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SHOP
Study Highlights: Enhancing HPV Diagnosis with p16/Ki67 Dual Staining
2025-06-20This 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
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