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

Kit Size: 12 Tests/kit
Catalog No.: TB001
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 KRAS Gene Mutation Detection Kit is a sensitive and selective assay for the qualitative detection of 7 types of KRAS mutations at the 12th and 13th codon of exon 2 (about 90% frequency).  Studies have shown that patients with those mutations in the KRAS gene present in their tumors are often unable to benefit from the EGFR targeted therapy. The kit is used for in-vitro testing only.
Technological Principles:
ACCB’s KRAS Gene Mutation Detection Kit is a real-time polymerase chain reaction (PCR)-based assay that uses mutant-specific primers to identify 7 mutations in the KRAS 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 KRAS Gene Mutation Detection Kit detects the following KRAS mutations:

Gly12Asp (GGT>GAT)、Gly12Ala (GGT>GCT)、Gly12Val (GGT>GTT)、Gly12Ser (GGT>AGT)、Gly12Arg (GGT>CGT)、Gly12Cys (GGT>TGT)、Gly13Asp (GGC>GAC) 
Key Features and Benefits:
◆ ACCB’s KRAS Gene Mutation Detection Kit detects 7 mutations at the 12th and 13th codon in exon 2 of the KRAS 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 7 types of KRAS 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 KRAS gene mutations only, not for genotyping purposes. 
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