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用于精确传感和可靠诊断的微量采样技术标准化

Standardization of Microsampling Technologies for Accurate Sensing and Reliable Diagnostics.

作者信息

Mora Andrea C, Mace Charles R

机构信息

Department of Chemistry, Tufts University, 62 Talbot Avenue, Medford, Massachusetts 02155, United States.

出版信息

ACS Sens. 2025 Jun 27;10(6):3795-3805. doi: 10.1021/acssensors.5c00667. Epub 2025 May 22.

Abstract

The COVID-19 pandemic demonstrated the debilitating effect of overreliance on centralized sampling and testing, and generated significant momentum to investigate and validate sample types that are alternatives to the gold standard (e.g., anterior nasal vs nasopharyngeal swabs). As a result, sample collection is trending away from traditional methods at centralized health care facilities and toward at-home or point-of-care settings with devices that enable self-collection. With shifts away from regulated environments and trained personnel, it is important to remember that reliable measurements begin with standardized sample collection. To develop microsampling technologies for applications where the outcome can impact health care decisions, it is critical to (i) fully understand the sample collected (e.g., volume, composition, biological factors) and (ii) implement engineering controls for users and clinical workflow integration (e.g., usability, volume metering) to ensure precision and accuracy of a measurement. Blood sampling, once exclusively performed via venipuncture, has made the greatest strides toward remote collection with the introduction of lancet- and microneedle-based, capillary microsampling devices. However, challenges remain toward standardizing these methods, such as ensuring that measurements are hematocrit-independent. Other sample types (e.g., nasal fluid, saliva) face similar hurdles. In this Perspective, we review the current state of self-collection microsampling technologies and highlight the need to develop tools that can (i) standardize sample collection and (ii) seamlessly integrate with current clinical workflows. Ultimately, we advocate for continued innovation as technologies that support self-collection have the potential to greatly improve the diagnostic process for patients, reduce the burden on health care workers, and advance the shift toward decentralized testing.

摘要

新冠疫情显示了过度依赖集中采样和检测的不利影响,并为研究和验证替代金标准的样本类型(如前鼻拭子与鼻咽拭子)带来了巨大动力。因此,样本采集正从集中式医疗保健机构的传统方法转向使用能够实现自我采集的设备的家庭或即时护理环境。随着远离受监管的环境和训练有素的人员,重要的是要记住,可靠的测量始于标准化的样本采集。为了开发用于结果可能影响医疗决策的应用的微量采样技术,关键是要(i)充分了解所采集的样本(如体积、成分、生物因素),以及(ii)对用户和临床工作流程整合实施工程控制(如可用性、体积计量),以确保测量的精度和准确性。血液采样曾经只能通过静脉穿刺进行,随着基于柳叶刀和微针的毛细血管微量采样设备的引入,在远程采集方面取得了最大进展。然而,在标准化这些方法方面仍然存在挑战,例如确保测量与血细胞比容无关。其他样本类型(如鼻液、唾液)也面临类似的障碍。在这篇观点文章中,我们回顾了自我采集微量采样技术的现状,并强调需要开发能够(i)标准化样本采集和(ii)与当前临床工作流程无缝整合的工具。最终,我们倡导持续创新,因为支持自我采集的技术有可能极大地改善患者的诊断过程,减轻医护人员的负担,并推动向分散式检测的转变。

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