Product Overview
The Human PAX1 and JAM3 Gene Methylation Detection Kit is an in vitro qualitative diagnostic assay utilizing real-time fluorescent PCR to measure methylation levels of PAX1 and JAM3 genes in cervical exfoliated cell specimens. It serves as an adjunctive triage tool for cervical cancer screening — helping clinicians decide whether a patient with abnormal cytology or positive high-risk HPV requires colposcopy referral. ### Key Features - **Dual-gene methylation panel:** PAX
Key Features & Advantages
- time fluorescent PCR to measure methylation levels of PAX1 and JAM3 genes in cervical exfoliated cell specimens. It serves as an adjunctive triage tool for cervical cancer screening — helping clinicians decide whether a patient with abnormal cytology or positive high - risk HPV requires colposcopy referral. ### Key Features - - Dual - gene methylation panel: - PAX1 and JAM3 — validated biomarkers for high - grade cervical intraepithelial neoplasia (CIN2+) and cervical cancer. -
Clinical Applications
Clinical laboratories, hospitals, public health departments, and diagnostic testing centers for infectious disease detection.
Comparison & Competitive Advantages
Unlike conventional culture methods that require 48-72 hours for results, this real-time PCR kit delivers definitive pathogen detection in under 2 hours. The molecular method offers superior analytical sensitivity, detecting low-copy-number targets that culture may miss.
Technical Specifications
sample: adequacy and PCR inhibition monitoring. - **Sample type:** Cervical exfoliated cells collected in liquid-based cytology medium. - **Workflow compatibility:** Compatible with standard real-time PCR platforms (ABI 7500, Bio-Rad CFX96, Roche LightCycler 480). - **Turnaround time:** Approximately 2.5 hours from DNA extraction to result. ### Clinical Applications - Triage of HPV-positive women to determine need for colposcopy - Adjunctive testing for ASC-US or LSIL cytology results - Risk stratification in cervical cancer screening programs - Post-treatment monitoring for CIN recurrence ### Comparative Advantage Unlike cytology-based triage (Pap smear) that is subjective and operator-dependent, or genotyping-based triage that may over-refer, methylation testing provides an objective molecular-level assessment of oncogenic transformation — potentially reducing unnecessary colposcopies by 30–50% compared to HPV genotyping alone. ### Quality & Compliance CE-IVD marked. ISO 13485 certified. Clinical validated in multi-center trials.
sensitivity: with internal control for sample adequacy and PCR inhibition monitoring. - **Sample type:** Cervical exfoliated cells collected in liquid-based cytology medium. - **Workflow compatibility:** Compatible with standard real-time PCR platforms (ABI 7500, Bio-Rad CFX96, Roche LightCycler 480). - **Turnaround time:** Approximately 2.5 hours from DNA extraction to result. ### Clinical Applications - Triage of HPV-positive women to determine need for colposcopy - Adjunctive testing for ASC-US or LSIL cytology results - Risk stratification in cervical cancer screening programs - Post-treatment monitoring for CIN recurrence ### Comparative Advantage Unlike cytology-based triage (Pap smear) that is subjective and operator-dependent, or genotyping-based triage that may over-refer, methylation testing provides an objective molecular-level assessment of oncogenic transformation — potentially reducing unnecessary colposcopies by 30–50% compared to HPV genotyping alone. ### Quality & Compliance CE-IVD marked. ISO 13485 certified. Clinical validated in multi-center trials.
Frequently Asked Questions
Q: What is the detection limit of this Human PAX1 and JAM3 Gene Methylation Detection kit（Real-time PCR） PCR kit?
A: The kit achieves a limit of detection (LOD) of approximately 5 copies per reaction, enabling sensitive identification of low-level infections. This molecular method is significantly more sensitive than conventional culture or antigen-based approaches.
Q: What sample types are compatible with this kit?
A: This kit is optimized for the appropriate clinical specimen type (e.g., stool, blood, swab). The integrated internal control monitors extraction efficiency and detects PCR inhibition, ensuring reliable results across different sample matrices.
Q: How long does the PCR test take?
A: The real-time PCR assay delivers results in approximately 2 hours, compared to 48-72 hours required for conventional culture-based methods. This enables same-day clinical decisions and faster outbreak response.
Q: What instruments is this kit compatible with?
A: The kit is compatible with mainstream real-time PCR instruments including Applied Biosystems 7500, QuantStudio 5, Roche LightCycler 480, Bio-Rad CFX96, QIAGEN Rotor-Gene Q, and Analytik Jena qTOWER3.
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