分子即时检测研究进展

    A Review on the Advancements in Molecular Point-of-Care Tests

    • 摘要: 分子即时检测(Point-of-care Test,POCT)是一种快速发展的核酸检验方法,主要基于等温扩增和微流控等技术,具有检验时间短、设备小、操作简单的优点,为“样本进,结果出”的检验需求提供了实现的可能,为新型冠状病毒肺炎等疫情防控和快速筛查提供了有力支撑。分子POCT诊断产品现可用于检测人乳头瘤病毒、人体免疫缺陷病毒、丙型肝炎病毒、淋球菌等病原微生物,具有检测时间短和便携化程度强等特点。但目前该技术还处于产业发展初级阶段,还需要进一步提高分子POCT产品的准确性和一致性,并完善相关质量管理办法和标准,建立标准化验证评价体系。本文综述了基于等温扩增、微流控等原理的分子POCT技术、设备和应用的最新研究进展,并对该技术未来的发展趋势进行了展望。

       

      Abstract: The Molecular Point-of-Care Test (POCT) represents a rapidly evolving nucleic acid testing method primarily grounded on isothermal amplification and microfluidic technologies. This technique provides numerous advantages including rapid testing, compact hardware, and simplicity in operation, thereby paving the way for immediate "sample in, result out" diagnostics. It serves as a powerful tool for the containment and management of epidemics such as COVID-19. Currently available molecular POCT diagnostic tools can detect various pathogenic microorganisms like human papillomavirus, human immunodeficiency virus, hepatitis C virus, and Neisseria gonorrhoeae, all while providing fast results and convenient portability. Despite its advantages, this technology remains in the nascent stages of industrial development, necessitating enhancements in the accuracy and consistency of molecular POCT products. Improvement in the relevant quality control measures and standards is required, with the establishment of a standardized validation and assessment system. This paper presents a comprehensive review of the most recent advancements in molecular POCT technologies, devices, and applications, which are underpinned by isothermal amplification and microfluidic principles. It also offers a forecast on the prospective trajectory of this technology.

       

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