Description:
The Super-ARMS® EGFR Mutation Detection Kit is a real-time PCR assay. This kit facilitates the qualitative detection of up to 31 somatic mutations in exons 18-21 of the EGFR gene using human circulating DNA extracted from plasma/serum. It is intended to assist in identifying EGFR mutation status in patients with non-small cell lung cancer (NSCLC) who may qualify for approved targeted therapies. The kit is for in vitro diagnostic use and is intended for use by trained professionals in a laboratory setting.
Principle:
The kit adopts Amplification Refractory Mutation System (ARMS) and real-time PCR technology, which comprises specific primers and fluorescent probes to detect EGFR mutations in circulating DNA. During the nucleic acid amplification, the targeted mutant DNA is matched with the bases at 3’ end of the primer, amplified selectively and efficiently, then the mutant amplicon is detected by fluorescent probes labeled with FAM. While the wild-type DNA cannot be matched with specific primers, there is no amplification occurs. Innovative Super-ARMS® technology is upgraded from ARMS technology and its optimized reaction system can rapidly and accurately detect low percentage of mutant ctDNA in a background of wild-type DNA.
High sensitivity: up to 0,2%
Detected mutations:
• Exon 18: G719A, G719C
• Exon 19: 19 deletions
• Exon 20: T790M, S768I, 6 insertions
• Exon 21: L858R, L861Q
Tests/kit: 12 (bulk)
Instrument: Stratagene Mx3000P™, ABI 7300, ABI 7500, ABI 7900HT, ABI StepOnePlus, LightCycler480 II, cobas® z480, Bio-Rad CFX96, SLAN-96S