SBIR Phase I: Electronic Allergy Diagnostics: Photo-Immobilization as a General Strategy for Attaching Structurally and Compositionally Diverse Ligands onto a Single Support

该小型企业创新研究（SBIR）第1阶段项目旨在快速解决使用光化学连接器将小分子，合成肽，纯化蛋白质和天然粗提物固定在电化学传感器阵列上的可行性。 本研究的动机是1）需要用于疾病状态的多重、低成本诊断，其中适当的捕获配体在结构和组成上可以广泛变化，以及2）需要对结构和组成差异不敏感的一般连接方法。 具体而言，该项目旨在对药物、食物和环境过敏进行诊断。 我们建议探索使用全氟苯基叠氮化物（PFPA）化学作为反应性和非选择性的固定策略，用于建立这些不同的阵列。 第一阶段项目旨在确定一个单一的光化学协议，用于制备阵列，其中固定化材料保留生物活性。 这种方法将使高度多路复用的传感器阵列的制造中使用的床旁诊断。更广泛的影响/该项目的商业潜力是降低过敏测试的成本，使医生在病人的首次办公室访问（30分钟），以证据为基础的决定。 目前市场上可用的血清学过敏诊断利用放射性过敏吸附试验（RAST）或酶联免疫吸附测定（ELISA）。 这些测试可以是多重的，但需要一个中心实验室阅读器，一周的周转时间和每个过敏原15 -20美元的成本。 定量电化学检测与单一血清样品中100多种生物标志物的快速、多重诊断的组合将为现有技术提供显著改进。 如果成功，它将在过敏性疾病的临床诊断中具有革命性意义，从而能够在医生办公室进行快速评估，其形式明显优于实验室测试，皮肤点刺测试或食物挑战。 除了过敏诊断的商业潜力外，第一阶段SBIR项目还将开发和推广一种在单一载体上制备多种生物活性材料阵列的通用方法。 这项新技术将应用于影响我们健康的许多其他领域，例如传染病和癌症的诊断以及检测食品和环境污染物的设备。

This Small Business Innovation Research (SBIR) Phase 1 project aims to rapidly address the feasibility of using photochemical linkers to immobilize small molecules, synthetic peptides, purified proteins and crude natural extracts onto an electrochemical sensor array. This study is motivated by 1) the need for multiplexed, low cost diagnostics for disease states in which appropriate capture ligands can vary broadly in structure and composition and 2) a need for general attachment methods that are insensitive to structural and compositional differences. Specifically, this project is aimed at diagnostics for drug, food and environmental allergies. We propose to explore the use of perfluorinated phenyl azide (PFPA) chemistry as a reactive and non-selective immobilization strategy for building these diverse arrays. This Phase 1 project aims to identify a single photochemical protocol for preparing arrays in which the immobilized materials retain biological activity. This method will enable the fabrication of highly multiplexed sensor arrays for use in point-of-care diagnostics.The broader impact/commercial potential of this project is to reduce the cost of allergy testing and enable physicians to make evidence-based decisions during a patient's initial office visit (30 min). Current serological allergy diagnostics available in the market utilize a radioallergosorbent test (RAST) or an enzyme-linked immunosorbent assay (ELISA). These tests can be multiplexed, but require a central laboratory reader, a one week turn-around time and a cost of $15-20 per allergen. The combination of quantitative electrochemical detection with rapid, multiplexed diagnosis of 100+ biomarkers in a single serum sample will provide a significant improvement to existing technologies. If successful, it would be transformative in the clinical diagnosis of allergy diseases, enabling rapid evaluation at the doctor's office in a format that is significantly preferable to laboratory tests, skin-prick testing or food challenges. In addition to the commercial potential of allergy diagnostics, the Phase 1 SBIR project will develop and disseminate a general method for preparing diverse arrays of biologically-active materials on a single support. This new technology would have application in many other fields that affect our health, such as diagnostics for infectious disease and cancer and devices for the detection of food and environmental contaminants.