Onco Structural Multiplex 5% ctDNA Reference Standard
| Product Code | Specification |
|---|---|
| IB-GW-OCTM001 | 20ng/μL, 0.5μg/tube |
| Product Code | Specification |
|---|---|
| IB-GW-OCTM001 | 20ng/μL, 0.5μg/tube |
| 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 | 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 | NA | 17 | 39687914-39730426 |
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