CINtec® PLUS Cytology Kit (BenchMark, CE-IVD)

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DIAGNOSTICS F. Hoffmann-La Roche Ltd

CINtec® PLUS Cytology Kit

CINtec PLUS Cytology staining
Catalog Number:605-100
Ordering Code:06889565001
Quantity:100 tests
Controls:Specimens processed in the same manner as the patient sample(s) should be used as positive controls. Positive controls are indicative of correctly prepared specimens and proper staining techniques.
Isotypes:p16 - IgG2a, Ki-67 IgG
Species:p16 Mouse Monoclonal antibody, Ki-67 Rabbit Monoclonal antibody
Localization:Cytoplasmic and Nuclear for p16, Nuclear for Ki-67
Regulatory Status:CE-IVD

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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