CINtec® Histology
)
The CINtec® Histology kit is an immunohistochemistry assay for the qualitative detection of the p16INK4a antigen on slides prepared from formalin-fixed, paraffin-embedded cervical biopsies. p16INK4a is a biomarker directly indicating the oncogenic activity of High Risk Human Papilloma Virus (HR-HPV) that may result in 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® Histology assay is applied to standard formalin-fixed, paraffin-embedded tissue sections either from cervical punch biopsies, or from conization specimens. Based on a two-step immunohistochemistry protocol, p16INK4a over-expression in cervical lesions is visualized as a brown colour precipitate. The CINtec® Histology kit adds distinctive biomarker information to the interpretation of H&E stains. It aims to provide an objective, reproducible and specific tool for improving the cervical intraepithelial neoplasia (CIN) diagnosis.
The CINtec® Histology assay is based on the specifically designed antibody clone E6H4™ as the method for identifying p16INK4a in histological specimens. The sensitivity and specificity of the E6H4™ antibody clone has been established and validated through over 50 clinical research studies. 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 ready-to-use p16INK4a antibody (clone E6H4™) and Negative Reagent Control, peroxidase-blocking reagent, epitope retrieval solution and visualization reagent and wash buffer .
The kit is intended to be used in medical pathology laboratories. Interpretation of the test results may only be made by a certified professional in conjunction with the patient´s clinical history and any additional diagnostic tests that have been performed.
Interpretation of the test results may be made only by a certified professional taking into account the patient's clinical history as well as the results from other diagnostic tests. The kit is for manual and automated use. Please contact mtm to get a list of instruments the kit is validated for.
Intellectual property
The CINtec® p16INK4a Histology kit is 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.
Literature
The literature is quite extensive regarding the performance of immunohistostaining for p16INK4a across a wide range of clinical challenges in cervical biopsy diagnosis. CINtec® Histology in conjunction with H&E has been shown to increase both the accuracy and inter-observer agreement for diagnosing cervical cancer.
CINtec® p16INK4a Histology Manual
As a special service mtm AG will send you the CINtec® p16INK4a Histology 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 Histology 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® Histology Kit Insert
CINtec® Histology V-Kit Insert
CINtec® Histology Protocol Piece for manual use
CINtec® Histology Protocol Piece for automated use
CINtec® Histology Material Safety Data Sheet
CINtec® Wash Buffer Material Safety Data Sheet
The CINtec® Histology assay is applied to standard formalin-fixed, paraffin-embedded tissue sections either from cervical punch biopsies, or from conization specimens. Based on a two-step immunohistochemistry protocol, p16INK4a over-expression in cervical lesions is visualized as a brown colour precipitate. The CINtec® Histology kit adds distinctive biomarker information to the interpretation of H&E stains. It aims to provide an objective, reproducible and specific tool for improving the cervical intraepithelial neoplasia (CIN) diagnosis.
The CINtec® Histology assay is based on the specifically designed antibody clone E6H4™ as the method for identifying p16INK4a in histological specimens. The sensitivity and specificity of the E6H4™ antibody clone has been established and validated through over 50 clinical research studies. 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 ready-to-use p16INK4a antibody (clone E6H4™) and Negative Reagent Control, peroxidase-blocking reagent, epitope retrieval solution and visualization reagent and wash buffer .
The kit is intended to be used in medical pathology laboratories. Interpretation of the test results may only be made by a certified professional in conjunction with the patient´s clinical history and any additional diagnostic tests that have been performed.
Interpretation of the test results may be made only by a certified professional taking into account the patient's clinical history as well as the results from other diagnostic tests. The kit is for manual and automated use. Please contact mtm to get a list of instruments the kit is validated for.
Intellectual property
The CINtec® p16INK4a Histology kit is 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.
Literature
The literature is quite extensive regarding the performance of immunohistostaining for p16INK4a across a wide range of clinical challenges in cervical biopsy diagnosis. CINtec® Histology in conjunction with H&E has been shown to increase both the accuracy and inter-observer agreement for diagnosing cervical cancer.
CINtec® p16INK4a Histology Manual
As a special service mtm AG will send you the CINtec® p16INK4a Histology 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 Histology 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® Histology Kit Insert
CINtec® Histology V-Kit Insert
CINtec® Histology Protocol Piece for manual use
CINtec® Histology Protocol Piece for automated use
CINtec® Histology Material Safety Data Sheet
CINtec® Wash Buffer Material Safety Data Sheet
® mtm laboratories AG, all rights reserved