Leonardo Iaccarino, Avid Radiopharmaceuticals (a wholly owned subsidiary of Eli Lilly and Company, Indianapolis, IN, USA), 3711 Market St., Philadelphia, PA 19104, USA, Ph. +1-215-298-0700, Fax +1-215-754-4950,
J Prev Alzheimers Dis. 2023;10(3):426-442. doi: 10.14283/jpad.2023.43.
Amyloid and tau biomarkers for Alzheimer's disease are widely recognized diagnostic tools for the identification of Alzheimer's disease pathology antemortem and are recommended by the most recent clinical and research guidelines. Approved biomarkers include positron emission tomography (PET)- and fluid-based markers derived from cerebrospinal fluid and, more recently, plasma. These biomarkers are still infrequently used in clinical practice, potentially due to challenges in access to and understanding of individual assay information and methodology. We provide an overview of the diagnostic biomarkers for amyloid and tau pathology that are currently available in the US and/or EU for clinical use. Available performance data from both labels/instructions for use and the scientific literature (with focus on autopsy or PET as standard of truth) are summarized to help healthcare providers navigate the biomarker landscape. All available PET amyloid and tau biomarkers demonstrate high accuracy in identifying amyloid and tau Alzheimer's disease pathology, respectively, at autopsy. Among cerebrospinal fluid biomarkers, all showed accurate prediction of Alzheimer's disease pathology, either based on autopsy or PET findings; greater accuracy was evident for concentration ratios (Aβ42/40 or P-tau181/Aβ42) versus individual biomarker concentrations. Among plasma biomarkers, Aβ42/40 and P-tau181 demonstrated high agreement with PET findings. Overall, we conclude that commercially available PET, cerebrospinal fluid and plasma assays accurately identify Alzheimer's disease amyloid and tau pathology. The recent development of fully automated tests for fluid-based biomarkers improves test reliability. The continued development of plasma biomarkers holds promise for the future management of patients with Alzheimer's disease.
淀粉样蛋白和 tau 生物标志物已被广泛认可为阿尔茨海默病病理学的诊断工具，用于生前鉴定阿尔茨海默病病理学，并被最新的临床和研究指南推荐。已批准的生物标志物包括正电子发射断层扫描（PET）和源自脑脊液的基于液体的标志物，以及最近的血浆标志物。这些生物标志物在临床实践中仍未得到广泛应用，可能是由于在获取和理解个体检测信息和方法方面存在挑战。我们提供了目前在美国和/或欧盟可用于临床的淀粉样蛋白和 tau 病理诊断生物标志物的概述。从标签/使用说明和科学文献中（重点是尸检或 PET 作为标准）汇总了可用的性能数据，以帮助医疗保健提供者了解生物标志物领域。所有可用的 PET 淀粉样蛋白和 tau 生物标志物在尸检中分别在识别淀粉样蛋白和 tau 阿尔茨海默病病理学方面均表现出高准确性。在脑脊液生物标志物中，所有标志物均根据尸检或 PET 结果准确预测阿尔茨海默病病理学；浓度比（Aβ42/40 或 P-tau181/Aβ42）与单个标志物浓度相比，准确性更高。在血浆生物标志物中，Aβ42/40 和 P-tau181 与 PET 结果高度一致。总体而言，我们得出结论，商业上可用的 PET、脑脊液和血浆检测可准确识别阿尔茨海默病的淀粉样蛋白和 tau 病理学。最近开发的用于基于液体的生物标志物的全自动测试提高了测试可靠性。血浆生物标志物的持续发展为未来阿尔茨海默病患者的管理带来了希望。
