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单分子阵列数字免疫分析技术定量神经丝轻链的评估

Evaluation of single molecule array digital immunoassay technology to quantitate neurofilament light chain.

作者信息

Midde Krishna K, Broadnax Alexa, Binion Brittany, Oglesby Thomas, Harman Jake, Edwards Mike, Myler Heather, Matys Katie, Bennett Patrick

机构信息

Biomarker Services, Pharmaceutical Product Development (PPD) Laboratories, 2244 Dabney Road, Richmond, VA 23230, USA.

出版信息

Bioanalysis. 2020 Feb;12(4):221-229. doi: 10.4155/bio-2019-0221. Epub 2020 Feb 21.

Abstract

Globally, neurodegeneration accounts for significant morbidity and mortality among the elderly. Millions of people are afflicted with neurodegenerative diseases, with the most notable cases attributed to Alzheimer's, Huntington's, amyotrophic lateral sclerosis and Parkinson's diseases. Sensitive assays that can detect proteopathic anomalies indicative of early neurodegeneration have remained elusive. Therefore, there is an urgent need for sensitive diagnostic and prognostic biomarker assays that can guide the therapeutic regimen in the clinic. Single molecule array digital immunoassay platform has sensitivity about 1000-fold higher than traditional ligand binding assays. Consequently, we are now beginning to implement ultrasensitive techniques in bioanalysis. In the current study, we evaluated single molecule array technology and report specifications to quantitate neurofilament light chain, a bona-fide biomarker for neurodegeneration. Preliminary neurofilament light screening results from 100 human geriatric cerebrospinal fluid samples displayed huge biological variation and warrants further investigation.

摘要

在全球范围内,神经退行性变是老年人发病和死亡的重要原因。数以百万计的人患有神经退行性疾病,其中最著名的病例是阿尔茨海默病、亨廷顿病、肌萎缩侧索硬化症和帕金森病。能够检测出指示早期神经退行性变的蛋白病异常的灵敏检测方法一直难以实现。因此,迫切需要灵敏的诊断和预后生物标志物检测方法,以指导临床治疗方案。单分子阵列数字免疫分析平台的灵敏度比传统配体结合分析高约1000倍。因此,我们现在开始在生物分析中应用超灵敏技术。在本研究中,我们评估了单分子阵列技术,并报告了定量神经丝轻链(一种用于神经退行性变的真正生物标志物)的规格。对100份人类老年脑脊液样本进行的初步神经丝轻链筛查结果显示出巨大的生物学差异,值得进一步研究。

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