A novel pathogen capture sample preparation device for point of care TB diagnostics on the genedrive molecular diagnostics platform

目前，在分子诊断测试之前，从临床样本中恢复传染病目标所需的适用于护理点(PoC)的样本处理方法有限。这意味着分析仅限于集中的实验室设施，这严重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。许多现场便携式分子测试系统无法实现PoC使用，因为支持它们的上游样品准备工作流程过于复杂、设备密集且成本高昂，无法在分散的环境中部署它们。该项目将支持技术，并将利用我们现有的去风险工作流程，这将最初将我们在分散的非实验室环境中对结核分枝杆菌现有测试的灵敏度提高约100倍。这将使患者能够诊断出低水平的细菌感染，并允许分层接受适当的抗感染治疗。这项技术有机会改变在资源有限的国家的分散环境中进行血液传播病毒诊断的方式，提供更好的患者护理和更及时的治疗，并最终对全球传染病方面的健康挑战产生积极影响。它寻求整合现有技术，以实现真正的POC结核病工作流程，以便在疾病负担最高的低收入国家分散使用。该项目的成果将是一种低成本的样品制备消耗性设备，它克服了成功应用PoC所需的传统用户复杂性、生物安全性和设备障碍。该设备将实现对痰中结核病的分散检测，但也将广泛适用于一系列其他临床样本类型和传染病病原体，以及发达国家现有的医疗保健环境。

Currently there are limited Point-of-Care (PoC)-applicable sample processing methods needed to recover infectious disease targets from clinical samples prior to molecular diagnostic testing. 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. Many field portable molecular testing systems fail to achieve PoC use as the upstream sample preparation workflows needed to support the them are overly complex, equipment intensive and costly - precluding their deployment in decentralised settings. This project will be technology enabling and will capitalise on our existing derisked workflow that will initially improve sensitivity of our existing test for MTB in decentralised non-laboratory settings by an order of approximately 100-fold. This will enable diagnosis of patients with low levels of bacterial infection and also permit stratification for receipt of appropriate anti-infective treatments. 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. It seeks to integrate existing technologies to realise a true PoC TB workflow for decentralised use in low-income countries with highest disease burden. The project outcome will be a low cost, sample preparation consumable device that overcomes the traditional user complexity, biosafety and equipment barriers needed for successful PoC application. The device will enable decentralised testing of TB in sputum but will also be broadly applicable for a range of other clinical sample types and infectious disease agents, and in established healthcare settings in developed countries.