Oral squamous cell carcinoma is a common and frequently-occuring disease, which seriously endangers human physical and mental health. Early detection of precancerous lesions is of great significance for the prognosis of oral squamous cell carcinoma. The occurrence and development of oral squamous cell carcinoma is a progresive process, which is a multi-gene and multi-step carcinogenic process, including the activation of oncogenes and the inactivation of tumor suppressor genes, relative to normal tissue cells.

【Intended use】

This kit is suitable for in vitro qualitative detection of three specified ongogene RNA expression in human oral clinical samples. This kit is suitable for the auxiliary diagnosis of oral squamous cellcarcinoma biopsy and exfoliated cells recommended by clinicians, and provides patients with more choices of auxiliary diagnosis methods for oral squamous cell carcinoma.The clinician should make a comprehensive judgment on the test results by combining the patient's condition and other laboratory test indicators.

【Detection principle】

In this kit, multiple real-time fluorescent RT-PCR technology based on fluorescence probe method was used to detect three human genes and human butler genes in a single tube.The human β-actin gene is used as an internal reference (IC) to monitor sampling quality. Meanwhile, this kit uses UDG enzyme to prevent nucleic acid contamination.

【Clinical performance】

The clinical performance ofthis gene detection kit was verified by three clinical centers, including the Ninth People's Hospital Affiliated to the School of Medicine of Shanghai Jiao Tong University, the Beijing Stological Hospital Affiliated to Capital Medical University, and the Nanjing University Afiliated Stomatological Hospital, with a large sample of oral cancer tissue and control tissue, showed that the area under the curve (AUC) of the kit for the detection of oral cancer tisue in the subjects reached above 0.96, and sensitivity and specificity of the diagnosis of oral cancer and precancerous lesions of the mucosa at different clinical stages were both over 90%, indicating that it is reliable early auxiliary diagnostic product for oral cancer.