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即时检验:现状与展望。

Point-of-care testing: state-of-the art and perspectives.

作者信息

Plebani Mario, Nichols James H, Luppa Peter B, Greene Dina, Sciacovelli Laura, Shaw Julie, Khan Adil I, Carraro Paolo, Freckmann Guido, Dimech Wayne, Zaninotto Martina, Spannagl Michael, Huggett Jim, Kost Gerald J, Trenti Tommaso, Padoan Andrea, Thomas Annette, Banfi Giuseppe, Lippi Giuseppe

机构信息

Department of Medicine, University of Padova, Padova, Italy.

Department of Pathology, Microbiology and Immunology, Vanderbilt University Medical Center, Nashville, TN, USA.

出版信息

Clin Chem Lab Med. 2024 Jun 17;63(1):35-51. doi: 10.1515/cclm-2024-0675. Print 2025 Jan 29.

DOI:10.1515/cclm-2024-0675
PMID:38880779
Abstract

Point-of-care testing (POCT) is becoming an increasingly popular way to perform laboratory tests closer to the patient. This option has several recognized advantages, such as accessibility, portability, speed, convenience, ease of use, ever-growing test panels, lower cumulative healthcare costs when used within appropriate clinical pathways, better patient empowerment and engagement, and reduction of certain pre-analytical errors, especially those related to specimen transportation. On the other hand, POCT also poses some limitations and risks, namely the risk of lower accuracy and reliability compared to traditional laboratory tests, quality control and connectivity issues, high dependence on operators (with varying levels of expertise or training), challenges related to patient data management, higher costs per individual test, regulatory and compliance issues such as the need for appropriate validation prior to clinical use (especially for rapid diagnostic tests; RDTs), as well as additional preanalytical sources of error that may remain undetected in this type of testing, which is usually based on whole blood samples (i.e., presence of interfering substances, clotting, hemolysis, etc.). There is no doubt that POCT is a breakthrough innovation in laboratory medicine, but the discussion on its appropriate use requires further debate and initiatives. This collective opinion paper, composed of abstracts of the lectures presented at the two-day expert meeting "Point-Of-Care-Testing: State of the Art and Perspective" (Venice, April 4-5, 2024), aims to provide a thoughtful overview of the state-of-the-art in POCT, its current applications, advantages and potential limitations, as well as some interesting reflections on the future perspectives of this particular field of laboratory medicine.

摘要

即时检验(POCT)正成为一种越来越流行的在更接近患者的地方进行实验室检测的方式。这种方式有几个公认的优点,比如可及性、便携性、速度快、方便、易于使用、检测项目不断增加、在适当的临床路径中使用时可降低累积医疗成本、能更好地增强患者权能和提高患者参与度,以及减少某些分析前误差,尤其是与样本运输相关的误差。另一方面,POCT也存在一些局限性和风险,即与传统实验室检测相比准确性和可靠性较低的风险、质量控制和连接问题、高度依赖操作人员(操作人员的专业知识或培训水平各不相同)、与患者数据管理相关的挑战、单个检测成本较高、监管和合规问题,如临床使用前需要进行适当验证(特别是对于快速诊断检测;RDTs),以及在这类通常基于全血样本的检测中可能仍未被检测到的其他分析前误差来源(即存在干扰物质、凝血、溶血等)。毫无疑问,POCT是检验医学的一项突破性创新,但关于其合理使用的讨论还需要进一步辩论和行动。这篇集体观点论文由在为期两天的专家会议“即时检验:现状与展望”(2024年4月4 - 5日,威尼斯)上发表的讲座摘要组成,旨在对POCT的现状、其当前应用、优点和潜在局限性进行深入概述,以及对检验医学这一特定领域的未来前景进行一些有趣的思考。

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