The importance of combined HPV and CINtec® PLUS genotyping testing for p16 in women with cervical squamous cell...

Area of Science:

• Gynecologic Pathology
• Oncology
• Virology

Background:

• Immunohistochemistry (IHC) for p16INK4A (p16) serves as a reliable surrogate for high-risk human papillomavirus (HPV) infections.
• Persistent HPV infection can cause significant changes in cervical cells, necessitating accurate detection methods.

Purpose of the Study:

• To evaluate cervical cell changes associated with persistent HPV infection.
• To compare the efficacy of IHC for p16 protein with HPV genotyping in detecting HPV infection.

Main Methods:

• The study involved female patients aged 26-57 presenting with gynecological complaints.
• Cervical samples underwent cytological testing, IHC for p16, and HPV genotyping.

Main Results:

• A statistically significant correlation (p=0.0001) was found between HPV and p16 status.
• High agreement (weighted kappa: 0.951) was observed between HPV positivity (53.7%) and p16 positivity (56.1%).
• CINtec® PLUS p16 testing demonstrated high positive predictive value (95.7%) and negative predictive value (100%) for HPV detection.

Conclusions:

• The p16 marker (CINtec® PLUS) is a valuable prognostic biomarker for triaging women at risk of precancerous cervical lesions.
• p16 testing offers improved sensitivity and specificity compared to morphology-based cytology.
• While HPV testing is highly sensitive, p16 offers a clinically useful alternative with high sensitivity and specificity.