KRAS 8 Mutations Detection Kit (Fluorescence PCR)-RUO

Short Description:

[Product Code] HWTS-TM4009

Short Description

This kit is intended for in vitro qualitative detection of 8 mutations in codons 12 and 13 of K-ras gene in extracted DNA from human paraffin-embedded pathological sections.

Research Use Only


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Product name

KRAS 8 Mutations Detection Kit (Fluorescence PCR)-RUO

Epidemiology

Point mutations in the KRAS gene have been found in a number of human tumor types, about 17%~25% mutation rate in tumor, 15%~30% mutation rate in lung cancer patients, 20%~50% mutation rate in colorectal cancer patients. Because the P21 protein encoded by the K-ras gene is located downstream of the EGFR signaling pathway, after the K-ras gene mutation, the downstream signaling pathway is always activated and is not affected by the upstream targeted drugs on EGFR, resulting in continuous malignant proliferation of cells. Mutations in the K-ras gene generally confer resistance to EGFR tyrosine kinase inhibitors in lung cancer patients and resistance to anti-EGFR antibody drugs in colorectal cancer patients [1, 2, 3]. In 2008, the National Comprehensive Cancer Network (NCCN) issued a clinical practice guideline for colorectal cancer, which pointed out that the mutation sites that cause K-ras to be activated are mainly located in codons 12 and 13 of exon 2, and recommended that all patients with advanced metastatic colorectal cancer can be tested for K-ras mutation before treatment[4]. Therefore, rapid and accurate detection of K-ras gene mutation is of great significance in clinical medication guidance. This kit uses DNA as the detection sample to provide qualitative assessment of mutation status, which can assist clinicians in screening colorectal cancer, lung cancer and other tumor patients who benefit from targeted drugs. The test results of the kit are for clinical reference only and should not be used as the sole basis for individualized treatment of patients. Clinicians should make comprehensive judgments on the test results based on factors such as the patient's condition, drug indications, treatment response and other laboratory test indicators.

Technical Parameters

Storage  ≤-18℃
Shelf-life  12 months
Specimen Type human paraffin-embedded pathological sections
CV ≤5.0%
LoD a) K-ras Reaction Buffer A and K-ras Reaction Buffer B can stably detect 1% mutation rate under 3ng/μL wild-type background; b) A mutation of 1×103Copies/mL can be stably detected in a wild-type background of 1×105Copies/mL when the mutation rate is 1%; c) When the company LoD reference SW3 is tested, there is no Ct value or Ct value=0 of Reaction Buffer A and Reaction Buffer B
Applicable Instruments Applied Biosystems 7500 Real-Time PCR Systems, Applied Biosystems 7300 Real-Time PCR Systems, QuantStudio®5 Real-Time PCR Systems, LightCycler® 480 Real-Time PCR system, BioRad CFX96 Real-Time PCR System. 

 

Work Flow

Reagent required but not provided:DNase/RNase free H2O, anhydrous ethanol. When testing a paraffin-embedded tissue sample, it is recommended to use QIAGEN's QIAamp DNA FFPE Tissue Kit (56404) and Paraffin-embedded Tissue DNA Rapid Extraction Kit (DP330) manufactured by Tiangen Biotech(Beijing) Co., Ltd.

Consumables required but not provided: DNase/RNase free tips, disposable gloves, DNase/RNase free Centrifuge tube, 8-tube strips, centrifuge.


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