PredictSEP: A Predictive Diagnostic Assay for Sepsis

摘要 脓毒症是由宿主免疫反应失调引起的医院死亡的主要原因 以中性粒细胞过度浸润到重要器官中为特征的感染、器官衰竭和 死亡尽管依赖于病原体鉴定的血液测试被广泛用于决定是否需要进行血液检查， 在治疗中，它们严重受限于其快速预测发病、进展和预后的能力。 从败血症中恢复过来 因此，本提案的目标是设计、开发和证明一种快速预测检测方法 使用在脓毒症中观察到的中性粒细胞的天然功能障碍环境。这 基于微流体的测定提供了中性粒细胞行为的定量，用于预测评分 反映患者的预后。第一阶段的重点是在60分钟内验证我们的检测方法。 使用由败血症患者、SIRS患者和健康人组成的样本群体， 对照第二阶段的重点是建立一个完整的检测仪器沿着与大型 患者研究和FDA批准的计划。

Abstract Sepsis is the leading cause of death in hospitals caused by a dysregulated host immune response to infection characterized by excessive neutrophil infiltration into vital organs, organ failure and death. Although blood tests relying on identification of pathogens are widely utilized to decide on treatment, they are severely limited by their ability to rapidly predict the onset, progression and recovery from sepsis. Hence, the goal of this proposal is to design, develop and demonstrate a rapid predictive assay using the native dysfunctional environment of the neutrophil observed in sepsis. This microfluidics-based assay provides quantitation of the neutrophil behavior for a predictive score reflective of the prognosis of the patient. Phase I will focus on validating our assay within 60 minutes with a sample population comprised of sepsis patients, SIRS patients, and healthy controls. Phase II will focus on building an instrumentation for the complete assay along with large patient study and plans for FDA approval.