Institute of Neuroscience and Physiology, Department of Psychiatry and Neurochemistry, Sahlgrenska Academy, University of Gothenburg, Mölndal, Sweden.
Clinical Neurochemistry Laboratory, Sahlgrenska University Hospital, Mölndal, Sweden.
Alzheimers Dement. 2023 Dec;19(12):5805-5816. doi: 10.1002/alz.13455. Epub 2023 Sep 11.
INTRODUCTION: Many people with cognitive complaints or impairment never receive an accurate diagnosis of the underlying condition, potentially impacting their access to appropriate treatment. To address this unmet need, plasma biomarker tests are being developed for use in Alzheimer's disease (AD). Plasma biomarker tests span various stages of development, including in vitro diagnostic devices (or tests) (IVDs), laboratory-developed tests (LDTs) and research use only devices (or tests) (RUOs). Understanding the differences between each test type is important for appropriate implementation into the AD diagnostic pathway and care continuum. METHODS: Authors reviewed scientific literature (PubMed, meeting abstracts and presentations, company press releases and websites) on AD plasma biomarkers. RESULTS: This article defines IVDs, LDTs, and RUOs, discusses potential clinical applications and highlights the steps necessary for their clinical implementation. DISCUSSION: Plasma biomarkers could revolutionize many areas of the AD diagnostic pathway and care continuum, but further research is needed. HIGHLIGHTS: There is a need for a minimally invasive Alzheimer's disease (AD) diagnostic tool. AD plasma biomarker tests exist at various stages of commercial development. Understanding the development stage of a test is important for its appropriate use. Plasma biomarker tests could function as a triage tool to streamline AD diagnosis. Further steps remain before AD plasma biomarkers can be used routinely.
简介:许多有认知障碍或认知损伤的人从未得到过潜在疾病的准确诊断,这可能会影响他们获得适当治疗的机会。为了解决这一未满足的需求,人们正在开发用于阿尔茨海默病(AD)的血浆生物标志物检测。血浆生物标志物检测处于不同的开发阶段,包括体外诊断设备(IVD)、实验室开发的检测(LDT)和仅供研究使用的设备(RUO)。了解每种检测类型之间的差异对于将其正确应用于 AD 诊断途径和护理连续体至关重要。
方法:作者回顾了 AD 血浆生物标志物的科学文献(PubMed、会议摘要和演示文稿、公司新闻稿和网站)。
结果:本文定义了 IVD、LDT 和 RUO,讨论了它们的潜在临床应用,并强调了将其临床实施所需的步骤。
讨论:血浆生物标志物可能会彻底改变 AD 诊断途径和护理连续体的许多领域,但还需要进一步的研究。
重点:需要一种微创的阿尔茨海默病(AD)诊断工具。AD 血浆生物标志物检测处于不同的商业开发阶段。了解检测的开发阶段对于其正确使用很重要。血浆生物标志物检测可作为一种分诊工具,用于简化 AD 诊断。在 AD 血浆生物标志物能够常规使用之前,还需要采取进一步的步骤。
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