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.

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 感染的特征是中性粒细胞过度渗入重要器官，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 治疗，他们严重限制了他们的能力，快速预测发病，进展和 从败血症中恢复。 因此，这项提案的目标是设计、开发和演示一种快速预测分析 利用败血症时观察到的中性粒细胞天然功能失调的环境。这 基于微流控技术的检测提供了中性粒细胞行为的定量预测分数 反映了病人的预后。第一阶段将专注于在60内验证我们的检测结果 分钟数，样本人群包括脓毒症患者、全身炎症反应综合征患者和健康人 控制。第二阶段将专注于为完整的分析建立仪器，以及大型 患者研究和FDA批准的计划。