BRAF V600E/D/R/K Mutations Detection Kit (Multiplex Real-time PCR)

[REF] UBP-T01548K

[Packing specification] 48Tests/Kit

[Intended use]

UltraDx BRAF V600E/D/R/K Mutations Detection Kit (Multiplex Real-time PCR) is used to qualitatively detect BRAF gene V600 mutations in tumor tissue samples of neutral formaldehyde-fixed paraffin specimens in tumor patients, and provide a reference for clinicians to diagnose and treat patients. The kit is for in vitro diagnostic use, its use requires the operation of a trained professionals in a laboratory environment.

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[Summary]

BRAF encodes a protein belonging to the RAF family of serine/threonine protein kinases. This protein plays a role in regulating the MAP kinase/ERK signaling pathway, which affects cell division, differentiation, and secretion. Mutations in this gene, most commonly the V600E mutation, are the most frequently identified cancer-causing mutations in melanoma, and have been identified in various other cancers as well, including non-Hodgkin lymphoma, colorectal cancer, thyroid carcinoma, non-small cell lung carcinoma, hairy cell leukemia and adenocarcinoma of lung. In addition to V600E mutation, other mutations observed at the V600 position are V600D, V600K and V600R. Research has shown that patients with BRAF gene mutations are less effective in receiving EGFR-TKI drug therapy. Moreover, BRAF V600E mutation can make some KRAS wild-type patients insensitive to EGFR-TKI drug treatment. Therefore, the mutation detection of BRAF is very meaningful for the treatment of cancer.

[Test Principles]

UltraDx BRAF V600E/D/R/K Mutations Detection Kit is based on amplification-refractory mutation system (ARMS) technology, also known as allele-specific polymerase chain reaction (ASPCR), which is a reliable method for detecting any mutation involving single base changes or small deletions. ARMS is based on the use of sequence-specific PCR primers that allow amplification of test DNA only when the target allele is contained within the sample and will not amplify the nontarget allele. Following an ARMS reaction the presence or absence of a PCR product is diagnostic for the presence or absence of the target allele.

[Advantages]
  • High sensitivity: Accurate detection of mutation as low as 10 copies/uL.
  • Strong Specificity: The specificity can be reached 100% by using PCR technology.
  • Easy operation: results in 90 mins.
  • Reliable: Internal and External controls are included.
[Acceptable Specimens]

Applicable sample type: FFPE tumor tissue

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[Applicable Equipment]

Applied Biosystems™ Real time PCR system 7500, ABI QuantStudio™5 Real-time PCR system, LightCycler® 480 PCR system, Bio-Rad CFX96 real-time PCR instrument. Ultrassay eQ9600 Real Time qPCR System etc.