|Product Description:||Compared with tissue testing, liquid biopsy is convenient, rapid, immediate, inexpensive and minimally invasive, which makes it rapidly become a popular research for tumor genetic testing or even early tumor screening at present. However, due to the limitations of a series of factors such as small DNA fragments, short half-life, low abundance, gradual decrease in content during tumor treatment, normal cell DNA contamination, and different detection methods, there is no uniform standard for the accuracy of results.
This standard highly simulates clinical samples and contains 8 ddPCR-validated copy number variants/amplifications, translocations and large fragment insertions/deletions, and high/low GC intra-regional variants that can be used to validate your molecular and bioinformatics processes.
(1)Allele Frequency (AF) Genotype is tesed by Droplet Digital PCR, the acceptance criteria as follows：
AF=0%, acceptable range ≤0.1%
AF <1%, acceptable error range = ±50% (the AF value detected at the 0.1% locus must be at least 0.05% higher than the corresponding wild-type locus)
1% ≤ AF <5%, acceptable error range = ±40%
5% ≤ AF < 10%, acceptable margin of error = ± 30%
10% ≤ AF, acceptable margin of error = ±20%
Copy number <5, acceptable error range = ±40%
5 ≤ copy number <10, acceptable error range = ±30%.
(2)Fragment distribution is tesed by 4150 TapeStation System, the average fragment length 160bp±10%.
SNV: AKT1 E17K, PIK3CA E545Km.
Deletion: EGFR ΔE746_A750.
Fusion: CD74(6)-ROS1(34), EML4(6)-ALK(20).
CNV: MET Amplification, CNV MET Amplification.
|Method:||Quality Control Method: ddPCR|
|Application:||CD Tumor Structural Variation 5% ctDNA Standard is suitable for all processes of liquid biopsy: from library preparation, variant detection, to information analysis; and also for all assays: NGS sequencing, PCR detection, etc.|
|Preservation Solvent:||Tris-EDTA (10mM Tris-HCl, 1mM EDTA), pH 8.0|
|Storage:||Store at 2-8℃, 24 months.|