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Onco Structural Multiplex 5% FFPE Reference Standard

CatalogNo. specification
IB-GW-OPSM002 1 curl/tube
  • Intro
FFPE is a way of preserving and preparing biopsy samples to facilitate experimental research and diagnostic procedures/ pharmaceutical development.       
Onco Structural Multiplex 5% FFPE Reference Standard is a highly-characterized, biologically-relevant quality control material, which can be used to assess the performance of NGS assays that detect structural, low-allelic somatic mutations.      
It covers a wide range of mutations in defined genomic context.  Additionally, you may examine the genomic context of variants within regions of specific GC-content (high vs. low). Onco Structural Multiplex 5% FFPE Reference Standard includes 8 digital PCR-validated copy number variants/amplifications, translocations, and large insertions/deletions.
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存储温度 2-8℃
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 AKT1 E17K c.49G＞A 5% COSM33765 14 104780214
2 SNV PIK3CA E545K c.1633G＞A 5% COSM763 3 179218303
3 Insertion EGFR V769_D770insASV c.2307_2308insGCCAGCGTG 5% COSM12376 7 55181317-55181318
4 Deletion EGFR ΔE746_A750 c.2235_2249del15 5% COSM6223 7 55174772-55174786
5 Fusion CD74-ROS1 Fusion NA 5% COSF1200 6,5 117324415,150404680
6 Fusion EML4-ALK Fusion V3 NA 5% COSF474 2,2 42264951,29223528
7 CNV MET Amplification NA 3.5 copies NA 7 116672196-116798386
8 CNV ERBB2 Amplification NA 7.0 copies MA 17 39687914-39730426
  • 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-OPSM002-201907001： download
产品说明书及附件-GW-OPSM002-201907001： download
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