POC 2-D Diffusion Assay for self-monitoring of BNP

用于 BNP 自我监测的 POC 2-D 扩散测定

• 批准号: 9020316
• 负责人: Ashutosh Chilkoti
• 金额: $ 17.76万
• 依托单位: BIOSTEALTH, INC.
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-19 至 2016-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9020316
• 关键词: POC; Diffusion; Assay; self; monitoring

DESCRIPTION (provided by applicant): The objective of this STTR proposal is to develop a 2-D diffusion point-of-care assay (POC) for B-type natriuretic peptide (BNP). The primary goal of the proposed work is to create a test format that will allow patients with chronic heart failure to quantitatively self-monitor serum levels of BNP. Determination of baseline level of BNP and changes in this level over time have prognostic utility in patients presenting with acute coronary syndromes and acute heart failure, and data suggest that monitoring levels over time may be a useful adjunct to traditional clinical evaluation by chronic monitoring of volume status in heart failure patients and potentially in guiding their treatment. While the applications of point-of-car testing of BNP in the outpatient clinic setting are obvious, quantitative devices remain cumbersome and are not well suited to patient engagement in their own monitoring and care. In this proposal, we exploit technological advances that simplify real-time testing and data transmission in order to place testing in the hands of patients. This will be accomplished through the use of the 2-D diffusion assay platform, which consists of a nanoscale "nonfouling" poly(oligoethylene glycol methacrylate) brush coated glass chip that contains two types of printed microspots: "stable" microspots of capture antibodies and "soluble" microspots of detection reagents. A finger stick of blood is applied to the chip, and the protein analytes in the blood diffuse across the non-fouling brush and bind to stable spots of capture antibodies embedded within the brush. Simultaneously, the blood dissolves the soluble spots of fluorescently labeled detection antibodies, so that the detection antibodies can diffuse and label any analyte bound by the stable spots of capture antibodies. Detection is via a custom fluorescence detector that attaches to an Android smart phone and uses the phone's camera to record an image of the fluorescent microspots. Fluorescent spot intensities are converted to analyte concentration by a built in phone app. Images are automatically uploaded to a secure central server that allows a second analysis of the image to take place before automatically updating the patient's electronic health record. The assay incorporates a built in calibration scheme capable of minimizing many of the sampling variables inherent in POC testing. In addition, the microarray can be viewed through the custom detector by the naked eye and visually compared side-by-side with calibration spots when a smartphone is not available.

描述（由申请人提供）：该STTR提案的目的是为B型纳二硫酸含量（BNP）开发2-D扩散的护理点测定（POC）。拟议工作的主要目标是创建一种测试格式，该格式允许患有慢性心力不下的患者 BNP的定量自我监测血清水平。随着时间的推移，BNP基线水平和该水平的变化的确定在出现急性冠状动脉综合征和急性心力衰竭的患者中具有预后的效用，并且数据表明，随着时间的流逝，监测水平可能是通过长期监测心力衰竭患者的体积状态以及潜在地指导其治疗的传统临床评估的有用辅助。尽管BNP在门诊诊所环境中的车点测试的应用显而易见，但定量设备仍然繁琐，并且不太适合患者参与自己的监测和护理。在此提案中，我们利用技术进步来简化实时测试和数据传输，以将测试掌握在患者手中。这将通过使用2-D扩散测定平台来实现，该平台由纳米级“非污染” poly（寡乙基乙二醇甲基丙烯酸酯）刷涂层玻璃芯片组成，其中包含两种印刷微波子：“稳定的”捕获抗体和“溶解抗体”的“稳定” Microspots和“溶解性” Microsots。将一根血液施加到碎片上，并在 血液在非污染刷上弥漫，并结合嵌入刷子内的捕获抗体的稳定斑点。同时，血液溶解了荧光标记的检测抗体的可溶斑，因此检测抗体可以扩散并标记任何由捕获抗体稳定斑点绑定的分析物。检测是通过定制的荧光检测器，该检测器附在Android智能手机上，并使用手机的摄像头记录荧光微孔的图像。荧光斑点强度通过内置电话应用转换为分析物浓度。图像会自动上传到安全的中央服务器，该服务器允许对图像进行第二次分析，然后自动更新患者的电子健康记录。该测定包括一种内置校准方案，能够最大程度地减少POC测试中固有的许多采样变量。此外，当没有智能手机时，可以通过肉眼通过自定义检测器查看微阵列，并在视觉上与校准点并排比较。