Onco SNV Multiplex 5% FFPE Reference Standard

Product Code Specification
IB-GW-OPSM003 1 FFPE section/tube
  • Intro
Onco SNV multiplex 5% FFPE reference standard is a full process quality control material, covering 8 cancer-related single nucleotide variants at 5% allelic frequency. It is a cell line derived reference standard and compatible with multiple platforms including NGS and PCR, providing reliable references from sample extraction to bioinformatic analysis.
  • Product information
  • Application fields
  • Resources
规格 2-8℃
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 EGFR L858R c.2573T>G 5% COSM6224 7 55191822
2 SNV EGFR T790M c.2369C>T 5% COSM6240 7 55181378
3 Deletion EGFR ΔE746_A750 c.2235_2249del15 5% COSM6223 7 55174772-55174786
4 SNV KRAS A146T c.436G>A 5% COSM19404 12 25225628
5 SNV KRAS G12D c.35G>A 5% COSM521 12 25245350
6 SNV KRAS G13D c.38G>A 5% COSM532 12 25245347
7 SNV NRAS Q61K c.181C>A 5% COSM580 1 114713909
8 SNV PIK3CA E545K c.1633G>A 5% COSM763 3 179218303
  • 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
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IB-GW-OPSM003-Package Insert: download