CINtec® Cytology


The CINtec® Cytology kit is a qualitative, immunocytochemical assay for the evaluation of over-expressed cyclin-dependent kinase inhibitor, p16INK4a protein, on cervical cytology specimens. p16INK4a is a biomarker directly indicating the oncogenic activity of High Risk Human Papilloma Virus (HR-HPV) that marks the generation of cervical cancer. This marks a much more precise means of arriving at a diagnosis of cervical cancer than traditional technologies.

The CINtec® Cytology assay is based on the specifically designed antibody clone E6H4™ as the method for identifying p16INK4a in cytological specimens. The sensitivity and specificity of the E6H4™ antibody clone has been established and validated through over 50 clinical research studies. Importantly, E6H4™ shows no cross reactivity with Trichomonas (a protozoal infection of the vagina) that renders other antibody candidates unacceptable as generating too many false positives. The GMP manufactured kit components in combination with the optimized antibody ensures the reproducible quality and results in assessing a wide variety of biological specimens.

The kit includes a ready-to-use p16INK4a antibody (clone E6H4™), peroxidase-blocking reagent, epitope retrieval solution and visualization reagent and wash buffer..

The CINtec® Cytology Assay has been established for the immunocytochemical staining of cervical cytology preparations. It has been validated to be used for:
  • Liquid-based cytology preparations (cells collected from the cervix are re-suspended in an alcohol-based liquid fixative, and cytological thin-layer preparations are prepared subsequently in the laboratory).
  • Conventional cervical Pap smears (cells are directly transferred from the sampling device to the glass slide and fixed).

Interpretation of results must be made within the context of the patient's clinical history and other diagnostic tests by a certified professional.

Literature
The literature is quite extensive regarding the performance of immunostaining for p16INK4a across a wide range of clinical challenges in cervical cytology preparations. Leading Cytopathologists use CINtec® Cytology in combination with the Pap test when clarification of results is needed.

Intellectual property
The CINtec® p16INK4a kits are based on technology developed by mtm laboratories AG, Germany and based on European Patent 1 092 155 and U.S. Patent 6,709,832; further patents pending.

CINtec® p16INK4a Cytology Manual
As a special service mtm AG will send you the CINtec® p16INK4a Cytology Manual print out if you wish. Just click here and fill in the order form. mtm AG will send the print out shortly after receiving your order to the address provided in the order form.

Ordering
The CINtec® p16INK4a Cytology kit is available on a global basis through mtm's direct operations and distributors and orders can be placed directly through this website.

Downloads
CINtec® Cytology kit Insert
CINtec® Cytology Protocol Piece for manual use
CINtec® Cytology Protocol Piece for automated use
CINtec® Cytology Material Safety Data Sheet
CINtec® Wash Buffer Material Safety Data Sheet



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