I-Corps: Silk Stabilization Technologies

普遍存在的存储和传输问题目前限制了诊断测试的准确性和用于远程使用的鲁棒测试设备的分布。这些问题源于灵敏定量所需的分子和试剂的固有温度稳定性，包括抗体、酶、蛋白质标准品和测试样本本身（即全血、唾液、尿液等）。这个I-Corps团队提出了一个技术平台，该平台基于使用丝素蛋白作为稳定剂，可用于保护这些分子在环境温度下免受降解，这反过来又可以扩大现场部署的诊断设备的用例，将降低与冷藏相关的成本，提高宝贵的内部标准品或传感器上固定的化学物质的保质期，并且潜在地使流体生物样本的取回更加可行。丝技术平台为诊断领域内的商业开发提供了许多潜在途径。该团队进行的初步工作集中在调整蚕丝纯化和格式化，以改善其稳定特性（即热保护/改善恢复），以满足现场环境的需求。该团队最近还证明了丝基质在大量测试标记物中提供的热稳定性增强，并证明了与许多不同测试技术的兼容性，如免疫测定，定量实时PCR和各种高通量方法。该团队建议将这些核心概念简化为对热稳定性差的现有产品进行改造，并开发该技术支持的新产品，包括即时护理设备和含有不稳定试剂的样品瓶。I-Corps的资金将支持开发一种原型设备，该设备包含干燥的蚕丝基质，可用于在符合人体工程学的廉价消耗品上捕获和干燥毛细血管血液。

There are pervasive storage and transport problems that currently limit the accuracy of diagnostic tests and distribution of robust testing devices for remote usage. These problems stem from the inherent temperature stabilities of the molecules and reagents required for sensitive quantitation including antibodies, enzymes, protein standards, and the test specimens themselves (i.e. whole blood, saliva, urine, etc.). This I-Corps team proposes a technology platform based on using silk fibroin as a stabilizer that can be used to protect these molecules from degradation at ambient temperatures, which in turn can expand the use cases of diagnostic devices deployed in the field, will reduce the costs associated with cold storage, improve the shelf life of precious internal standards or immobilized chemistries on sensors, and potentially make the retrieval of fluid bio-specimens more feasible.The silk technology platform offers many potential avenues for commercial development within the field of diagnostics. The initial work conducted by this team has focused on adapting silk purification and formatting to improve its stabilizing features (i.e. thermal protection / improved recovery) for needs in field settings. The team has also recently demonstrated thermal stability enhancements provided by the silk matrix across a wide number of test markers and demonstrated compatibility with numerous distinct testing techniques such as immunoassays, quantitative real-time PCR, and various high-throughput approaches. The team proposes the reduction of these core concepts to the retrofitting of existing products with poor thermal stability and the development of new products enabled by the technology, including point-of-care devices and sample vials containing labile reagents. I-Corps funds will support the development of a prototype device that incorporates a dried silk matrix and can be used to capture and dry capillary blood on an ergonomic and inexpensive consumable.