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Onco Wildtype FFPE Reference Standard

CatalogNo. specification
IB-GW-OPSM005 1 curl / tube
  • Intro
FFPE is a way of preserving and preparing biopsy samples to facilitate experimental research and diagnostic procedures/ pharmaceutical development.       
Onco Wildtype FFPE Reference Standard is mainly used as negative controls used to assess the performance of assays that detect somatic mutations, such as NGS and qPCR etc. It matches Onco Structural Multiplex 5% FFPE Reference Standard and Onco SNV Multiplex 5% FFPE  Reference Standard etc. to evaluate specificity and sensitivity of assays.
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存储温度 2-8℃
保质期 48 months
规格 1 piece / tube

Authenticated Mutation

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 0% COSM33765 14 104780214
2 Insertion EGFR V769_D770insASV c.2307_2308insGCCAGCGTG 0% COSM12376 7 55181317-55181318
3 Deletion EGFR ΔE746_A750 c.2235_2249del15 0% COSM6223 7 55174772-55174786
4 SNV EGFR L858R c.2573T＞G 0% COSM6224 7 55191822
5 SNV EGFR T790M c.2369C＞T 0% COSM6240 7 55181378
6 SNV KRAS G12D c.35G＞A 0% COSM521 12 25245350
7 SNV KRAS G13D c.38G＞A 0% COSM532 12 25245347
8 SNV KRAS A146T c.436G＞A 0% COSM19404 12 25225628
9 SNV NRAS Q61K c.181C＞A 0% COSM580 1 114713909
10 SNV PIK3CA E545K c.1633G＞A 0% COSM763 3 179218303
11 Fusion CD74-ROS1 Fusion NA 0% COSF1200 6,5 117324415,150404680
12 Fusion EML4-ALK Fusion V3 NA 0% COSF474 2,2 42264951,29223528
13 CNV MET Amplification NA 2 copies NA 7 116672196-116798386
14 CNV ERBB2 Amplification NA 2 copies NA 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
COA-GW-OPSM005-201906001： download
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