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Onco SNV Multiplex 5% FFPE Reference Standard

CatalogNo. specification
IB-GW-OPSM003 1 curl / tube
  • Intro
FFPE is a way of preserving and preparing biopsy samples to facilitate experimental research and diagnostic procedures/ pharmaceutical development.      
Onco SNV Multiplex 5% FFPE  Reference Standard is a highly-characterized, biologically-relevant quality control material used to assess the performance of NGS assays that detect somatic mutations.     
It covers 7 SNV mutations and 1 deletion 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))
Number Variant Type Mutation CDS Mutation Expected Allelic Frequency(%)/Copy Number COSMIC ID Chromosome Number Genomosome Position
1 SNV EGFR L858R c.2573T＞G 5% COSM6224 7 55191822
2 SNV EGFR T790M c.2369C＞T 5% COSM6240 7 55181378
3 Deletion EGFR ΔE746_A750 c.2235_2249del15 5% COSM6223 7 55174772-55174786
4 SNV KRAS A146T c.436G＞A 5% COSM19404 12 25225628
5 SNV KRAS G12D c.35G＞A 5% COSM521 12 25245350
6 SNV KRAS G13D c.38G＞A 5% COSM532 12 25245347
7 SNV NRAS Q61K c.181C＞A 5% COSM580 1 114713909
8 SNV PIK3CA E545K c.1633G＞A 5% COSM763 3 179218303
  • 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
COA-GW-OPSM003-201906001： download
产品说明书及附件-GW-OPSM003-201906001： download
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