Proof of Market and Feasibility Study for Point-of Care SAMBA Respiratory Multiplex Test

全球每年约有425万人死于呼吸道感染。在英国，许多患者因疑似流感感染而去看他们的家庭医生，大量患者被送往医院。由于流感感染与包括普通感冒在内的许多其他感染疾病有许多共同的症状，患者经常被错误地对待。目前，还没有简单准确的护理点检测(POC)可以用于快速诊断感染，医生依靠症状进行诊断。世界卫生组织已将开发准确的呼吸道病毒感染POC测试列为优先事项。这种测试的发展可能会改变医生评估和治疗急性呼吸道感染患者的方式。快速诊断引起呼吸道感染的病毒将使正确的治疗得以实施，从而降低高危人群的发病率和死亡率，从而为患者带来更好的治疗，并为医疗保健提供者节省资源和成本。然而，在开发这样的测试之前，诊断制造商了解临床医生对测试的要求是至关重要的。该项目的目标是：1)通过确定临床和健康经济需求，加深对POC检测用于诊断呼吸道感染的市场的了解；2)确定开发用于DRW CE标志的Samba平台的检测的可行性。DRW将利用这些信息为开发一种用于诊断呼吸道病毒感染的创新的多重诊断POC测试提供信息，并降低其财务风险。

Respiratory infections cause around 4.25 million deaths worldwide every year. In the UK, many patients visit their GP for a suspected flu infection and large numbers are hospitalised. Since a flu infection shares many symtoms with a number of other infections, including the common cold, patients are often treated incorrectly. Currently, there is no simple accurate point-of-care test (POC) that can be used to quickly diagnose infections, and doctors rely on symptoms for diagnosis. The World Health Organisation has listed development of accurate POC tests for respiratory viral infections as a priority. Development of such a test may transform the way doctors assess and treat patients with acute respiratory infections. Rapid diagnosis of the virus causing the respiratory infections would allow the correct treatment to be administered, thereby reducing morbidity and mortality in at-risk groups, leading to better treatment for patients and resource and cost savings for healthcare providers. However, before such as test is developed it is critical that diagnostic manufactureres understand the clinicians requirement for the test. The objective of this project is to 1) generate understanding of the market for a POC test to diagnose respiratory infections by determining the clinical and health enconomic requirements and 2) determine the feasibility of developing the test for use on DRW's CE marked SAMBA platform. DRW will use this information to inform the development of, and reduce the financial risk of, developing an innovative multiplex diagnostic POC test for the diagnosis of respiratory viral infections.