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Clinical Value of P16/Ki67 Dual Staining in Diagnosing HPV-Related Oropharyngeal Cancer

2024-02-01

By celnovte

This study evaluated 153 cases of oropharyngeal squamous cell carcinoma (OPSCC) using three diagnostic methods:

– p16 immunohistochemistry (IHC)

– p16/Ki67 dual immunostaining

– HPV RNA in situ hybridization (gold standard)

Key Findings:

When the p16/Ki67 dual-positive index was ≥40%, diagnostic accuracy for HPV-positive OPSCC was highest.
Only 58.1% of p16-positive cases were confirmed as HPV-positive, showing the limitations of p16 alone.

Clinical Relevance

In regions with lower HPV prevalence, such as China, p16 alone often leads to a high false-positive rate. The p16/Ki67 dual stain offers higher diagnostic specificity by identifying both HPV infection and tumor cell proliferation.

A 40% dual-positive threshold improves diagnostic accuracy and supports tumor grading and treatment planning.

Product Demonstration

Recommended Product: Celnovte P16/Ki67 Dual Staining Solution

The Celnovte P16/Ki67 Dual Staining Kit is validated for diagnosing and stratifying HPV-related conditions such as:

– HPV-positive oropharyngeal cancer

– Cervical intraepithelial neoplasia (CIN)

– Other HPV-associated epithelial lesions

Key Advantages

– Dual-color chromogen system: Clear marker differentiation

– Ready-to-use reagents: Reduced prep time, increased lab efficiency

– High sensitivity and specificity: Backed by peer-reviewed clinical research

For optimal results, use with Celnovte automated IHC stainers (CNT300, CNT320, CNT360).

Contact Us

Request brochures, sample kits, or validated protocols.

Celnovte — empowering pathology labs with precision diagnostic tools and trusted performance.

Email: info@celnovte.com
Website: www.celnovte.com

Reference

Zhang Y, Gu T, Qian JJ, et al. Application of p16/Ki-67 dual immunostaining in the diagnosis of HPV-positive oropharyngeal squamous cell carcinoma. Chinese Journal of Stomatology, 2023, 58(3):244–250. DOI: 10.3760/cma.j.cn112144-20221220-00627