PredictSEP: A Predictive Diagnostic Assay for Sepsis

PredictSEP：败血症的预测诊断分析

• 批准号: 10484762
• 负责人: Ketan H Bhatt
• 金额: $ 34.27万
• 依托单位: CFD RESEARCH CORPORATION
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-07-18 至 2024-07-17
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10484762
• 关键词: Adhesions; Antibiotics; Architecture; Automation; Behavior; Biological Assay; Biological Markers; Blood Tests; Blood Vessels; Cause of Death; Cell Adhesion Molecules; Cells; Cessation of life; Clinical; Clinical Sciences; Development; Devices; Diagnostic; Disease; E-Selectin; Early Diagnosis; Endothelial Cells; Endothelium; Environment; Fluorescent Dyes; Functional disorder; Generations; Goals; Hospitals; Host Defense; Hour; Human; Immune response; Immunology; Industry; Infection; Infiltration; Inflammation; Inflammation Process; Inflammatory; Inflammatory Response; Integrins; Intercellular adhesion molecule 1; Interferon Type II; Interleukin-1 beta; Interleukin-6; Investigation; Life; Liquid substance; Lung; Machine Learning; Measurement; Microfluidic Microchips; Microfluidics; Modeling; National Institute of General Medical Sciences; Neutrophil Infiltration; Organ; Organ failure; Patients; Pattern; Peptide Hydrolases; Phase; Population; Publishing; Reactive Nitrogen Species; Reactive Oxygen Species; Recovery; Sampling; Selectins; Sepsis; Systemic Inflammatory Response Syndrome; TNF gene; Testing; Therapeutic; Time; Training; Universities; Up-Regulation; Validation; Visualization; assay development; automated algorithm; base; cell injury; chemokine; clinically relevant; cytokine; design; diagnostic assay; experimental study; extracellular; in vivo; instrumentation; interest; lithography; microbial; migration; mortality; multidisciplinary; neutrophil; novel diagnostics; particle; pathogen; patient prognosis; phase 1 study; predictive test; procalcitonin; rapid diagnosis; rapid test; recruit; screening; septic patients; treatment planning; trend

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.

抽象的 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至重要器官、器官衰竭为特征的感染 死亡。尽管依赖于病原体鉴定的血液测试被广泛用于决定 治疗中，他们快速预测发病、进展和情况的能力受到严重限制。 从败血症中恢复。 因此，本提案的目标是设计、开发和演示一种快速预测分析方法 利用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中性粒细胞行为的定量以用于预测评分 反映患者的预后。第一阶段将重点在 60 年内验证我们的检测 分钟与由脓毒症患者、SIRS 患者和健康人组成的样本群体 控制。第二阶段将侧重于构建用于完整测定的仪器以及大型仪器 患者研究和 FDA 批准计划。