EGFR Multiplex cfDNA Reference Standard Set

EGFR Multiplex cfDNA Reference Standard Set

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    商品描述
    The EGFR Multiplex cfDNA Reference Standard Set is a cell line-derived, clinically relevant control that can be used to assess the performance of cfDNA assays that detect somatic resistance mutations in EGFR.
    组成成分
    EGFR Multiplex脱氧核糖核酸<1%,水>99%,Tris-EDTA缓冲液(三羟甲基氨基甲烷,乙二胺四乙酸)<1%

    High-throughput platforms such as PCR-based assays and Next Generation Sequencing (NGS) give laboratories much greater power when profiling cfDNA samples. However, small quantities of DNA in combination with complex variants at low allelic frequencies represents one of the major challenges users encounter when profiling cfDNA. Horizon Discovery has developed a comprehensive cfDNA Reference Standard range to support the development and continued validation of cfDNA assays. Our cfDNA products are derived from human cell lines and fragmented to an average size of 160 bp to closely resemble cfDNA extracted from human plasma. The EGFR Multiplex cfDNA Reference Standard is supplied at 5%, 1%, 0.1% and 0% (EGFR Multiplex wild type) allelic frequencies and covers ten EGFR variants implicated in the responsiveness to EGFR tyrosine kinase inhibitors (EGFR-TKIs) and anti-EGFR monoclonal antibodies. This product covers clinically relevant SNPs, insertions and deletions in EGFR and can be used to optimize, validate or routinely monitor assay performance.

    With this product, you are able to:

    • Analyze the sensitivity and specificity of your assay
    • Gain certainty of the limit of detection and limit of quantification
    • Optimize and validate new EGFR-specific assays and routinely monitor their performance 

    Technical Data

    Format: cfDNA

    Genes Covered: EGFR

    Allelic Frequencies: 5%, 1%, 0.1% and 0% (EGFR Multiplex wild type)

    Buffer: Tris-EDTA (10mM Tris-HCl, 1mM EDTA), pH 8.0

     

    Product Information

    Fragment Size: 160 bp

    Unit Size: 350 ng per vial

    Concentration: 20 ng/µl

    Verified Mutations:

    EGFR Multiplex wild type cfDNA Reference Standard: HD824

    Chromosome

    Gene

    Variant

    Expected Allelic Frequency

    7p12

    EGFR

    L858R

    0.0%

    7p12

    EGFR

    ΔE746 - A750

    0.0%

    7p12

    EGFR

    T790M

    0.0%

    7p12

    EGFR

    V769 - D770insASV

    0.0%

    7p12

    EGFR

    L861Q

    0.0%

    7p12

    EGFR

    G719S

    0.0%

    7p12

    EGFR

    C797S

    0.0%

    7p12

    EGFR

    S464L

    0.0%

    7p12

    EGFR

    G465R

    0.0%

    7p12

    EGFR

    S768I

    0.0%

    5% EGFR Multiplex cfDNA Reference Standard: HD821

    Chromosome

    Gene

    Variant

    Expected Allelic Frequency

    7p12

    EGFR

    L858R

    5.0%

    7p12

    EGFR

    ΔE746 - A750

    5.0%

    7p12

    EGFR

    T790M

    5.0%

    7p12

    EGFR

    V769 - D770insASV

    5.0%

    7p12

    EGFR

    L861Q

    5.0%

    7p12

    EGFR

    G719S

    5.0%

    7p12

    EGFR

    C797S

    5.0%

    7p12

    EGFR

    S464L

    5.0%

    7p12

    EGFR

    G465R

    5.0%

    7p12

    EGFR

    S768I

    5.0%

    1% EGFR Multiplex cfDNA Reference Standard: HD822

    Chromosome

    Gene

    Variant

    Expected Allelic Frequency

    7p12

    EGFR

    L858R

    1.0%

    7p12

    EGFR

    ΔE746 - A750

    1.0%

    7p12

    EGFR

    T790M

    1.0%

    7p12

    EGFR

    V769 - D770insASV

    1.0%

    7p12

    EGFR

    L861Q

    1.0%

    7p12

    EGFR

    G719S

    1.0%

    7p12

    EGFR

    C797S

    1.0%

    7p12

    EGFR

    S464L

    1.0%

    7p12

    EGFR

    G465R

    1.0%

    7p12

    EGFR

    S768I

    1.0%

    0.1% EGFR Multiplex cfDNA Reference Standard: HD823

    Chromosome

    Gene

    Variant

    Expected Allelic Frequency

    7p12

    EGFR

    L858R

    0.1%

    7p12

    EGFR

    ΔE746 - A750

    0.1%

    7p12

    EGFR

    T790M

    0.1%

    7p12

    EGFR

    V769 - D770insASV

    0.1%

    7p12

    EGFR

    L861Q

    0.1%

    7p12

    EGFR

    G719S

    0.1%

    7p12

    EGFR

    C797S

    0.1%

    7p12

    EGFR

    S464L

    0.1%

    7p12

    EGFR

    G465R

    0.1%

    7p12

    EGFR

    S768I

    0.1%

    An additional EGFR mutation is detectable in this reference standard. The allelic frequency of the mutation is not reported on the Certificate of Analysis. We include the details here to allow our customers to assess any impact on their work flows when using this product.

    AA MutationCDS mutationGRCh67 LocationrsIDCause
    Q787Qc.2361G>A7:55249063rs1050171Endogenous variant

     

    General Information

    Storage: 4°C

    Expiry: See all product shelf life information

     

    Quality Control

    Fragmentation Size: D1000 DNA Screen Tape assay

    Allelic Frequency: Droplet Digital™ PCR

    Quantification: Qubit dsDNA BR Assay (post-fragmentation)

    Intended use: For assay developers and molecular diagnostic labs for routine performance monitoring of molecular biology assays. Research use only. Not for diagnostic procedures.

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    货号:
    HD825
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