转基因与基因编辑产品检测方法研究进展

doi:10.19586/j.2095-2341.2026.0130

生物技术进展 ›› 2026, Vol. 16 ›› Issue (4): 744-755.DOI: 10.19586/j.2095-2341.2026.0130

转基因与基因编辑产品检测方法研究进展

张华¹(), 张雨腾²^,³, 裴欣瑶¹, 杨立桃²^,³()

^1.农业农村部科技发展中心，北京 100176
^2.上海交通大学海南研究院，海南三亚 572000
^3.上海交通大学生命科学技术学院，上海 200240

收稿日期:2026-06-01 接受日期:2026-07-31 出版日期:2026-07-25 发布日期:2026-09-11
通信作者: 杨立桃
作者简介:张华 E-mail: gmotest@126.com；
基金资助:
上海市科技创新行动计划项目(24DZ2201300);上海市科技创新行动计划项目(24390713700)

Research Progress on Detection Methods of Genetically Modified and Gene-edited Products

Hua ZHANG¹(), Yuteng ZHANG²^,³, Xinyao PEI¹, Litao YANG²^,³()

^1.Science and Technology Development Center，the Ministry of Agriculture and Rural Affairs，Beijing 100176，China
^2.Hainan Research Institute，Shanghai Jiao Tong University，Hainan Sanya 572000，China
^3.College of Life Science and Biotechnology，Shanghai Jiao Tong University，Shanghai 200240，China

Received:2026-06-01 Accepted:2026-07-31 Online:2026-07-25 Published:2026-09-11
Contact: Litao YANG

摘要/Abstract

摘要：

随着转基因作物商业化规模持续扩大及基因编辑等新型生物技术的迅速应用，新型生物技术产品种类日益复杂、多样，构建灵敏、准确、可溯源的新型生物技术产品检测方法和体系已成为保障食品安全、支撑标签管理与监管执法的重要基础。系统综述了2025年转基因、基因编辑等新型生物技术产品检测领域的研究进展，重点涵盖样品前处理、核酸扩增检测（实时荧光定量PCR、数字PCR）、等温扩增、成簇规律间隔短回文重复序列及其相关蛋白（clustered regularly interspaced short palindromic repeats-Cas protein，CRISPR/Cas）辅助检测、生物传感与免疫检测、高通量测序，以及数据库与监管支撑体系等方面。总体而言，实时荧光定量PCR仍是转基因成分定量分析的核心方法；数字PCR在低拷贝靶标绝对定量检测和参考物质定值中优势突出；等温扩增与生物传感技术持续推动检测向快速化、现场化方向发展；高通量测序正为基因编辑产品识别提供更高分辨率的技术支撑。未来，相关检测技术将进一步朝多技术联用、多靶标同步识别、智能化分析与监管适配并行的方向演进。

关键词: 转基因产品, 基因编辑产品, 检测方法, CRISPR/Cas, 高通量测序

Abstract:

With the continuous expansion in the commercialization scale of genetically modified （GM） crops and the rapid application of emerging biotechnologies such as gene editing， products derived from these novel biotechnologies have become increasingly complicated and diversified. Establishing sensitive， accurate and traceable detection methodologies and systems for such biotech products serves as an essential foundation for food safety assurance， labeling administration as well as regulatory law enforcement. The article systematically reviewed the research advances in the detection of GM and gene-edited products and other novel biotech-derived products in 2025， focusing on sample pretreatment， nucleic acid amplification assays （including quantitative real-time PCR and digital PCR）， isothermal amplification， clustered regularly interspaced short palindromic repeats-Cas protein （CRISPR/Cas）-assisted detection， biosensing and immunoassays， high-throughput sequencing， alongside databases and regulatory supporting systems. Overall， quantitative real-time PCR （qPCR） remains the core technique for quantitative analysis of genetically modified ingredients； digital PCR （dPCR） exhibits prominent advantages in absolute quantification of low-copy target sequences and value assignment of reference materials. Isothermal amplification and biosensing technologies keep facilitating the development of rapid and on-site detection. High-throughput sequencing provides technical support with superior resolution for the identification of gene-edited products. In the future， relevant detection technologies will further evolve toward the integrated application of multiple techniques， simultaneous identification of multi-target analytes， intelligent data analysis and compatibility with regulatory requirements.

Key words: genetically modified products, gene-edited products, detection methods, CRISPR/Cas, high-throughput sequencing

中图分类号:

Q-33

张华, 张雨腾, 裴欣瑶, 杨立桃. 转基因与基因编辑产品检测方法研究进展[J]. 生物技术进展, 2026, 16(4): 744-755.

Hua ZHANG, Yuteng ZHANG, Xinyao PEI, Litao YANG. Research Progress on Detection Methods of Genetically Modified and Gene-edited Products[J]. Current Biotechnology, 2026, 16(4): 744-755.

