CRISPR/Cas系统在分子诊断领域的应用研究进展

王珂; 陈文慧; 雷春阳; 聂舟

doi:10.12211/2096-8280.2025-042

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CRISPR/Cas系统在分子诊断领域的应用研究进展

特约评述 | 更新时间：2026-03-07

- CRISPR/Cas系统在分子诊断领域的应用研究进展
- Advances in the application of CRISPR/Cas systems in molecular diagnostics
- 合成生物学 2026年7卷第1期页码：3-31
- 作者机构：
  
  1.湖南大学化学化工学院，化学生物传感全国重点实验室，湖南长沙 410012
  2.空军军医大学药学系，陕西西安 710032
- 作者简介：
  
  [ "王珂（1995—），女，博士，讲师。研究方向：基于CRISPR/Cas系统的可编程分子识别与信号放大机制，开发工程化高灵敏、高特异的生物传感平台，用于环境监测及疾病诊断等生命科学场景中的创新应用。E-mail：wangke123@fmmu.edu.cn" ]
  [ "聂舟（1982—），男，博士，教授，博士生导师。研究方向：围绕功能核酸理性设计及其生物传感与成像、细胞信号通路调控应用等方面开展了深入研究，系统建立了基于物理/化学信号响应型核酸工具调控细胞受体信号通路的细胞功能重编程技术，以及RNA结构靶向活细胞/活体成像技术。 E-mail：niezhou@hnu.edu.cn" ]
- 基金信息：
  
  国家自然科学基金(22034002)
- DOI：10.12211/2096-8280.2025-042
  中图分类号： Q816
- 收稿：2025-05-07，
  
  修回：2025-06-18，
  
  纸质出版：2026-02-28
- 稿件说明：
移动端阅览
王珂，陈文慧，雷春阳，聂舟. CRISPR/Cas系统在分子诊断领域的应用研究进展［J］. 合成生物学， 2026， 7（1）： 3-31

WANG Ke， CHEN Wenhui， LEI Chunyang， NIE Zhou. Advances in the application of CRISPR/Cas systems in molecular diagnostics［J］. Synthetic Biology Journal， 2026， 7（1）： 3-31
王珂，陈文慧，雷春阳，聂舟. CRISPR/Cas系统在分子诊断领域的应用研究进展［J］. 合成生物学， 2026， 7（1）： 3-31 DOI： 10.12211/2096-8280.2025-042.

WANG Ke， CHEN Wenhui， LEI Chunyang， NIE Zhou. Advances in the application of CRISPR/Cas systems in molecular diagnostics［J］. Synthetic Biology Journal， 2026， 7（1）： 3-31 DOI： 10.12211/2096-8280.2025-042.

摘要

CRISPR/Cas系统因其高特异性、可编程性和便捷性，已成为分子诊断领域的重要工具。本文综述了CRISPR/Cas系统的技术原理、诊断平台优化及其在精准医学中的应用进展。概述了CRISPR/Cas系统的作用机制与分类，重点讨论了CRISPR诊断技术的创新优化策略，包括基于核酸预扩增［如SHERLOCK（specific high-sensitivity enzymatic reporter unlocking）、DETECTR（DNA endonuclease targeted CRISPR trans reporter）］和免扩增的检测方法。探讨了CRISPR/Cas技术在感染性疾病（病原体筛查、耐药性检测）、肿瘤分子分型（癌症早筛、遗传变异分析）及非核酸标志物检测中的临床应用。最后展望了该技术的未来发展方向，包括微型化设备开发、高通量智能化诊断体系构等，并分析了其在临床转化中面临的关键挑战（如灵敏度标准化、成本控制等）。通过总结目前研究，为CRISPR/Cas技术在分子诊断领域的进一步优化和医学应用提供理论参考。

Abstract

The CRISPR/Cas system has emerged as a pivotal tool in molecular diagnostics due to its high specificity

programmability

and ease of use. This review provides a comprehensive overview of the mechanistic principles

diagnostic platform optimization

and applications of CRISPR/Cas systems in precision medicine. We begin with an outline of the classification and molecular mechanisms of CRISPR/Cas systems

highlighting the functional differences among Type Ⅰ-Ⅵ systems. Our focus then shifts to innovative diagnostic strategies

including nucleic acid pre-amplification methods (

SHERLOCK

DETECTR) and amplification-free approaches. These strategies have significantly enhanced the sensitivity and specificity of molecular

diagnostics

making them more efficient and reliable than conventional techniques. The review then explores the broad clinical applications of CRISPR/Cas technology with infectious diseases

such as pathogen screening and drug-resistance detection

demonstrating remarkable utilization in rapidly identifying pathogens and their resistance profiles. In the field of cancer research

the technology has shown great potential in early screening and genetic variant analysis

which are crucial for developing personalized treatment strategies. Moreover

CRISPR/Cas systems are expanding their diagnostic capabilities to include non-nucleic acid biomarker detection

further solidifying their position as versatile tools in clinical diagnostics. The review also addresses future directions in the field

such as the development of miniaturized devices and high-throughput intelligent diagnostic systems. These advancements are expected to enhance portability

accessibility

and efficiency

enabling rapid point-of-care testing in diverse settings

including resource-limited environments. The integration of CRISPR technology with microfluidics and portable detection devices is particularly promising for enabling rapid and accurate diagnostics at the bedside or in the field. As research continues to evolve

the ongoing refinement of CRISPR/Cas systems is anticipated to significantly improve the accuracy

speed

and accessibility of molecular diagnostics. This progress is expected to lead to better clinical outcomes and more effective public health responses. However

several challenges in clinical translation must be addressed

such as standardization of sensitivity and cost reduction. This review aims to provide a theoretical basis for advancing CRISPR-based diagnostics in biomedical research and to guide the future development of CRISPR/Cas technologies in molecular diagnostics

particularly in overcoming the limitations of traditional diagnostic methods.

关键词

Keywords

references

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