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

一种新型病原体捕获样品制备装置，用于在 Genedrive 分子诊断平台上进行护理点结核病诊断

• 批准号: 104280
• 金额: $ 141.18万
• 依托单位: GENEDRIVE DIAGNOSTICS LTD
• 依托单位国家: 英国
• 项目类别: Collaborative R&D
• 财政年份: 2018
• 资助国家: 英国
• 起止时间: 2018 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=104280
• 关键词: novel; pathogen; capture; sample; preparation

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.

目前，在分子诊断测试之前，从临床样品中回收传染病靶标所需的床旁（Point-of-Care，简称POS）适用的样品处理方法有限。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。许多现场便携式分子检测系统未能实现可重复使用，因为支持它们所需的上游样品制备工作流程过于复杂，设备密集且成本高昂-妨碍了它们在分散环境中的部署。该项目将采用技术支持，并将利用我们现有的去风险工作流程，最初将在分散的非实验室环境中将我们现有的MTB测试的灵敏度提高约100倍。这将能够诊断低水平细菌感染的患者，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。它寻求整合现有技术，以实现真正的PoC TB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个低成本的样品制备消耗品设备，克服了传统的用户复杂性，生物安全性和设备的障碍，需要成功的微生物技术应用。该设备将能够分散检测痰液中的结核病，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，并在发达国家建立的医疗保健环境中。