Onco Fusion Multiplex FFPE(DNA/RNA) Reference Standard

CatalogNo. specification
IB-GW-RPSM1006 1 curl/tube
  • Intro
The product is a full-process reference material formulated for use with targeted Next Generation Sequencing (NGS) assays that detect somatic mutations in human cancer patient samples. The Onco Fusion Multiplex FFPE(DNA/RNA) Reference Standard is intended as a quality reference material for translational and disease research testing to monitor DNA extraction, library preparation, sequencing, and variant allele detection under a given set of bioinformatics pipeline parameters. For Research Use only. Not for use in diagnostic procedures.
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  • Application fields
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Validity 48 months
Storage 2-8℃
SPEC 1 curl/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 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
  • 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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