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链接本文: https://swjsjz.magtechjournal.com/CN/10.19586/j.2095-2341.2026.0130

https://swjsjz.magtechjournal.com/CN/Y2026/V16/I4/744

图/表 6

参考文献 46

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技术类别	代表方法	主要优势	主要局限性	适用场景
普通PCR	元件特异性PCR、构建特异性PCR、事件特异性PCR、多重PCR	操作相对简单、成本较低，适合已知靶标的快速初筛和基础鉴定	以定性或半定量分析为主，对低拷贝靶标和复杂基质样品的定量能力有限	转基因元件筛查、事件初步确认、未授权成分定性筛查
qPCR	TaqMan探针qPCR、双重qPCR、多重qPCR	灵敏度和特异性较高，定量能力成熟，标准化程度高，是监管检测中的核心方法	依赖标准曲线和参考物质；对单碱基编辑、小片段变异等靶标的识别能力受引物探针设计影响较大	转基因成分定量分析、事件特异性检测、监管阈值判定
dPCR	ddPCR、芯片数字PCR、腔室数字PCR	可实现绝对定量，无需标准曲线，适用于低拷贝、低丰度和复杂基质样品	仪器和耗材成本较高，通量和多重检测能力受平台限制，跨平台标准化仍需完善	低拷贝靶标定量、标准物质定值、基因编辑缺失位点精准识别
等温扩增	LAMP、RPA、ERA等	反应条件简单、扩增速度快，对仪器依赖较低，便于现场快速检测	非特异性扩增和污染风险相对较高，定量能力和结果标准化程度通常弱于qPCR/dPCR	现场筛查、口岸快速检测、基层实验室快速预警
CRISPR/Cas辅助检测	LAMP-CRISPR/Cas、RPA-CRISPR/Cas、ERA-CRISPR/Cas、多重CRISPR检测	兼具扩增快速性和CRISPR/Cas识别特异性，可与荧光、侧向层析和手机判读结合	体系设计较复杂，对crRNA、PAM、酶活性和反应条件依赖较强，多靶标定量和标准化验证仍需加强	转基因快速筛查、多靶标联检、现场可视化检测
免疫检测与生物传感	免疫层析试纸条、荧光侧向流免疫分析、电化学基因传感器、光谱融合检测	检测速度快、操作便捷，可实现可视化、便携化或无损识别，适合现场应用	多数方法依赖高质量抗体、探针或传感界面，对复杂基质干扰和结果定量稳定性要求较高	性状蛋白快速筛查、加工样品初筛、现场判读和快速分流
高通量测序与生物信息学分析	靶向测序、低深度NGS、长读长测序、RNA-seq、双链测序、遗传指纹分析	可同时获得插入位点、侧翼序列、突变类型和遗传背景信息，分辨率高，适合未知样品和基因编辑产品分析	成本、数据分析和数据库依赖较高，对结果解释、溯源判定和监管标准化提出更高要求	未知转基因事件识别、插入结构解析、基因编辑产品溯源和多位点分子指纹构建

技术类别	代表方法	主要优势	主要局限性	适用场景
普通PCR	元件特异性PCR、构建特异性PCR、事件特异性PCR、多重PCR	操作相对简单、成本较低，适合已知靶标的快速初筛和基础鉴定	以定性或半定量分析为主，对低拷贝靶标和复杂基质样品的定量能力有限	转基因元件筛查、事件初步确认、未授权成分定性筛查
qPCR	TaqMan探针qPCR、双重qPCR、多重qPCR	灵敏度和特异性较高，定量能力成熟，标准化程度高，是监管检测中的核心方法	依赖标准曲线和参考物质；对单碱基编辑、小片段变异等靶标的识别能力受引物探针设计影响较大	转基因成分定量分析、事件特异性检测、监管阈值判定
dPCR	ddPCR、芯片数字PCR、腔室数字PCR	可实现绝对定量，无需标准曲线，适用于低拷贝、低丰度和复杂基质样品	仪器和耗材成本较高，通量和多重检测能力受平台限制，跨平台标准化仍需完善	低拷贝靶标定量、标准物质定值、基因编辑缺失位点精准识别
等温扩增	LAMP、RPA、ERA等	反应条件简单、扩增速度快，对仪器依赖较低，便于现场快速检测	非特异性扩增和污染风险相对较高，定量能力和结果标准化程度通常弱于qPCR/dPCR	现场筛查、口岸快速检测、基层实验室快速预警
CRISPR/Cas辅助检测	LAMP-CRISPR/Cas、RPA-CRISPR/Cas、ERA-CRISPR/Cas、多重CRISPR检测	兼具扩增快速性和CRISPR/Cas识别特异性，可与荧光、侧向层析和手机判读结合	体系设计较复杂，对crRNA、PAM、酶活性和反应条件依赖较强，多靶标定量和标准化验证仍需加强	转基因快速筛查、多靶标联检、现场可视化检测
免疫检测与生物传感	免疫层析试纸条、荧光侧向流免疫分析、电化学基因传感器、光谱融合检测	检测速度快、操作便捷，可实现可视化、便携化或无损识别，适合现场应用	多数方法依赖高质量抗体、探针或传感界面，对复杂基质干扰和结果定量稳定性要求较高	性状蛋白快速筛查、加工样品初筛、现场判读和快速分流
高通量测序与生物信息学分析	靶向测序、低深度NGS、长读长测序、RNA-seq、双链测序、遗传指纹分析	可同时获得插入位点、侧翼序列、突变类型和遗传背景信息，分辨率高，适合未知样品和基因编辑产品分析	成本、数据分析和数据库依赖较高，对结果解释、溯源判定和监管标准化提出更高要求	未知转基因事件识别、插入结构解析、基因编辑产品溯源和多位点分子指纹构建

转基因与基因编辑产品检测方法研究进展

Research Progress on Detection Methods of Genetically Modified and Gene-edited Products

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