Preparation method of gene mutation and fusion gene positive reference

Abstract

The invention aims to provides a preparation method of a gene mutation and fusion gene positive reference. The preparation method comprises the following steps: with a lentivirus or a retrovirus, usedfor integrating a foreign gene in a cell genome, as a vector, preparing a sequence meeting different gene mutations or fusion genes, and after the sequencing validation is error-free, embedding in the cell genome through the virus, screening out a monoclonal cell line with gene mutation or fusion gene from a drug, thereby obtaining the continual positive reference. The cell line is preferably 293T cell line, the mutation can be conducted at a single mutation site of a single gene, multiple site mutations of a single gene and multiple site mutations of multiple genes, and the fusion gene canbe a single fusion gene,and can also be multiple fusion genes connected in series. The preparation method has the advantages of being rapid, accurate, simple, low in cost, high in sensitivity, and capable of realizing mass production, and application and popularization in the markets are facilitated.

Description

technical field [0001] The invention belongs to the field of gene detection, and particularly provides a method for preparing a positive reference product for gene mutation and fusion gene. Background technique [0002] As we all know, genetic diagnosis is a field that has developed extremely rapidly in recent years. Genetic detection is required in the molecular diagnosis and targeted therapy of tumors, the determination of pathogens of infectious diseases, and the genotype (SNP) detection or analysis of individualized treatment of other diseases. technology, and therefore, there is an increasing clinical need for genetic testing. Currently widely used detection methods such as next-generation sequencing technology (Next-generation sequencing technology), amplification resistance mutation system (Amplification refractory mutation system, ARMS)-PCR, digital PCR (Digital PCR, dPCR) technology, etc., according to these technologies, are being Develop corresponding gene detect...

AI Technical Summary

Problems solved by technology

If the setting of the reference product is unreasonable or has defects, it will cause major problems in the selection of raw materials for the entire product, the determination of the production process, and the composition of the reaction system, resulting in the quality of the product not being safe and effective for clinical use. It is easy to have wrong results in the process of clinical testing and affect clinical diagnosis and treatment

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