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CINtec® PLUS Cytology Kit

CE-IVD

IVD For in vitro diagnostic use.
CINtec<sup>®</sup> <i>PLUS</i> Cytology Kit

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

The goal of screening is to detect potential diseases or conditions before they occur while avoiding misdiagnosis and the over-and under-treatment it can cause. While Pap cytology has had a positive impact on HPV and cervical cancer screening over the past 50 years, it is resource-intensive and subject to misinterpretation and missed 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 positive dual stain result showing co-expression of biomarkers p16 & Ki-67 immunocytochemistry

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

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CINtec® PLUS Cytology is a triage test for cervical cancer screening

Pap cytology triage flowchart including CINtec PLUS Cytology p16 & Ki-67 objective dual stain biomarker technology

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

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.

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 transforming 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

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

HPV (+) triage

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

 

Pap Cytology (-) HPV (+) triage

CINtec® PLUS Cytology can detect the cervical disease that Pap cytology misses

 

ASC-US cytology triage

CINtec® PLUS Cytology may reduce the number of women that require referral to colposcopy compared with HPV testing in the ASC-US population

 

LSIL cytology triace

Where the only current management option is colposcopy, CINtec® PLUS Cytology can detect those women where no colposcopic referral is needed

 

Younger women

Where transient HPV infections are more prevalent, CINtec® PLUS Cytology may reduce the number of unneeded colposcopy referrals

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.

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      IVD For in vitro diagnostic use.
      CINtec<sup>®</sup> <i>PLUS</i> Cytology Kit
      CINtec® PLUS Cytology Kit Japan
      IVD For in vitro diagnostic use.
      CINtec<sup>®</sup> <i>PLUS</i> Kit
      CINtec® PLUS Kit CE-IVD The CINtec® PLUS Kit is an immunocytochemistry assay for the simultaneous qualitative detection of the p16INK4a and Ki-67 proteins in cervical cytology preparations.It is intended 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.The kit is intended to be used in medical cytology laboratories. 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 test is intended for manual use, or for use on Autostainer instruments.
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