Product Overview
The Human CDO1 and CELF4 Gene Methylation Detection Kit is an in vitro qualitative diagnostic assay using real-time fluorescent PCR to detect methylation levels of CDO1 and CELF4 genes in human plasma (cell-free DNA). It is designed as a non-invasive blood-based screening and early detection tool for colorectal cancer and advanced adenomas. ### Key Features - **Liquid biopsy approach:** Detects tumor-derived methylated cfDNA from a simple blood draw — no bowel preparation
Key Features & Advantages
- time fluorescent PCR to detect methylation levels of CDO1 and CELF4 genes in human plasma (cell - free DNA). It is designed as a non - invasive blood - based screening and early detection tool for colorectal cancer and advanced adenomas. ### Key Features - - Liquid biopsy approach: - Detects tumor - derived methylated cfDNA from a simple blood draw — no bowel preparation or invasive colonoscopy required for initial screening.
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: quality and PCR integrity. - **Sample type:** Peripheral blood (plasma) collected in cell-free DNA blood collection tubes. - **Platform compatibility:** ABI 7500, Bio-Rad CFX96, Roche LightCycler 480, and similar instruments. ### Clinical Applications - Colorectal cancer screening for average-risk populations (adjunctive to FIT) - Early detection of advanced adenomas and stage I–II CRC - Post-operative minimal residual disease (MRD) monitoring - Screening refusal management — for patients declining colonoscopy ### Comparative Advantage Compared to fecal immunochemical tests (FIT) that detect only bleeding lesions, methylation-based liquid biopsy detects both pre-cancerous adenomas and early cancers at the molecular level. Unlike the FDA-approved Epi proColon (SEPT9), this dual-gene CDO1/CELF4 panel offers improved sensitivity for advanced adenomas (lesions that FIT typically misses). ### Quality & Compliance CE-IVD marked. ISO 13485 certified. Clinical validated in multi-center studies.
sensitivity: for advanced adenomas (lesions that FIT typically misses). ### Quality & Compliance CE-IVD marked. ISO 13485 certified. Clinical validated in multi-center studies.
Frequently Asked Questions
Q: What is the detection limit of this Human CDO1 and CELF4 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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