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NRAS Mutation Detection Kit

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8.01.0172

CE-IVDD

24 tests per kit

up to 1% sensitivity

Description:

AmoyDx® NRAS Mutation Detection Kit is a real-time PCR assay for in vitro diagnostics (IVD). This kit enables qualitative detection of up to 16 somatic mutations in codons 12, 13, 59, 61, 117 and 146 of the NRAS gene in human DNA extracted from formalin-fixed paraffin-ded (FFPE) tissue samples. It is intended to aid in the identification of NRAS mutation status for colorectal cancer patients who may be eligible 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 NRAS mutations in human genomic 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.

 

High sensitivity: up to 1%
 

Detected mutations:

G12D (35G>A), G12S (34G>A), G13D (38G>A), G13R (37G>C), G12C (34G>T), G12V (35G>T), G12A (35G>C),  G13V (38G>T), A59D (176C>A),  Q61R (182A>G), Q61K (181C>A), Q61K (181C>A), Q61L (182A>T), Q61H (183A>C), K117N (351G>C, 351G>T), A146T (436G>A)

 

Tests/kit: 24 (bulk)

 

Instrument: Stratagene Mx3000P™, ABI 7500, LightCycler480 II, Bio-Rad CFX96, SLAN-96S

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