CINtec® PLUS Cytology

Be certain – Triage with CINtec® PLUS Cytology

CINtec PLUS slide
Cytology: be certain about the presence of a transforming HPV infection

 

The goal of screening is to avoid mis-diagnosis and the over- or under-treatment it causes. While Pap cytology has had a positive impact on HPV and cervical cancer screening over the past 50 years, it is no longer the ideal screening and triage strategy as it lacks accuracy and misses disease.


CINtec® PLUS Cytology is a triage test for cervical cancer screening, and the only test that uses dual-biomarker technology to simultaneously detect p16 and Ki-67 to provide a strong indicator of the presence of transforming HPV infections. CINtec® PLUS Cytology objectively identifies transforming HPV infections in women with abnormal Pap Cytology results and HPV positive cervical cancer screening results, allowing laboratory professionals to help physicians be certain they can recommend follow-up for women who will benefit most from Colposcopy.

Abnormal cytology can’t hide anymore with CINtec® PLUS Cytology

 

Unique dual-biomarker technology makes you certain about the presence of transforming HPV infection.

CINtec® PLUS Cytology is the only test that uses dual-biomarker technology to simultaneously detect p16 and Ki-67 to provide a strong indicator of the presence of transforming HPV infections.

Co-expression of p16 and Ki-67 in the same cell is strongly associated with established high-grade disease.

 

CINtec® PLUS Cytology publications

cobas® HPV Test with CINtec® PLUS Cytology triage could lead to improved clinical outcomes
  • Clinicians use screening and triage tests to identify the risk of disease and can manage women based on their level of risk.
  • Various combinations of screening and triage tests can result in differences in disease detection and the number of colposcopies required.
  • A strategy that results in more disease detection without increasing the colposcopy rate can aid clinicians making decisions that result in improved clinical outcomes and lower healthcare costs.
Data analysis of CINtec PLUS Cytology triage results for women positive with cobas HPV 16 or HPV 18 or 12 other hrHPV genotypes

Additional information, from the same sample collected for HPV DNA or Pap screening, helps ensure women are not lost to follow-up

 

  • CINtec® PLUS Cytology provides immediate and actionable triage results
  • Reduces both the number and frequency of follow-up visits required
  • Gives women clear answers and certainty in their test results
CINtec® PLUS Cytology is a triage test for cervical cancer screening
CINtec PLUS Cytology positive dual stain result showing co-expression of biomarkers p16 & Ki-67 immunocytochemistry
Pap cytology triage flowchart including CINtec PLUS Cytology p16 & Ki-67 objective dual stain biomarker technology
An objective biomarker triage test for ASC-US and LSIL, abnormal Pap cytology screening results

 

CINtec® PLUS Cytology identifies underlying transforming HPV infections in women with abnormal Pap cytology results to send the women who will benefit most from colposcopy for follow-up testing.

CINtec® PLUS Cytology outperforms Pap cytology as the triage test for HPV (+) screening results

Primary HPV screening and Pap cytology co-testing triage flowchart incl CINtec PLUS Cytology

For HPV16/18+ triage, use in conjunction with the physician’s assessment of patient screening history, other risk factors, and professional guidelines to guide patient management

An objective biomarker triage test with high sensitivity and specificity

 

cobas® HPV DNA test with triage using CINtec® PLUS Cytology detects transformig HPV infections and helps avoid unnecessary colposcopy for women who do not need it immediately.

An objective biomarker test to help triage Pap negative/HPV (+) co-testing results

Improve management of women with Pap cytology negative/HPV (+) results: In co-testing, CINtec® PLUS Cytology provides immediate and actionable results to help reduce the number of women lost to follow-up testing.

