四川大学学报（医学版）2025，Vol.56Issue(5)：1177-1183,7.DOI:10.12182/20250960508
实时荧光定量聚合酶链反应检测试剂盒临床前开发流程与展望
Preclinical Development Process and Prospects of Real-time Fluorescence Quantitative Polymerase Chain Reaction Detection Kits
摘要
Abstract
In recent years,real-time fluorescence quantitative polymerase chain reaction(qPCR)technology has become an essential tool for molecular diagnosis,pathogen detection,and gene expression analysis,thanks to its high sensitivity,speed,and real-time quantification capabilities.In 2022,the global market size of nucleic acid testing-related products and services,including instruments,reagents,consumables,and after-sales service support,reached 7.3 billion US dollars,with PCR-based technologies accounting for 66.7%of the market share and exhibiting a consistent growth trend.Although qPCR technology has been widely applied across multiple fields,the preclinical development of diagnostic kits—a process that includes primer design and reaction system optimization—still faces such issues as unclear procedures,non-standardized methods,and inconsistent evaluation criteria.Herein,we reviewed the guidelines,key resources,and standardized processes of qPCR assay reagent development,aiming to provide theoretical support for improving the efficiency and quality control of assay reagent development,and to discuss future directions for the optimizing and improving qPCR technology in the context of artificial intelligence.关键词
实时定量PCR/试剂开发/技术规范/临床前研究/标准化流程Key words
Real-time fluorescence quantitative polymerase chain reaction/Reagent development/Technical specifications/Preclinical research/Standardized process引用本文复制引用
汪川,李少鹤,张世融..实时荧光定量聚合酶链反应检测试剂盒临床前开发流程与展望[J].四川大学学报（医学版）,2025,56(5):1177-1183,7.基金项目
成都市科技局重大应用示范项目(No.2022-YF09-00011-SN)资助 （No.2022-YF09-00011-SN）
