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Onco Wildtype ctDNA Reference Standard

Product Code Specification
IB-GW-OCTM005 20ng/μL, 0.5μg/tube
  • Intro
Onco Wildtype ctDNA Reference Standard is a cell line derived, genomic identified quality control materials, which is matched with other GeneWell ctDNA reference standards as negative controls. Additionally, it can also be used to assess the overall performance of NGS panels to avoid false positive results. Benefits from the matched genomic background, this wildtype reference standard can also be used to dilute other GeneWell ctDNA standards to achieve lower allelic frequencies.
  • 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 0% COSM33765 14 104780214
2 SNV BRAF V600E c.1799T＞A 0% COSM476 7 140753336
3 SNV EGFR G719S c.2155G＞A 0% COSM6252 7 55174014
4 SNV EGFR L858R c.2573T＞G 0% COSM6224 7 55191822
5 SNV EGFR T790M c.2369C＞T 0% COSM6240 7 55181378
6 Insertion EGFR V769_D770insASV c.2307_2308insGCCAGCGTG 0% COSM12376 7 55181317-55181318
7 Deletion EGFR ΔE746_A750 c.2235_2249del15 0% COSM6223 7 55174772-55174786
8 SNV KRAS A146T c.436G＞A 0% COSM19404 12 25225628
9 SNV KRAS G12D c.35G＞A 0% COSM521 12 25245350
10 SNV KRAS G13D c.38G＞A 0% COSM532 12 25245347
11 SNV NRAS Q61K c.181C＞A 0% COSM580 1 114713909
12 SNV PIK3CA E545K c.1633G＞A 0% COSM763 3 179218303
13 SNV PIK3CA H1047R c.3140A＞G 0% COSM775 3 179234297
14 Fusion CD74-ROS1 fusion NA 0% COSF1200 6,5 117324415,150404680
15 Fusion EML4-ALK fusion V3 NA 0% COSF474 2,2 42264951,29223528
16 CNV ERBB2 Amplification NA 2 copies NA 17 39687914-39730426
17 CNV MET Amplification NA 2 copies NA 7 116672196-116798386
  • As a negative control of Onco SNV ctDNA Reference Standard
  • Other allele mutation frequencies were obtained by mixing with Onco SNV ctDNA Reference Standard
  • In combination with the use of Onco SNV ctDNA series Reference Standard, different mutation frequency gradients are set to verify the accuracy of the process
IB-GW-OCTM005-Package Insert： download
ctDNA-Flyer： download
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