CINtec® PLUS Cytology reduces diagnostic variability and uncertainty to impact timely patient management
  • The test indicates oncogenically transforming HPV infections, and thus eliminates equivocation over morphologic abnormalities that are not pre-cancerous. Very good overall clinical accuracy has been demonstrated in key cervical cancer screening scenarios.
  • Overall, p16/Ki-67 dual staining has the potential to significantly reduce the number of women referred for confirmatory colposcopy.
Pap Cytology ASC-US result triage using CINtec PLUS Cytology; sensitivity and specificity data
Pap Cytology LSIL result triage using CINtec PLUS Cytology; sensitivity and specificity data
Pap Cytology and HPV co-testing triage for Pap normal/HPV positive women using CINtec PLUS Cytology; sensitivity and specificity data
HPV primary screening triage for high risk HPV positive women using CINtec PLUS Cytology; sensitivity and specificity data
The benefit of CINtec PLUS Cytology triage in multiple cervical cancer screening scenarios

Currently, the CINtec® PLUS Cytology test is included in guidelines in Ecuador, France, Germany, Hong Kong, Portugal, South Africa, and Spain.

Advanced dual-biomarker technology that integrates with automated testing procedures to improve efficiency
Advanced dual stain biomarker technology is compatible across the Benchmark systems portfolio with various sample collection media types.

 

Physicians can more effectively triage and manage patients with CINtec® PLUS Cytology

 

 

Related information


CINtec® PLUS Cytology  is a dual-stain immunocytochemistry test for the biomarkers p16 and Ki-67. The assay is run on the BenchMark ULTRA IHC/ISH system, as well as BenchMark GX and the legacy Benchmark XT system. For technical documentation, or training support, please click here.

BenchMark ULTRA system is Roche Tissue Diagnostics’ most innovative, fully-automated immunohistochemistry and in situ hybridization slide staining system, offering multiple features designed to deliver diagnostic confidence to histopathology laboratories worldwide.

BenchMark GX offers a fully automated baking-through-staining solution with the added flexibility to run any assay side-by-side.

BenchMark ULTRA instrument benefits

Fully automated

  • Standardized IHC and ISH staining

  • Improve quality, workflow and testing efficiency

 

Flexibility

  • Individually controlled slide heater pads enable users to run any assay side-by-side

  • Customize time and temperature protocols for each individual slide position

 

Optimal quality

  • Individual slide heaters, liquid coverslip and air vortex mixers provide an optimal puddle staining environment

  • Sensitive detection chemistries and a broad portfolio of ready-to-use assays 

 

 Workflow

  • Optimize throughput capacity with single piece workflow

  • Increase laboratory productivity and reduce re-run rates

 

 BenchMark ULTRA instrument features

  • 30 slide positions

  • Ability to add or remove bulk reagents and waste without interrupting cases in process

  • 35 reagent positions

  • Continuous and random slide processing to optimize laboratory workflow 

 

Learn more about the BenchMark ULTRA system  

Learn more about BenchMark GX system

CINtec® PLUS Cytology Accessories Information


CINtec® PLUS Cytology  is a dual-stain immunocytochemistry test for the biomarkers p16 and Ki-67. The assay is run on the BenchMark ULTRA IHC/ISH system, as well as BenchMark GX and the legacy Benchmark XT system. For technical documentation, or training support, please click here.

BenchMark ULTRA system is Roche Tissue Diagnostics’ most innovative, fully-automated immunohistochemistry and in situ hybridization slide staining system, offering multiple features designed to deliver diagnostic confidence to histopathology laboratories worldwide.

BenchMark GX offers a fully automated baking-through-staining solution with the added flexibility to run any assay side-by-side.

 

BenchMark ULTRA IHC/ISH System

 

Rated #1 for staining quality and platform reliability, this fully automated instrument offers 30 independent slide drawers and single-piece workflow—supporting the largest menu of 250+ ready-to-use assays.

 

Learn More
IHC Stain Automation—BenchMark Ultra pathology lab instrument Ventana

 

BenchMark GX IHC/ISH System

 

BenchMark GX offers a fully automated baking-through-staining solution with the added flexibility to run any assay side-by-side.

Learn More
Ventana-BenchMark-Image 3-XT