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Quality Standards
(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.
SNV: AKT1 E17K,EGFR L858R,EGFR T790M, KRAS G12D,KRAS G13D,KRAS A146T, NRAS Q61K, PIK3CA E545K.
Deletion: EGFR ΔE746_A750,FLT3 ΔI836,MET Exon 14 Skipping.
Insertion: EGFR_A767_V769dup.
Fusion: CD74(6)-ROS1(34),EML4(6)-ALK(20).
CNV: MET Amplification, ERBB2 Amplification.
Method: | Quality Control Method: ddPCR |
Concentration: | DNA extraction amount ≥400 ng/volume |
Application: | CD Tumor Wild-Type FFPE Standard is mainly used as a negative control during the FFPE variant detection (sample/standard) assay, and can be used with tumor structural variant 5% FFPE standard and tumor SNV 5% FFPE standard. |
Storage: | Store at 2-8℃, 48 months. |
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