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CINtec® Histology is a qualitative immunohistochemistry (IHC) test using mouse monoclonal anti-p16 antibody clone E6H4, and is intended for use in the light microscopic assessment of the p16INK4a protein in formalin-fixed, paraffinembedded (FFPE) cervical punch biopsy tissues using OptiView DAB IHC Detection Kit on a VENTANA BenchMark ULTRA instrument. The test is indicated as an adjunct to examination of hematoxylin and eosin (H&E) stained slide(s), to improve consistency in the diagnosis of cervical intraepithelial neoplasia (CIN). Diagnosis of CIN presence or level should be based on H&E stained slide(s) and other clinical and laboratory test information. Intended for in vitro diagnostic (IVD) use. Prescription Use Only.

CINtec® Histology is a single dispenser immunohistochemical (IHC) assay system comprised of an anti-p16 primary antibody optimized for use with the BenchMark ULTRA automated slide staining instrument and the OptiView DAB IHC Detection Kit. The antibody is diluted in a Tris-HCl buffer containing carrier protein and 0.1% ProClin 300 as a preservative and provided as a ready-to-use liquid in a FloLock dispenser. CINtec Histology is available in a 50-test size and a 250-test size. The OptiView DAB IHC Detection Kit (OptiView) is an indirect, biotin-free system for detecting mouse IgG, mouse IgM, and rabbit IgG primary antibodies and is comprised of 6 dispensers packaged together in one box. Ancillary reagents required to perform the CINtec Histology assay include EZ Prep, Reaction Buffer, ULTRA High Temperature Liquid Coverslip (LCS), ULTRA Cell Conditioning 1 Solution (CC1), Hematoxylin II Counterstain, and Bluing Reagent. Positive and negative tissue controls that are fixed and processed in the same manner as the test specimens should be used when performing this test. A negative reagent control mouse monoclonal antibody shall be used to evaluate nonspecific staining.

CINtec Histology is a qualitative immunohistochemistry (IHC) test using mouse monoclonal anti-p16 antibody clone E6H4. and is intended for use in the light microscopic assessment of the p16thK4a protein in formalin-fixed, paraffin-embedded (FFPE) cervical punch biopsy tissues using OptiView DAB IHC Detection Kit on a VENTANA BenchMark ULTRA instrument. The test is indicated as an adjunct to examination of hematoxylin and eosin (H&E) stained slide(s), to improve consistency in the diagnosis of cervical intraepithelial neoplasia (CIN). Diagnosis of CIN presence or level should be based on H&E stained slide(s) and other clinical and laboratory test information.

The CINtec Histology test is a single dispenser IHC assay system comprised of an anti-p16 primary antibody optimized for use with the BenchMark ULTRA automated slide staining instrument and the OptiView DAB IHC Detection Kit. The antibody is diluted in a Tris-HCl buffer containing carrier protein and 0.1% ProClin 300 as a preservative, and provided as a ready-to-use liquid in a FloLock dispenser. CINtec Histology is available in a 50 test size and a 250 test size. The OptiView DAB IHC Detection Kit (OptiView) is an indirect, biotin-free system for detecting mouse IgG, mouse IgM, and rabbit primary antibodies and is comprised of 6 dispensers packaged together in one box.