Onco Fusion Multiplex FFPE(DNA/RNA) Reference Standard

Product Code Specification
IB-GW-RPSM1006 1 FFPE section/tube
  • Intro
Onco fusion multiplex (DNA/RNA) FFPE reference standard is a full-process quality control material, which includes DNA variants and RNA expression of distinct fusions in a single FFPE block. It is compatible with NGS and PCR-based platforms to monitor the efficiency and performance of DNA extraction, library preparation, sequencing, and bioinformatic analysis processes. In addition, the highly multiplex formats also further convenience the usage and reduce the QC costs by customers.
  • Product information
  • Application fields
  • Resources
Related Diseases NSCLC, breast cancers, colorectal cancer, etc.
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
  • 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
IB-GW-RPSM1006-Package Insert: download
FFPE-Flyer: download