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Onco Structural Multiplex 5% gDNA Reference Standard

Product Code Specification
IB-GW-OGTM001 30ng/µL, 1µg/Tube
  • Intro
Onco Structural Multiplex 5% gDNA Reference Standard is a highly characterised, biologically relevant quality control material to support the development, validation and routine QC of companion diagnostics assays on NGS and PCR-based platforms. It covers 8 variants at 5% allelic frequency, including SNPs, insertions and deletions, which can contribute to the validation of sensitivity and specificity, verification of limit of detection and limit of quantification, and development of new cancer panels.
  • Product information
  • Application fields
  • Resources
Related Diseases NSCLC，breast cancers，colorectal cancer, etc.
Buffer Tris-EDTA (10mM Tris-HCl, 1mM EDTA), pH 8.0
Specification 30ng/µL, 1µg/tube
Storage Condition 2-8˚C
Shelf Life 36 months
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- Package Insert： download
IB-GW-OGTM001-Flyer： download
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