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Literature Spotlight | Clinical Value of P16/Ki67 Dual Staining in Diagnosing HPV-Related Oropharyngeal Cancer
2025-06-20🧪 Study Highlights: Enhancing HPV Diagnosis with p16/Ki67 Dual Staining
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
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