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Point-of-Care Testing即时检验
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Risk Evaluation of Point-of-Care Testing (POCT) Devices: Insights From a Tertiary Care Hospital.即时检验(POCT)设备的风险评估:来自一家三级护理医院的见解
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Vesicoureteral Reflux膀胱输尿管反流

即时检验

Point-of-Care Testing

作者信息

Larkins Michael C., Zubair Muhammad, Thombare Aparna

机构信息

East Carolina University Brody School of Medicine

Pakistan Kidney & Liver Institute and Research Centre - PKLI

PMID:37276307
Abstract

Point-of-care testing (POCT) is a type of clinical laboratory testing conducted at or near the site of patient care. POCT provides rapid turnaround of test results, with the potential to generate results quickly, allowing for the implementation of appropriate treatment and leading to improved clinical or economic outcomes compared to laboratory testing. Traditional laboratory testing typically involves a multiple-step process that includes collecting samples from the patient at the bedside or the clinic, transporting them to a centralized laboratory, often located far away, and then subjecting the samples to several processing steps. The delay in treatment caused by the time-consuming traditional laboratory testing can hinder timely clinical decision-making. POCT addresses this challenge by bringing the laboratory to the patient. Portable and handheld testing devices enable healthcare professionals to perform rapid testing on samples, significantly reducing the time needed for medical decision-making. The concept of on-site or near-patient testing for blood analysis was initially explored in England during the 1950s and was referred to as near-patient testing. In the early 1980s, Dr Gerald J Kost introduced the term  after extensive research on the application of biosensors for monitoring ionized calcium levels in whole blood. The term  was subsequently defined as the testing at or near the site of patient care. Technological advances, including the miniaturization of electronics and improved instrumentation, have facilitated the development of increasingly smaller and more accurate POCT devices. Cutting-edge POCT integrates microneedles and microfluidics for improved comfort, speed, and accuracy. Essential features of point-of-care testing include simplicity of use, with reagents and consumables that remain stable and reliable during storage and use. Test results should be consistent with those obtained from established laboratory methods, and procedures must ensure safety for both patients and healthcare personnel throughout the testing process.  Various international guidelines define key attributes of POCT. The ASSURED framework, proposed by the World Health Organization, is one of the most well-known models, particularly for infectious disease diagnostics, such as those related to sexually transmitted infections. The acronym highlights that POCT should be affordable, sensitive, specific, user-friendly, rapid, robust, equipment-free, and deliverable to end-users. Affordability makes tests accessible to at-risk patients, whereas being equipment-free means they do not need complex tools. More recently, this framework has been updated to the REASSURED criteria, which keep all the main features of ASSURED but add 2 new aspects—real-time connectivity, which links tests with health information systems, and ease of specimen collection, supporting minimally invasive sampling. Together, these criteria serve as a complete standard for developing and implementing effective POCT solutions in diverse healthcare settings. The National Academy of Clinical Biochemistry has developed evidence-based guidelines for POCT, providing grading and recommendations to optimize the use of POCT based on scientific research and clinical evidence. Developing trends in POCT include the integration of artificial intelligence and machine learning in the execution and interpretation of lab testing, as well as the continued miniaturization of POCT devices. POCT guidelines generally emphasize the rapid results and cost-effectiveness of POCT, along with the importance of high sensitivities and specificities to support informed clinical decision-making.

摘要

即时检验(POCT)是在提供护理或治疗的患者护理地点附近进行的临床实验室检测。POCT能够快速得出检测结果,有可能迅速生成结果,以便实施适当的治疗,与实验室检测相比,可带来更好的临床或经济结果。传统的实验室检测通常涉及多个步骤,包括在床边或诊所从患者采集样本,将样本运送到集中实验室(通常位于较远的地方),然后对样本进行多个处理步骤。耗时的传统实验室检测导致的治疗延迟会阻碍及时的临床决策。POCT通过将实验室带到患者身边来应对这一挑战。便携式和手持式检测设备使医护人员能够对样本进行快速检测,显著减少医疗决策所需的时间。血液分析的现场或近患者检测概念最初于20世纪50年代在英国进行探索,当时被称为“近患者检测”。20世纪80年代初,杰拉尔德·J·科斯特博士在对生物传感器用于监测全血中离子钙水平的应用进行广泛研究后,引入了“即时检验”一词。随后,“即时检验”一词被编纂为“在患者护理地点或附近进行检测”的定义。包括电子设备小型化和仪器改进在内的技术进步推动了越来越小、越来越精确的POCT设备的发展。前沿的POCT集成了微针和微流控技术,以提高舒适度、速度和准确性。POCT具有以下普遍特征:POCT应易于使用。试剂和耗材在储存和使用过程中应具有持久的耐受性。POCT结果应与既定的实验室方法一致。POCT应确保检测过程中的安全性。针对POCT的特定子集,如性传播感染(STI),存在各种指南,如世界卫生组织(WHO)的ASSURED指南。ASSURED首字母缩写代表可负担、灵敏、特异、用户友好、快速、稳健、无需设备和可交付(给最终用户),这是世界卫生组织(WHO)提出的有效POCT的关键标准。可负担是针对有感染风险的患者,无需设备意味着不需要复杂设备。美国国家临床生物化学学会(NACB)制定了基于证据的POCT指南,根据科学研究和临床证据提供分级和建议,以优化POCT的使用。POCT指南通常强调POCT的快速结果和成本效益,以及高灵敏度和特异性对支持明智临床决策的重要性。