Triage tests for cervical cancer screening results

It is an immunocytochemistry assay used to screen for and aid in the early diagnosis of cervical cancer. This is an important step forward in the management of HPV-positive cases, helping to stratify the risk and provide appropriate treatment for patients.

The principle of assay is based on the simultaneous detection of two important biomarkers in the same cell, p16INK4a (p16) and Ki-67. The simultaneous expression of both p16 (usually in the cytoplasm) and Ki-67 (only in the nucleus) in the same cell is an indication that HPV infection is causing high levels of cellular changes (precancerous) and is at risk of progressing to cancer.

The test is indicated for use primarily as a stratified test in the following cases:

• Women with positive HPV test results for high-risk types.
• Aids in identifying women with high-grade cervical epithelial lesions, Pap cytology results as ASC-US or LSIL

Outstanding advantages:

• High sensitivity in precancerous detection: Proven to have higher sensitivity than traditional Pap tests in detecting high-grade cervical pre-cancerous lesions, especially in women with positive high-risk HPV test results. This leads to earlier disease detection, increasing the chances of successful treatment.
• Helps to accurately stratify risk: By identifying the co-expression of p16 and Ki-67, this test provides clearer information about the risk of disease progression. This helps clinicians make more appropriate patient management decisions (e.g., immediate colposcopy versus routine follow-up).
• Reduces Unnecessary Colposcopies: By effectively stratifying risk, the test helps reduce the number of HPV-positive patients who undergo unnecessary colposcopies, thereby alleviating patient anxiety and costs.
• Increases Positive Predictive Value: Helps more accurately identify HPV-positive cases that are truly causing pre-cancerous lesions, rather than just transient HPV infections.
• Uses the Same Sample: This test can be performed on the same liquid-based sample already collected for HPV or traditional Pap tests, eliminating the need for a repeat collection.
• Automation: The test is typically performed on automated staining systems, which helps standardize the process and minimize errors.