Marchesini Marta, Costantino Maria Laura, Raia Lillo, Bono Nina, Candiani Gabriele
Department of Chemistry, Materials and Chemical Engineering "G. Natta", Politecnico di Milano, Via Mancinelli 7, Milan 20131 Italy.
STMicroelectronics S.r.l., Agrate Brianza, Monza Brianza 20864 Italy.
ACS Omega. 2025 Jul 3;10(34):38328-38344. doi: 10.1021/acsomega.5c02914. eCollection 2025 Sep 2.
Point-of-Care (PoC) diagnostics are transforming healthcare by enabling rapid and accessible disease detection right at the patient's bedside. This comprehensive review examines recent advances in nucleic acid (NA)-based PoC testing, revealing how these technologies are revolutionizing molecular diagnostics. Here, we critically analyze the three key components of NA-based PoC development: (i) probe design strategies, (ii) immobilization techniques, and (iii) detection methodologies. Our analysis uncovers the complex relationship between probe density, hybridization conditions, and detection sensitivity, challenging the conventional trial-and-error approaches currently dominating the field. The review introduces a novel classification of detection methods based on equipment requirements, offering valuable insights for developing truly accessible diagnostic solutions. Notably, we highlight that colorimetric and electrochemical detection methods show superior potential in meeting the REASSURED criteria (Affordable, Sensitive, Specific, User-friendly, Rapid and Robust, Equipment-free, Real-time connectivity, Ease of specimen collection, and Deliverable to end-users). These criteria are essential for global healthcare implementation. Despite major advances, significant gaps remain between laboratory innovations and practical, affordable diagnostic products. We suggest that prioritizing equipment-free detection methods and enhancing standardization could accelerate the translation of these PoC technologies into clinical practice. This review outlines a strategic roadmap for advancing NA-based PoC diagnostics, emphasizing the potential to transform healthcare delivery worldwide through accessible, rapid, and reliable molecular testing.
即时检测（PoC）诊断技术正在改变医疗保健方式，它能够在患者床边实现快速且便捷的疾病检测。这篇全面综述探讨了基于核酸（NA）的即时检测的最新进展，揭示了这些技术如何正在革新分子诊断。在此，我们批判性地分析基于核酸的即时检测开发的三个关键组成部分：（i）探针设计策略，（ii）固定技术，以及（iii）检测方法。我们的分析揭示了探针密度、杂交条件和检测灵敏度之间的复杂关系，对目前该领域占主导地位的传统试错方法提出了挑战。该综述基于设备要求引入了一种新颖的检测方法分类，为开发真正易于使用的诊断解决方案提供了有价值的见解。值得注意的是，我们强调比色法和电化学检测方法在满足REASSURED标准（可负担、灵敏、特异、用户友好、快速且稳健、无需设备、实时连接、易于样本采集以及可交付给最终用户）方面显示出卓越潜力。这些标准对于全球医疗保健的实施至关重要。尽管取得了重大进展，但实验室创新与实用且可负担的诊断产品之间仍存在显著差距。我们建议优先考虑无需设备的检测方法并加强标准化，这可以加速这些即时检测技术转化为临床实践。这篇综述概述了推进基于核酸的即时检测诊断的战略路线图，强调了通过可获取、快速且可靠的分子检测改变全球医疗保健服务的潜力。
