Figure 2. Detection of human p16INK4a protein.
Figure 3. Detection of human Ki-67 protein
Not every HPV-positive woman will develop cervical cancer, so triage can determine who is most at risk and will benefit from more immediate follow-up, and who is at low risk and can be given more time to clear the infection on her own. CINtec PLUS is a triage cytology test that helps stratify disease risk immediately, giving clinicians confidence when selecting the appropriate management for women at every level of risk.
The CINtec PLUS Cytology test is the only FDA approved triage test that uses dual biomarker technology to simultaneously detect p16 and Ki-67 in women with HPV-positive results.
The co-expression of these two biomarkers within the same cell is a strong indicator that an HPV infection is undergoing oncogenic transformation.
CINtec PLUS Cytology is approved for use on cobas® 4800/6800/8800 instruments.
The IMPACT Trial:
The landmark registational cervical cancer portfolio trial
Risk of disease in Pap normal/HPV+ women (≥CIN2, age 30-65)
CINtec PLUS Cytology provides further risk stratification in 12 other HPV+ women
The addition of the CINtec PLUS Cytology test can provide a more accurate quantification of a woman's risk for high grade disease.
Increased testing sensitivity
When added as a triage to discrepant co-testing results, CINtec PLUS Cytology identified 7 our of 10 women as having cells undergoing oncogenic transformation allowing identification of disease earlier in their screening process.
Percentage of disease detected with CINtec PLUS in Pap normal/HPV+ women (≥CIN2, age 30-65)
CINtec PLUS Cytology offers greater sensitivity compared to Pap cytology
CINtec PLUS Cytology improves disease detection independent of genotype, patient age, or vaccination status.
Percentage of disease detected with CINtec PLUS (≥CIN2, age 25-65)
CINtec PLUS Cytology is performed from the same ThinPrep sample as HPV and Pap tests, and run on the BenchMark ULTRA. The BenchMark ULTRA system is a fully automated immunohistochemistry and in situ hybridization slide staining system, offering multiple features designed to provide diagnostic confidence to histopathology laboratories worldwide. With 30 independent slide drawers, the system gives histotechnologists continuous random access and supports single-piece workflow, which numerous studies have shown improves laboratory operational efficiency.
The following publications provide further evidence of the clinical utility of p16/Ki-67 dual staining in cervical cancer screening:
Complete this form if you would like more information about implementing CINtec PLUS Cytology in your lab
Here is a checklist of what you need to implement CINtec PLUS Cytology in your lab:
☐ VENTANA BenchMark ULTRA instrument with required software
☐ Required bulks and ancillaries
| BenchMark ULTRA | |
|---|---|
| Ordering code | Material description |
| 5424534001 | ULTRA LCS |
| 5353955001 | Reaction Buffer Concentrate (10X) |
| 5424569001 | ULTRA CCI |
| 5266726001 | Hematoxylin |
| 5266769001 | Bluing reagent |
| Supplies required but not provided | ||
|---|---|---|
| Part of Catalogue # | Vendor | Material description |
| 70126-002 | Hologic | ThinPrep® Arcless Microscope Slides or ThinPrep® Microscope Slides for Special Processing—75 slides/box |
| 1001350487 | Sigma | CC Mount™ aqueous mounting media |
☐ 25-30 residual HSIL or known positive ThinPrep® sample vials and/or SurePath™ cell pellet tubes
☐ Schedule lab implementation & training with a Roche expert
Training includes:
IHC and ISH reagents and ancillaries
To view associated reagents, ancillaries and bulks, please visit the Roche Tissue Diagnostics reagent catalog.
