YY/T 1586-2018Individualized treatment tumor related gene mutation detection kit(Fluorescent PCR) (English PDF)

3.1 Appearance

The components of the kit should be complete and complete, and the liquid should be free of leakage.

3.2 Positive coincidence rate

Positive national reference products and/or standardized enterprise reference products within the scope of the test kit, the test results should be positive and consistent with the corresponding Variable type.

The setting of positive reference products should follow the following principles.

a) all types of mutations detectable within the scope of the kit;

b) 3 mutation percentage gradients for each mutation site, weak positive reference. no more than 3 times the detection limit mutation rate; medium positive Reference product. mutation rate is not higher than 40%; strong positive reference product. mutation rate is not less than 70%;

c) In the positive reference composition used, the matrix of the common mutation site reference should be the same or similar to the actual test sample matrix.

3.3 Negative compliance rate

Test negative national reference products and/or standardized enterprise reference products, the test results should be negative or wild type.

The setting of the negative reference should follow the following principles.

a) should contain a certain number of non-human genome samples. common microbial samples;

b) wild-type samples without corresponding target mutant sequences;

c) Genotype or gene mutation samples outside the scope of the kit design.

3.4 Detection limit

National reference products and/or standardized enterprise reference products within the scope of the test kit, the test results should be positive and consistent with the corresponding mutation