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(Real-time PCR assay)
CE-IVD
PAX1 GENE METHYLATION ASSOCIATED WITH CERVICALCANCER
Abnormal methylation of PAX1 gene can reflect the pathological process of cervical cancer and precancerous lesions of different stages. It is closely related to the occurrence and progression of cervical cancer. Its detection of precancerous lesions or cervical cancer can be early than conventional Thinprep cytologic test. (TCT). PAX1 gene methylation detection combined with HPV and TCT detection will help increasing the detection rate of cervical cancer.
CERVICAL CANCER RELATED SCREENING TECHNOLOGY
Methodology | Technical | Technical Characteristic |
Traditional cervical smear ( Pap Smear) | Scrape the epithelial cells in the cervix with a scraper, apply evenly on the glass slide,fix and stain. | Lower cost: Due to human factors in the acquisition, production, and reading, the results are limited. This method has gradually been eliminated. |
Thinprep cytologic test(TCT) | The obtained exfoliated cells from cervical secretions are collected and immersed in liquid cell processing reagents, and then exfoliated cell slices are made. After staining, the cell morphology of the cervix can be checked by manual observation and analysis to diagnose cervical cancerand itsprecancerous changes. | Convenient sampling and breakthrough in production technology; Need manual observation and analysis of cell morphology. Easy to be interfered by human factors. The diagnosis rate of atypical squamous cell smear is not high, often unable to detect cervical cancer. |
Human papillomavirus (HPV) testing | Use DNA amplification and hybridization technology to detect cervical cell samples for HPV infection status and typing, Mainly focus on the typing of high-risk HPV (hr-HPV) such as 16 and 18. | High throughput and sensitivity.Can detect multiple infections, suitable for large-scale clinical screening.Detection of viruses instead of individual genes. Only early warning rather than earlydetection. There is a possibility for false positive. |
PAX1 methylation detection | Detect cervical smear samples for the high-level sensitivity and specify of PAX1 gene Methylation. | Accurate screening at the individual genetic level, safe and reliable.High throughput and sensitivity, strong specificity.The operation is automatic and good repeatability. |
THREE APPROACHES TO CERVICAL CANCER SCREENING AND FUTURE TESTS
Molecular | Cytologic | Visual Inspection |
Nucleic acid amplification tests (NAAT) » high-risk HPV DNA/NAAT » mRNA DNA methylation Protein biomarkers » HPV antibodies » oncoproteins | Conventional Pap smear Liquid-based cytology (LBC) Dual staining to identify p16 and Ki-67 | Visual inspection with acetic acid or with Lugol’s iodine (VIA/VILI) » naked eye » magnified by colposcope or camera Automated visual evaluation of digital images |
WHO guideline for screening and treatment of cervical pre-cancer lesions for cervical cancer prevention, second edition
DETECTION DESIGN OF PAX1 METHYLATION
This kit uses fluorescent PCR amplification technology to qualitatively detect the methylation of PAX1 gene specific sites in DNA samples. Combines with HPV and TCT testing to provide a reference for accurate cervical cancer screening.
Methodology | PAP-ARMS® Technology |
Applicable people | ● Cervical cancer screening or regular assessment ● HPV positive carrier ● Patients with abnormal cervical smear test ● Cervical spine incision, cervical surgery, patient monitoring after radiotherapy and chemotherapy ● People with unexplained vaginal bleeding |
Technological Breakthrough | ● New biomarkers of cervical cancer ● High specificity and sensitivity ● The operation is automatic, simple ,fast, and with good repeatability ● Independent screening, safe and reliable |
RODUCT INFORMATION
Product Name | Core Technology | Pack Size | Instruments Validated | Sample Type |
Human PAX1 Gene Methylation Detection Kit | PAP-ARMS® | 24 Tests/Kit | Stratagene Mx3000P™ ABI7500 etc. | Cervical scraping |
DETECTION PROCESS
1.Nucleic Acid Extraction
2.Modification
3.Set up qPCR
4.Amplification
5.Data Analysis