|Product Description:||CD Tumor Fusion Multilocus FFPE (DNA/RNA) Standards contains multiple fusion gene types and containing fusion at both DNA and RNA levels, prepared by cell mixing.
The product contains ALK, RET, ROS1, MET, NTRK1/3 and FGFR2/3, which are the representative fusion loci recommended by NCCN and CSCO guidelines and the consensus of domestic cancer molecular testing experts for concomitant diagnosis and efficacy prediction of the top 10 most prevalent cancers in the world, and the fusion mutations are all translocations, which can meet the dual needs of DNA/RNA detection.
(1)Fusion gene DNA mutation frequency is tesed by Droplet Digital PCR, the acceptance criteria as follows：
AF=0%, acceptable range ≤0.1%
0＜AF＜1%, acceptable error range = ±40%
1% ≤ AF <5%, acceptable error range = ±30%
5% ≤ AF ≤ 20%, acceptable margin of error = ± 20%
Copy number variation <5, acceptable error range = ±40%
5 ≤ copy number variation <10, acceptable error range = ±30%
Copy number variation ≥10, acceptable error range = ±20%
(2)Fusion gene RNA expression is tesed by End-Point RT-PCR.
Slice thickness: 10μm/roll
Fusion genes：EML4(13)-ALK(20), SLC34A2(4)-ROS1(32&34), TPM3(7)-NTRK1(10), FGFR2(17)-COL14A1(34), FGFR3(17)-TACC3(4), CCDC6(1)-RET(12), MET Exon 14 Skipping, ETV6(5)-NTRK3(15)
|Method:||Quality Control Method: ddPCR|
|Concentration:||DNA extraction amount ≥200 ng/volume
RNA extraction amount≥100 ng/volume
|Application:||CD Tumor Fusion Multilocus FFPE (DNA/RNA) Standards is validated by ddPCR and has a stable content, which can assist testing organizations in quality control of the whole process starting from sample extraction. It is suitable for PCR and NGS assay platforms, and can be applied to IVD kits/LDT process performance validation and daily quality control.|
|Storage:||Store at 2-8℃, 18 months.|