Centrifuge-free plasma separation consumable for global point of care viral diagnostics

目前，没有合适的独立的血液分析方法来处理患者血液样品以提供用于医学诊断测试的血浆。这意味着分析仅限于集中的实验室设施，这显著影响了结果和后续治疗的时间以及医疗保健提供者的成本。该项目旨在利用一次性检测盒的开发，该检测盒可以简单地处理来自患者手指采血样本的全血，以提供血浆用于下游的血液传播病毒检测。血浆可与Genedrive®丙型肝炎（HCV）诊断检测试剂或任何其他供应商平台和使用血浆作为起始样本的诊断检测试剂一起使用。提供能够在不依赖于临床实验室设备的情况下处理血液的盒将显著影响在低资源环境中提供许多分子诊断测试，在低资源环境中需要绝大多数传染病诊断。我们已经建立了一个基于尺寸排阻的血浆病毒分离的工作原型，其中血细胞被捕获，较小的病毒颗粒（例如，HCV）与血浆一起穿过膜。一次性使用器械的灵敏度在临床使用要求的范围内。这项技术有机会改变在资源有限的国家分散环境中进行血源性病毒诊断的方式，提供更好的患者护理和更及时的治疗，并最终对传染病的全球健康挑战产生积极影响。

Currently there are no suitable independent PoC methods for processing patient blood samples to provide plasma for medical diagnostic tests. This means analysis is restricted to centralised laboratory facilities and this significantly impacts time to result and subsequent treatment, and cost to the healthcare provider. This project seeks to capitalise on development of a single-use cartridge that can simply process whole blood from a patient finger-prick blood sample to provide plasma for downstream blood borne virus testing. Plasma can be used with Genedrive® diagnostic tests for hepatitis C (HCV), or any other vendor platforms and diagnostic tests that use plasma as a starting sample. Providing a cartridge that can process blood without relying on clinical laboratory equipment, will significantly impact the provision of many molecular diagnostic tests in low resource settings, where the vast majority of infectious disease diagnostics are required. We have established a working prototype for plasma virus separation based on size exclusion where blood cells are trapped and smaller viral particles (eg. HCV) move through a membrane with the plasma. The sensitivity of the single use device is within the ranges required for clinical use. This technology has the opportunity to change the way blood borne viral diagnostics are conducted in decentralised settings in resource limited countries, providing improved patient care and more timely therapy, and ultimately positively impacting on global health challenges in infectious diseases.