Clinical Application

• More efficient, accurate and standardized HPV post-primary-screening traige method.
• Assists in screening cervical cancer and diagnosing cervical lesions.
• High diagnostic performance for cervical lesions and cervical cancer, and can be used as an auxiliary molecular marker for the early diagnosis of cervical lesions and cervical cancer.
• Certain guiding significance for the treatment of cervical lesions and cervical cancer.
• Significant clinical advantage on postmenopausal women sample compared with Cytology method.

Intended Use

This kit is a real-time PCR assay for qualitative detection of DNA methylation in gene PAX1, SOX1 and HAS1 in human genomic DNA extracted from cervical sample.

General Specification

Methodology: Real-Time PCR, PCR-Fluorescence Probing
Sample Type: Exfoliate Cervical Cell / LBC Specimen
Analytical Sensitivity: 88.21% (95% CI: 83.39% - 91.77%)
Analytical Specificity: 95.04% (95% CIL 90.11% - 96.58%)
Precision: CV <5%
LoD: 1% of PAX1, HAS1 and SOX1 methylation in the background of 5 ng human genomic DNA

Packing Specifications

Workflow