Onco Structural Multiplex 5% FFPE Reference Standard

Product Code Specification
IB-GW-OPSM002 1 FFPE section/tube
  • Intro
Onco structural multiplex 5% FFPE reference standard is a highly-characterised and patient sample mimicking quality control material, which can be used to assess the performance of NGS and PCR-base assays detecting structural and somatic mutations at relatively low allelic frequencies. It covers 8 SNV and copies number variants in defined genomic context within regions of distinct GC content.
  • Product information
  • Application fields
  • Resources
Related Diseases NSCLC,breast cancers,colorectal cancer, etc.
Specification 1 FFPE section/tube
Storage Condition 2-8℃
Shelf Life 48 months
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
IB-GW-OPSM002- Package Insert: download
FFPE-Flyer: download