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Onco Wildtype FFPE Reference Standard

Product Code Specification
IB-GW-OPSM005 1 FFPE section/tube
  • Intro
Onco wildtype FFPE reference standard is a patient sample mimicking quality control material that verified to be wildtype in over 14 cancer-related hotspot variants. It can be used as a negative control for platform verification and run together with other GeneWell FFPE standards as a genomic matched wildtype.
  • 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 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
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FFPE-Flyer： download
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