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5% PIK3CA E545K FFPE DNA Reference Standard

CatalogNo. specification
IB-GW-OPSS229 1 curl / tube
  • Intro
FFPE is a way of preserving and preparing biopsy samples to facilitate experimental research and diagnostic procedures/ pharmaceutical development.     
5% PIK3CA E545K FFPE DNA Reference Standard is a highly-characterized, biologically-relevant quality control material used to assess the performance of assays that detect somatic mutations.    
It covers lung cancer-related mutations of PIK3CA E545K validated by ddPCR. The FFPE format product allows you to evaluate and optimize DNA extraction protocols without wasting precious patient samples. With the Formalin-Compromised format, the robustness of your NGS workflow may be tested to ensure that your library protocol and informatics pipeline can accommodate these highly degraded samples. 
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存储温度 2-8˚C
保质期 48 months
规格 1 piece / tube

Authenticated Mutation

Test Test Method Acceptance Criteria
Allele Frequency (AF) and Genotype Droplet Digital PCR AF = 0, accepted range =≤0.1%; AF ＜1%, accepted range = ± 40%; 1% ≤AF≤5%, accepted range = ± 30%; 5% ＜ AF≤20%, accepted range = ± 20%; 20% ＜ AF, accepted range = ± 10%; Copy Numbern＜5, accepted range = ± 40%; 5≤Copy Number ＜10, accepted range = ± 30%; 10≤Copy Number, accepted range = ± 20%
Qualification Qubit dsDNA BR assay ≥400 ng/scroll (Maxwell? 16 FFPE plus LEV DNA Purification Kit (Promega))
Variant Type Mutation CDS Mutation Expected Allelic Frequency(%)/Copy Number COSMIC ID Chromosome Number Genomosome Position
SNV PIK3CA H1047R c.3140A＞G 5% COSM775 3 179234297
  • Evaluate of workflow integrity from pre-analytical DNA extraction to post-analytical bioinformatics
  • Gain certainty of the limit of detection and limit of quantification
  • Evaluate and optimize DNA extraction protocols or platform variablity
  • Assess the backgroud parameter effect with the testing
  • Assess the performance of detection workflow
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