Human EGFR Gene 29 Mutations Detection Kit (Fluorescence PCR)-RUO

Short Description:

[Product Code] HWTS- TM4008

Short Description

This kit is used to in vitro qualitatively detection of common mutations in exons 18-21 of the EGFR gene in samples from human non-small cell lung cancer patients (see Table 1 for details).

Research Use Only


Product Detail

Product Tags

Product name

Human EGFR Gene 29 Mutations Detection Kit (Fluorescence PCR)-RUO

Epidemiology

Lung cancer has become the leading cause of cancer deaths worldwide, seriously threatening human health. Non-small cell lung cancer accounts for about 80%-85% of lung cancer patients. EGFR is currently the most important molecular target for the treatment of non-small cell lung cancer. The phosphorylation of EGFR can promote tumor cell growth, differentiation, invasion, metastasis, anti-apoptosis, and promote tumor angiogenesis. EGFR tyrosine kinase inhibitors (TKI) can block the EGFR signaling pathway by inhibiting EGFR autophosphorylation, thereby inhibiting the proliferation and differentiation of tumor cells, promoting tumor cell apoptosis, reducing tumor angiogenesis, etc., so as to achieve tumor targeted therapy [1]. A large number of studies have shown that the therapeutic efficacy of EGFR-TKI is closely related to the status of EGFR gene mutation, and can specifically inhibit the growth of tumor cells with EGFR gene mutation [2,3]. The EGFR gene is located on the short arm of chromosome 7 (7p12), with a full length of 200Kb and consists of 28 exons. The mutation region is mainly located in exons 18 to 21, codons 746 to 753 deletion mutation on exon 19 accounts for about 45% and the L858R mutation on exon 21 accounts for about 40% to 45% [4]. The NCCN Guidelines for the Diagnosis and Treatment of Non-Small Cell Lung Cancer clearly states that EGFR gene mutation testing is required before EGFR-TKI administration. This test kit is used to guide the administration of epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) drugs, and provide the basis for personalized medicine for patients with non-small cell lung cancer. This kit is only used for the detection of common mutations in the EGFR gene in patients with non-small cell lung cancer. The test results are for clinical reference only and should not be used as the sole basis for individualized treatment of patients. Clinicians should consider the patient's condition, drug indications, and treatment.The reaction and other laboratory test indicators and other factors are used to comprehensively judge the test results.

Channel

Reaction Buffer Channel
EGFR IC Reaction Buffer FAM channel
L858R Reaction Buffer FAM channel
19del Reaction Buffer FAM channel
T790M Reaction Buffer FAM channel
G719X Reaction Buffer FAM channel
3Ins20 Reaction Buffer FAM channel
L861Q Reaction Buffer FAM channel
S768I Reaction Buffer FAM channel

Technical Parameters

Storage Liquid: ≤ -18℃ In dark
Shelf-life 12 months
Specimen Type fresh tumor tissue, frozen pathological section, paraffin-embedded pathological tissue or section , plasma or serum
CV <5.0%
LoD nucleic acid reaction solution detection under the background of 3ng/μL wild-type, can stably detect 1% mutation rate;

b) nucleic acid reaction Under the 1% mutation rate, 1×103Copies/mL mutation can be stably detected in the wild-type background of 1×105Copies/mL;

c) The internal reference reaction solution can detect the reference product SW3 with the lowest detection limit of the enterprise internal reference. When the kit detects the national detection limit reference material, the 2.5% mutation frequency detection limit reference material and the EGFR gene amplification mutation with a copy number variation of 4 can be stably detected.

Specificity There is no cross-reactivity with wild-type human genomic DNA and other mutant types
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

Human EGFR Gene 29 Mutations Detection Kit (Fluorescence PCR)-RUO (2)

 

Reagents required but not provided: DNase/RNase Free Water, anhydrous ethanol. When testing a paraffin-embedded tissue sample, it is recommended to use QIAamp DNA FFPE Tissue Kit (56404) by QIAGEN and Paraffin-embedded Tissue DNA Rapid Extraction Kit (DP330) by Tiangen Biotech (Beijing) Co., Ltd.. When testing plasma/serum sample, it is recommended to use Macro & Micro-Test General DNA/RNA Kit (HWTS-3019-50, HWTS-3019-32, HWTS-3019-48, HWTS-3019-96) (which can be used with Macro & Micro-Test Automatic Nucleic Acid Extractor (HWTS-3006C, HWTS-3006B)) by Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. or QIAamp Circulating Nucleic Acid Kit (55114) by QIAGEN.

Consumables required but not provided: DNase/RNase Free Tips, disposable gloves, DNase/RNase Free Centrifuge tube, 8-tube strips for PCR, centrifuge.


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