial lesions, particularly those with ambiguous Pap results like ASC-US or LSIL, and those testing positive for high-risk HPV. Intended for in vitro diagnostic use, the CINtec® PLUS Cytology Kit employs dual-biomarker technology that enhances accuracy in screening for transforming HPV infections.
The kit consists of a ready-to-use cocktail of primary monoclonal antibodies and proprietary detection systems to provide distinct chromogenic signals for p16INK4a and Ki-67, which are evaluated using light microscopy. By leveraging this dual-target approach, healthcare professionals can make informed decisions regarding necessary follow-up procedures, such as colposcopy, ensuring patients receive appropriate care without unnecessary interventions. Overall, CINtec® PLUS Cytology supports improved clinical outcomes in cervical cancer screening and diagnosis.
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