|Product Description:||CD Pan-Tumor 800 gDNA Standards cover 450 COSMIC mutation loci, including gene SNV, fusions, copy number variants (CNV) and base insertion deletions and other common variants in the cancer genome, with mutation site frequencies ranging from 1% to 100%, of which 52 mutation sites are under ≤20% AF and can be used for detection limit quality control of the kit.|
(1)Allele Frequency (AF) Genotype is tesed by Droplet Digital PCR, the acceptance criteria as follows：
AF = 0%, accepted range =≤0.1%;
AF ＜5%, accepted range =± 30%;
5% ≤AF ＜ 10%, accepted range = ± 20%;
10% ≤AF, accepted range = ± 10%;
Copy Number＜ 5, accepted range =± 30%;
5 ≤ Copy Number ＜10, accepted range = ± 20%;
10 ≤ Copy Number, accepted range = ± 10%.
(2)Integrity is tesed by Agarose gel electrophoresis, the acceptance criteria as follows：
Bright band of high molecular weight.
SNV: EGFR L858R,KRAS A146T, NRAS Q61K, EGFR T790M, KIT D816V, KRAS G12D, EGFR G719S, KRAS G13D, BRAF V600E, PIK3CA H1047R.
Deletion: EGFR ΔE746_A750, FLT3 ΔI836.
Insertion: EGFR A767_V769dup.
CNV: ERBB2 Amplification.
|Method:||Quality Control Method: ddPCR and 500X WES|
|Application:||CD Pan-Tumor gDNA standards can be used to:
•Tumor Companion Diagnostic Panel: Accuracy Validation, Repeatability Detection, Robust Validation, Limits of detection (LODs) , Comparison of Genotype Detecting Perfomance.
•Comparison of WES Process.
•Consistency Comparison of WES and Panel.
|Preservation Solvent:||Tris-EDTA (10mM Tris-HCl, 1mM EDTA), pH 8.0.|
|Storage:||Store at 2-8℃, 36 months.|