review · Clinical and Experimental Medicine
CRISPR-based diagnostic tools using Cas effector proteins, such as Cas9, Cas12, and Cas13, offer rapid, sensitive, and cost-effective alternatives to traditional nucleic acid detection methods. When integrated with biosensing and amplification technologies, these systems enable portable testing without requiring expensive laboratory infrastructure or highly skilled operators. Such features make point-of-care diagnostics feasible in underserved or rural environments, as well as for home, field, and laboratory use. Potential clinical applications span infectious diseases such as tuberculosis, malaria, Zika virus, and human papillomavirus, alongside genetic conditions like sickle cell disease and various cancers including breast and colorectal malignancies. Furthermore, pairing these platforms with machine learning and artificial intelligence can improve detection accuracy, scalability, and operational efficiency, although practical hurdles remain in deploying CRISPR tools into everyday point-of-care settings.
Standard laboratory diagnostics often rely on expensive machinery and specialised personnel, creating major barriers to healthcare access in resource-limited regions. Portable CRISPR diagnostics offer rapid, affordable, and accurate testing at the point of care. Expanding these technologies could bridge diagnostic gaps for major infectious diseases, hereditary conditions, and cancers, improving early detection and supporting personalised treatment options in remote or rural communities.
The work focuses on point-of-care diagnostics for healthcare providers, field workers, and at-home users across infectious disease, oncology, and genetic screening markets. While commercial interest is driven by the potential for portable, low-cost alternatives to centralised laboratory assays, the technology remains at a transitional stage between development and real-world deployment, with significant implementation challenges still to be resolved before reliable point-of-care integration is achieved.
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The demand for sensitive, rapid, and affordable diagnostic techniques has surged, particularly following the COVID-19 pandemic, driving the development of CRISPR-based diagnostic tools that utilize Cas effector proteins (such as Cas9, Cas12, and Cas13) as viable alternatives to traditional nucleic acid-based detection methods. These CRISPR systems, often integrated with biosensing and amplification technologies, provide precise, rapid, and portable diagnostics, making on-site testing without the need for extensive infrastructure feasible, especially in underserved or rural areas. In contrast, traditional diagnostic methods, while still essential, are often limited by the need for costly equipment and skilled operators, restricting their accessibility. As a result, developing accessible, user-friendly solutions for at-home, field, and laboratory diagnostics has become a key focus in CRISPR diagnostic innovations. This review examines the current state of CRISPR-based diagnostics and their potential applications across a wide range of diseases, including cancers (e.g., colorectal and breast cancer), genetic disorders (e.g., sickle cell disease), and infectious diseases (e.g., tuberculosis, malaria, Zika virus, and human papillomavirus). Additionally, the integration of machine learning (ML) and artificial intelligence (AI) to enhance the accuracy, scalability, and efficiency of CRISPR diagnostics is discussed, alongside the challenges of incorporating CRISPR technologies into point-of-care settings. The review also explores the potential for these cutting-edge tools to revolutionize disease diagnosis and personalized treatment in the future, while identifying the challenges and future directions necessary to address existing gaps in CRISPR-based diagnostic research.
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DOI: 10.1007/s10238-024-01540-8
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