YY/T 1731-2020Human gene single nucleotide polymorphisms (SNP) detection kit (English PDF)

3.1 Single nucleotide polymorphism singlenucleotidepolymorphisms; SNP

The difference of a single base sequence at the level of normal individual genome, including base conversion and transversion.

4.1 Appearance

The components of the kit should be complete and complete, no liquid leakage, and the signs and labels should be clear.

4.2 Reference product compliance

The test results of national reference materials and/or standardized corporate reference materials within the scope of the test kit should be consistent with known genotypes. The setting of reference products should follow the following principles.

a) All genotypes detectable within the scope of the kit;

b) For common genotypes in reference products, genomic DNA extracted from clinical samples or cell lines should be used;

c) In the composition of reference products used, the matrix of all genotype reference products should be the same or similar to the actual test sample matrix.

4.3 Analysis specificity

When testing specific national reference materials and/or standardized corporate reference materials, the test result should be negative.

The setting of analysis-specific reference products should follow the following principles.

a) A certain number of non-human genome samples should be included. common microbial samples;

b) A certain number of genotypes or gene mutation samples that are closely related to the target gene and outside the scope of the kit design should be included.