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

败血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25万例败血症病例，导致4.6万人死亡，给NHS造成约15亿英镑的损失，给英国经济造成约110亿英镑的损失。早期发现和治疗败血症可显著改善患者预后，如果在入院后1小时内进行治疗，死亡率和发病率可降低50%。降钙素原（PCT），在器官坏死期间实现，是败血症的主要临床验证生物标志物。PCT通常与c反应蛋白（CRP）等生物标志物（炎症）联合检测，以提供推定诊断。为了可靠的检测/诊断，PCT检测需要在医院实验室进行高灵敏度测量。这种检测速度缓慢，延误了获得紧急护理的时间。目前，37%的败血症患者未能在1小时内接受治疗，导致1.4万例可预防的死亡。虽然现有的一些设备可以在护理点（PoC）进行快速（<15分钟）PCT检测，但这些设备无法提供实验室质量测量，从而限制了临床用途。这些设备也仅限于少数生物标记物，多路复用能力有限（限制后续/替代测试），而且价格昂贵。奥斯勒寻求通过开发世界上第一个通用PoC诊断平台来克服这些挑战，提供实时，高灵敏度，高复用和高成本效益的测试，从一滴血中检测任何大多数临床生物标志物。该平台是通过一系列先进的电分析技术实现的。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分析开发，结合PCT和CRP分析的生物传感器开发，PCT/CRP测试盒的开发，新型测试盒与奥斯勒现有测量仪器的集成，以及与使用患者血液样本的传统实验室测试相比的性能演示。到2025年，全球败血症诊断市场预计将达到7.42亿英镑，复合年增长率为9.8%。

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%.