SBIR Phase I: High performance magnetic labels for more accurate quantification of biomolecules in complex samples

小企业创新研究（SBIR）第一阶段项目的更广泛的影响/商业潜力是以更低的成本在诊所和药店等分布式测试设施提供更多的医学测试。为了实现这一目标，该项目旨在开发生物分子和细胞的标记，这些标记可以在复杂的环境中准确定量，这将有利于几种类型的诊断测试。例如，侧流测定具有许多期望的特性，包括快速结果、长保存期、最少的训练和低成本，但是对于某些应用缺乏足够的灵敏度，因为标签嵌入在使光学和电子信号失真的致密纸状材料中。相比之下，磁性检测对生物材料和塑料不敏感。该项目旨在开发磁标签，其比磁传感器更容易检测到一个数量级。我们的目标是创建一个精确和灵敏的检测系统，在任何介质或样品条件下都能同样良好地运行。该产品的可行性将通过制造这些磁性标签并在现有的测试中实施来证明，并证明与现有标签相比，灵敏度提高了一个数量级以上。拟议的项目旨在通过提供一系列磁性标签来提高复杂样品中生物分子的定量，这些标签比磁性传感器更容易检测。 光学和电子标记都是灵敏的检测方法，但可能受到样品介质的限制。光学检测受散射、自发荧光和样品几何形状的影响。电子检测对样品pH和离子强度敏感。 磁性检测对介质、生物样品甚至容器不敏感。这尤其与侧向流测定相关，侧向流测定是最常见的即时检测，其中标签被埋在纸状材料中。物理模拟已被用于识别一类磁性标签，这应该是一个数量级以上的磁传感器更容易计数，但将需要新的制造工艺。该项目的工作将涉及开发新的工具来制造这种标签，测量所生产标签的磁特性并与理论进行比较，以及与医疗设备制造商合作在现有设备中测试这种标签。

The broader impact/commercial potential of the Small Business Innovation Research (SBIR) Phase I project is to make more medical tests available at distributed testing facilities like clinics and pharmacies at a lower cost. To accomplish this, this project seeks to develop labels for biomolecules and cells which can be accurately quantified in complex environments which will benefit several types of diagnostic tests. lateral flow assays, for example, possess many desirable traits including fast results, a long shelf life, minimal training, and low cost, but lack sufficient sensitivity for some applications because the tags are embedded in a dense paper-like material that distorts optical and electronic signals. Magnetic detection, in contrast, is insensitive to biological materials and the plastics. This project seeks to develop magnetic tags which are more than an order of magnitude easier to detect with magnetic sensors. The objective is to create a precise and sensitive system for detection which operates equally well in any media or sample conditions. The feasibility of the product will be demonstrated by fabricating these magnetic labels and implementing them in existing tests and demonstrating more than an order of magnitude improved sensitivity as compared to existing labels.The proposed project seeks to improve quantification of biomolecules in complex samples by providing a line of magnetic labels which are more than an order of magnitude easier to detect with magnetic sensors. Optical and electronic labels are both sensitive methods for detection but can be limited by the sample media. Optical detection is affected by scattering, autofluorescence, and sample geometry. Electronic detection is sensitive to sample pH and ionic strength. Magnetic detection is insensitive to the media, biological samples, and even the container. This is particularly relevant to lateral flow assays, the most common point-of-care test, where labels are buried in a paper-like material. Physics simulations have been used to identify a class of magnetic labels which should be more than an order of magnitude easier to count with magnetic sensors but will require new manufacturing processes. Work on this project will involve developing new tooling to manufacture this tag, measuring the magnetic properties of the produced label and comparing to theory, and working with medical device manufacturers to test this label in existing devices.