Onco Structural Multiplex 5% gDNA Reference Standard

CatalogNo. specification inventory
IB-GW-OGTM001 1µg/Tube 9999
  • Intro
Next generation sequencing (NGS) platforms give researchers much greater power when profiling the complex human genome. However, the use of NGS presents challenges surrounding sample variability, platform bias, and potential failure to detect biomarkers.            
Genewell’s standards are appropriate for any NGS library preparation including whole-genome, whole-exome, custom capture and targeted amplicon panels.           
Onco Structural Multiplex 5% gDNA Reference Standard is a highly characterized, biologically relevant quality control materials to support the development and continued validation of Next Generation Sequencing platforms. Onco Structural Multiplex 5% gDNA reference standard covers 8 mutations at 5% allelic frequency in genomic DNA format. The Reference Standard portfolio covers multiple endogenous SNPs, insertions and deletions. It may be diluted to even lower allelic frequencies using our Onco Wildtype standard.            
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 cancer panels and routinely monitor the performance of your assay.
  • Product information
  • Application fields
  • File download
浓度 30ng/µL
保存溶剂 Tris-EDTA (10mM Tris-HCl, 1mM EDTA), pH 8.0
存储温度 2-8˚C
保质期 36 months
规格 1µg/tube

Authenticated Mutation

Test Test Method Acceptance Criteria
Allele Frequency (AF) and Genotype Droplet Digital PCR AF = 0%, accepted range =≤0.1%; AF <5%, accepted range =± 30%; 5% ≤AF < 10%, accepted range = ± 20%; 10% ≤AF, accepted range = ± 10%; Copy Number< 5, accepted range =± 30%; 5 ≤ Copy Number <10, accepted range = ± 20%; 10 ≤ Copy Number, accepted range = ± 10%
Quality Agarose gel electrophoresis Bright band of high molecular weigh
Quantification Qubit? dsDNA BR Assay 30 ng/μL±10%
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 NA 17 39687914-39730426
  • Assess the performance of detection workflow
  • Assess the backgroud parameter effect with the testing
  • Validate the robustness of the bioinformatics process
  • Optimize and validate new cancer panels and routinely monitor the performance of your assay
  • Gain certainty of the limit of detection and limit of quantification
  • Analyze the sensitivity, accuracy, and specificity of your assay
  • Compare platform variability
IB-GW-OGTM001-product manual-20220601: download
IB-GW-OGTM001-product insert-20220601: download