Quality Standards
(1)Allele Frequency (AF) Genotype is tesed by Droplet Digital PCR, the acceptance criteria as follows:
AF=0%, acceptable range ≤ 0.1%;
AF < 5%, acceptable margin of error = ± 30%;
5% ≤ AF < 10%, acceptable margin of error = ± 20%;
10%≤AF, acceptable error range = ±10%.
(2)Integrity is tesed by Agarose gel electrophoresis, the acceptance criteria as follows:
Bright band of high molecular weight.
SNV: AKT1 E17K,BRAF V600E,EGFR G719S,EGFR L858R,EGFR T790M, KIT D816V,KRAS A146T, KRAS G12D,KRAS G13D,NRAS Q61K, PIK3CA E545K,PIK3CA H1047R,KRAS G12C,KRAS G12V,EGFR L861Q,EGFR S768I, KRAS G12S, KRAS G12R,KRAS G12A,EGFR G719A,NRAS Q61R,FGFR3 Y375C.
Deletion: EGFR ΔE746_A750,FLT3 ΔI836,MET Exon 14 Skipping.
Insertion: EGFR A767_V769dup.
Fusion: CD74(6)-ROS1(34),EML4(6)-ALK(20), EML4(13)-ALK(20).
CNV: MET Amplification, ERBB2 Amplification.
| Method: | Quality Control Method: ddPCR |
| Concentration: | 30 ng/µL |
| Application: | CD Tumor SNV Wild Type gDNA Standard is mainly used as a negative control for gDNA variant detection during second-generation sequencing. It can be used in combination with Tumor Structure Variant 5% gDNA Standard and Tumor SNV 5% gDNA Standard. |
| Preservation Solvent: | Tris-EDTA (10mM Tris-HCl, 1mM EDTA), pH 8.0 |
| Storage: | Store at 2-8℃, 36 months. |
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