This standard specifies the requirements, test methods, labels and instructions for use, packaging, transportation and storage of human epidermal growth factor receptor (EGFR) gene mutation detection kits. This kit is suitable for qualitative detection of EGFR gene mutations. This kit is not suitable for detecting EGFR gene copy number changes. This kit is suitable for the detection of EGFR gene mutations in DNA samples extracted from tumor tissues or cell paraffin-embedded sections and fresh frozen tumor tissues. The detection of EGFR gene mutations in peripheral blood (plasma) can be referred to and formulated in accordance with the EGFR in peripheral blood (plasma) Technical requirements required for genetic mutation detection. This kit is suitable for human EGFR gene mutation detection kit. The technical methods used include fluorescence PCR method, flow fluorescence hybridization method, fluorescence PCR melting curve method, pyrosequencing method and Sanger sequencing method. This kit is not suitable for fluorescence in situ hybridization to detect EGFR gene copy number changes; this kit is not suitable for high-throughput sequencing methods to detect EGFR gene mutations.
YY/T 1591-2017 Referenced Document
GB/T 191 Packaging.Pictorial marking for handling of goods
GB/T 29791.2 In vitro diagnostic medical devices.Information supplied by the manufacturer (labelling).Part 2:In vitro diagnostic reagents for professional use
YY/T 1591-2017 history
2017YY/T 1591-2017 Human epidermal growth factor receptor(EGFR) mutation detection kit