An innovative universal point-of-care diagnostic platform delivering cost-effective, high-sensitivity and multiplexed testing targeting rapid detection and diagnosis of sepsis

创新的通用护理点诊断平台，提供经济高效、高灵敏度和多重检测，旨在快速检测和诊断脓毒症

• 批准号: 48679
• 金额: $ 38.22万
• 依托单位: OSLER DIAGNOSTICS LIMITED
• 依托单位国家: 英国
• 项目类别: Study
• 财政年份: 2020
• 资助国家: 英国
• 起止时间: 2020 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=48679
• 关键词: innovative; universal; point; care; diagnostic

Sepsis, a dysregulated immune response to infection leading to organ failure, is the leading cause of preventable death in the UK. Annually there are ~250,000 sepsis cases resulting in 46,000 deaths at a cost of ~£1.5Bn to the NHS and ~£11Bn to the UK economy.Early detection and treatment of sepsis significantly improves patient outcomes, with \>50% reduction in mortality and morbidity if treated within 1 hour of hospital admission.Procalcitonin 'PCT', realised during organ necrosis, is the leading clinically validated biomarker for sepsis. PCT is frequently tested in combination with biomarkers such as C-reactive protein 'CRP' (inflammation) to provide a putative diagnosis.For reliable detection/diagnosis, PCT assays require high-sensitivity measurement within the hospital laboratory. Such tests are slow, delaying access to urgent care. Currently \>37% of sepsis patients do not receive treatment within 1hr resulting in 14,000 preventable deaths.Whilst some devices exist enabling rapid (<15 minutes) PCT testing at point-of-care (PoC), these devices fail to deliver laboratory quality measurements thereby limiting clinical usefulness.These devices are also restricted to only a handful of biomarkers with limited multiplexing capacity (restricting follow-up/alternative testing) and are expensive.Osler seek to overcome these challenges through development of the world's first universal PoC diagnostic platform delivering real-time, high sensitivity, high multiplexed and cost-efficient testing for any of the majority of clinical biomarkers from a single drop of blood. The platform is enabled through a portfolio of advanced electroanalytical techniques.The project will further develop and demonstrate the platform for rapid high-sensitivity measurement of PCT and CRP.Key areas of focus include PCT assay development, biosensor development incorporating the PCT and CRP assays, development of the PCT/CRP test cartridge, integration of the novel test cartridge with Osler's existing measurement instrument, and demonstration of performance in comparison with conventional laboratory testing using patient blood samples.The global market for sepsis diagnostics is forecast to reach £742M by 2025 at a CAGR of 9.8%.

脓毒症是一种对感染的免疫反应失调，导致器官衰竭，是英国可预防死亡的主要原因。每年约有250，000例败血症病例，导致46，000例死亡，NHS的成本约为15亿英镑，英国经济成本约为110亿英镑。败血症的早期检测和治疗显著改善了患者的预后，如果在入院后1小时内治疗，死亡率和发病率降低>50%。降钙素原“PCT”，在器官坏死期间实现，是脓毒症的主要临床验证生物标志物。PCT经常与生物标志物如C-反应蛋白“CRP”（炎症）联合检测，以提供推定诊断。为了进行可靠的检测/诊断，PCT检测需要在医院实验室内进行高灵敏度测量。这种检测速度很慢，延误了获得紧急护理的时间。目前，37%的脓毒症患者在1小时内没有接受治疗，导致14，000例可预防的死亡。（<15分钟）在护理点（PART）进行PCT测试，这些设备不能提供实验室质量测量，从而限制了临床实用性。这些设备也仅限于少数具有有限多路复用能力的生物标志物Osler试图通过开发世界上第一个通用的血液学诊断平台来克服这些挑战，该平台可以对来自一滴血的大多数临床生物标志物中的任何一种进行实时、高灵敏度、高多重和成本效益的检测。该平台通过一系列先进的电分析技术来实现。该项目将进一步开发和演示用于快速高灵敏度测量PCT和CRP的平台。重点领域包括PCT检测开发、结合PCT和CRP检测的生物传感器开发、PCT/CRP检测盒的开发、新型检测盒与Osler现有测量仪器的集成、与使用患者血液样本的传统实验室检测相比，脓毒症诊断的全球市场预计到2025年将达到7.42亿英镑，复合年增长率为9.8%。