Onco Fusion Multiplex FFPE(DNA/RNA) Reference Standard
Product Code | Specification |
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IB-GW-RPSM1006 | 1 FFPE section/tube |
Product Code | Specification |
---|---|
IB-GW-RPSM1006 | 1 FFPE section/tube |
Related Diseases | NSCLC, breast cancers, colorectal cancer, etc. |
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Specification | 1-2 FFPE section/tube |
Storage Condition | 2-8˚C |
Shelf Life | 24 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 | Fusion | COSMIC ID | Fusion information(GRCh38 · COSMICv96) | Expected AF(DNA) | Expression (RNA) |
---|---|---|---|---|---|
1 | EML4(13)-ALK(20) | COSF408 | ENST00000318522.9(EML4):r.1_1751_ENST00000389048.7(ALK):r.4080_6220 | 4%-7% | Detection |
2 | SLC34A2(4)-ROS1(32&34) | COSF1196 | ENST00000382051.7(SLC34A2):r.1_429_ENST00000368508.7(ROS1):r.5448_7435 | 4%-7% | Detection |
3 | TPM3(7)-NTRK1(10) | COSF1329 | ENST00000368533.7(TPM3):r.1_717::ENST00000392302.6(NTRK1):r.1262_2609 | 6%~10% | Detection |
4 | ETV6(5)-NTRK3(15) | COSF571 | ENST00000396373.8(ETV6):r.1_1283::ENST00000394480.6(NTRK3):r.1908_19984 | 10%~40% | Detection |
5 | FGFR2(17)-COL14A1(34) | // | ENST00000358487.10(FGFR2)17:121483698_COL14A1 exon34:120289608 | 16%~24% | Detection |
6 | FGFR3(17)-TACC3(4) | // | ENST00000440486.8(FGFR3)17: 1807033_ ENST00000313288.9(TACC3)4:1727832 | 5%~9% | Detection |
7 | CCDC6(1)-RET(12) | COSF1271 | ENST00000263102.6(CCDC6):r.1_535::ENST00000355710.7(RET):r.2369_5659 | 8%~13% | Detection |
8 | MET Exon 14 Skipping | COSM13245 | c.2942_3082del (Deletion) | 12%~20% | Detection |