High sensitivity multiplex testing with a novel cardiac biomarker for rapid triage of acute chest pain patients enabling healthcare efficiencies and improved patient outcomes

使用新型心脏生物标志物进行高灵敏度多重测试，可对急性胸痛患者进行快速分类，从而提高医疗保健效率并改善患者治疗结果

• 批准号: 10010540
• 金额: $ 38.22万
• 依托单位: OSLER DIAGNOSTICS LIMITED
• 依托单位国家: 英国
• 项目类别: Feasibility Studies
• 财政年份: 2021
• 资助国家: 英国
• 起止时间: 2021 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=10010540
• 关键词: sensitivity; multiplex; testing; novel; cardiac

Acute myocardial infarctions (AMI/heart attacks) are one of the most common causes of death throughout the developed world. Each year ~720,000 UK citizens attend an emergency department (ED) with acute chest pain (ACP), representing ~6% of ED visits. Whilst the majority will not be suffering an AMI, due to the life-threatening nature of these symptoms, all patients must be monitored until successfully triaged. This places a huge strain on the NHS.The Gold Standard for ACP triage relies on assessment of clinical symptoms, electrocardiogram, and elevation/changes in troponin (cTn) biomarker levels (a marker of myocardial cell-death). Since most AMI patients display negative ECG symptoms, biomarkers play a crucial role ACP triage. However, cTn takes time to reach reliable measurable levels. This limits its usefulness for those presenting with early symptoms onset and requires cTn-levels to be monitored over time (a diagnostic pathway). Furthermore, cTn requires high-sensitivity testing (hs-cTn) undertaken in the hospital laboratory. These tests are slow restricting use to long (3-hr) diagnostic pathways. This results in an extended length-of-patient-stay, impacting on patient outcomes/experience and ED efficiency/productivity. Whilst point-of-care diagnostic devices are available, none can deliver reliable high-sensitivity testing.'Cardiac-Myosin-binding-protein-C' (cMyC) is an emerging myocardial necrosis biomarker. Unlike cTn, cMyC reaches elevated levels in the blood soon after AMI onset, improving diagnostic accuracy and enabling use with early presenters. However, cMyC levels fall equally as fast with time raising reliability concerns for late presenters. There are also barriers to clinical take-up, requiring clinicians to move from the trusted Gold Standard of cTn, or pay for additional testing.Osler seek to overcome these challenges through the application of a novel point-of-care diagnostic platform for the cost-efficient and reliable, simultaneously multiplexed, high-sensitivity testing of both cMyC and hs-cTn biomarkers.

急性心肌梗死（AMI/心脏病发作）是整个发达国家最常见的死亡原因之一。每年约有720，000名英国公民因急性胸痛（ACP）到急诊科（艾德）就诊，约占艾德就诊人数的6%。虽然大多数人不会遭受AMI，但由于这些症状的危及生命的性质，必须对所有患者进行监测，直到成功分诊。ACP分诊的黄金标准依赖于临床症状、心电图和肌钙蛋白（cTn）生物标志物水平（心肌细胞死亡的标志物）的升高/变化的评估。由于大多数AMI患者显示阴性ECG症状，生物标志物在ACP分诊中起着至关重要的作用。然而，cTn需要时间才能达到可靠的可测量水平。这限制了它对那些出现早期症状发作的人的有用性，并且需要随着时间的推移监测cTn-level（诊断途径）。此外，cTn需要在医院实验室进行高灵敏度检测（hs-cTn）。这些测试是缓慢的限制使用长（3小时）诊断途径。这导致患者住院时间延长，影响患者结局/体验和艾德效率/生产力。虽然有即时诊断设备，但没有一种可以提供可靠的高灵敏度测试。“心肌肌球蛋白结合蛋白C”（cMyC）是一种新兴的心肌坏死生物标志物。与cTn不同，cMyC在AMI发作后不久就在血液中达到升高的水平，提高了诊断准确性，并使其能够用于早期患者。然而，cMyC水平随着时间的推移同样快速下降，这引起了后期演讲者的可靠性问题。临床采用也存在障碍，要求临床医生放弃值得信赖的cTn黄金标准，或支付额外检测费用。Osler寻求通过应用新型床旁诊断平台来克服这些挑战，以实现成本效益高、可靠、同时多路复用、高灵敏度的cMyC和hs-cTn生物标志物检测。