Onco Structural Multiplex 5% ctDNA Reference Standard

Product Code Specification
IB-GW-OCTM001 20ng/μL, 0.5μg/tube
  • Intro
Onco structural multiplex 5% ctDNA reference standard is derived from human cell lines and fragmented to mimic clinical samples. It covers a wide range of precisely verified variants in a defined genomic context, designated to valid the performance of NGS and PCR assays in detecting various types of mutations in low allelic frequencies, including SNV, insertion, deletion and copy number variants. Additionally, it can also be used to verify the variants within regions of specific GC-content in a complex genomic background.
  • Product information
  • Application fields
  • Resources
Product Format ctDNA
Fragment Size ~160bp
Description Three tubes set containing the same variants with 0.1%, 1%, and 0% AFs
Buffer Tris-EDTA (10mM Tris-HCl, 1mM EDTA), pH 8.0
Specification 20ng/μL, 0.5μg/tube
Storage Condition 2-8℃
Shelf Life 36 months
Test Test Method Acceptance Criteria
Allele Frequency (AF) and Genotype Droplet Digital PCR AF = 0%, accepted range = ≤0.1%; AF <1%, accepted range = ± 50% (0.1% AF = ≥0.05% + wildtype ); 1% ≤AF < 5%, accepted range =± 40%; 5% ≤AF < 10%, accepted range = ± 30%; 10% ≤AF, accepted range = ± 20%; Copy Number< 5, accepted range = ± 40%; 5 ≤ Copy Number <10, accepted range = ± 30%
Fragmentation Size D1000 DNA ScreenTape assay 160bp±10%
Quantification Qubit dsDNA BR assay 17-23 ng/μl
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
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  • 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
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