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

Kit Size: 12 Tests/kit
Catalog No.: TB002
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 EGFR Gene Mutation Detection Kit is a sensitive and selective assay for the qualitative detection of 45 types of mutations spanning exons 18-21 of the epidermal growth factor receptor (EGFR) gene from adult NSCLC patients, which cover the most informative somatic mutations of the EGFR gene. It is used clinically in China to select NSCLC patients who are most likely to respond to the following chemotherapeutic medications:  Iressa (Gefitinib) , Tarceva (Erlotinib) or Conmana (Icotinbib).  The kit is used for in-vitro testing only.
Technological Principles:
ACCB’s EGFR Gene Mutation Detection Kit is a real-time polymerase chain reaction (PCR)-based assay that uses mutant-specific primers to identify 45 mutations in the EGFR gene. 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 (8 reactions per sample) and detection using a real-time PCR instrument.
Specifications:
ACCB’s EGFR Gene Mutation Detection Kit detects the following key EGFR mutations:

G719S, G719C, G719A、Exon 19 deletions、L858R、L861Q、T790M、S768I、Exon 20 insertions
Key Features and Benefits:
◆ ACCB’s EGFR Gene Mutation Detection Kit detects 45 mutations in Exons 18, 19, 20 and 21 of the EGFR gene.
◆ 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).
◆ Convenient for Operation.
Intended Use:
CFDA approved for clinical use in China and CE marked for IVD use in Europe.
Limitations:
The kit can detect 45 types of EGFR mutations as low as 1% in 10ng/μl of genomic DNA. Sensitivity greatly depends on the extent of fragmentation and quality and integrity of the isolated DNA.  The kit is used for the detection of EGFR gene mutations only, not for genotyping purposes. 

 
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