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Human BRAF Gene Mutation Detection Kit (Real-time Fluorescent PCR)

Kit Size: 24 Tests/kit
Catalog No.: TB004
Sample Type: Paraffin-embedded tissue, fresh tumor tissue, fresh frozen tumors, blood, pleural effusion, etc.
qPCR Instrument: Stratagene Mx3000P/3005P, ABI 7300/7500/7900/Viia7/StepOne/ StepOne Plus, Roche LC480, Abbott m2000rt, Bio-Rad CFX96/IQ5.
 ACCB’s BRAF Gene Mutation Detection Kit is a sensitive and selective assay for the qualitative detection of BRAF V600E mutation in exon 15 (80-90% frequency). Studies have shown that patients with BRAF V600E mutation often cannot benefit from EGFR-targeted therapy. The kit is used for in-vitro testing only. 
Technological Principles:
ACCB’s BRAF Gene Mutation Detection Kit is a real-time polymerase chain reaction (PCR)-based assay that uses mutant-specific primers to identify the BRAF V600E mutation.  The testing procedure involves three (3) simple steps, which can be completed in approximately 1.5 hours from DNA to test results:

  1. Isolation of DNA from tumor biopsies, paraffin-embedded sections (FFPE), fresh frozen tumors, or tumor cell lines, etc.
  2. PCR setup completed with reagents included in the kit.
  3. qPCR amplification and detection using a real-time PCR instrument. 

Key Features and Benefits:
◆ ISO13485 certified, 3,000 square meters IVD kit manufacturing facility and standard R&D detection laboratory.
◆ CE & CFDA marked, the serial gene mutation detection products of EGFR, KRAS, BRAF, PIK3CA.
◆ International standard of QA/QC system.
◆ High Sensitivity & Specificity.
◆ Reliable & Consistent Performance.
◆ Customers pass EQA (External Quality Assessment) organized by EMQN (The European Molecular Genetics Quality Network) and PQCC (Pathology Quality Control Center).
◆ Simple and easy to follow protocol.
Intended Use:
CFDA approved for clinical use in China and CE marked for IVD use in Europe.
Limitations:
The kit can detect BRAF V600E mutation as low as 1% in 10ng/μl genomic DNA. Sensitivity greatly depends on the extent of fragmentation and quality and integrity of the isolated DNA. This kit is used for the detection of the BRAF Gene Mutation only, not for genotyping purposes. 

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