Development of A Novel Nanoparticle Biosensor for Rapid, Point-of-Care Sepsis Diagnosis and Risk Assessment

开发新型纳米颗粒生物传感器，用于快速护理点脓毒症诊断和风险评估

基本信息

批准号：
10602155
负责人：
Ke Liu
金额：
$ 22.41万
依托单位：
NAMI DIAGNOSTICS LLC
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-06-14 至 2025-05-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10602155
关键词：
Address Adult Affect Affinity Antibodies Architecture Assessment tool Bacteria Biological Assay Biosensing Techniques Biosensor Biotechnology Biotinylation Blinded Blood Blood Tests Blood specimen Caring Cause of Death Cell Culture Techniques Cells Cessation of life Chemistry Clinical Collaborations Consumption Cost efficiency Coupled Data Data Analyses Dedications Detection Development Devices Diagnosis Diagnostic Diagnostic Reagent Kits Diagnostic tests Disease Disease Progression Economics Escherichia coli O157:H7 Evaluation Flow Cytometry Food Goals Health Health care facility Healthcare Systems Hematology Hospitalization Hour Human Human Resources Immune Targeting Immunoassay Infrastructure Intervention Length Leukocytes Magnetism Manufacturer Measurement Medical Metals Methods Microfluidic Microchips Microfluidics Monitor Morbidity - disease rate Outcome Outcome Measure Pathway interactions Patients Phase Pilot Projects Primary Care Procedures Process Production Prognosis Protocols documentation Race Rapid diagnostics Recurrence Research Design Resource-limited setting Resources Risk Risk Assessment Salmonella Sampling Sensitivity and Specificity Sepsis Signal Transduction Streptavidin Sulfides Survival Rate Survivors System Systemic Inflammatory Response Syndrome Technology Test Result Testing Texas Time United States Universities Validation Whole Blood antibody conjugate antimicrobial biomarker validation commercial application commercialization diagnostic assay diagnostic platform diagnostic strategy diagnostic tool experience magnetic beads manufacture mortality nano nanoparticle novel novel diagnostics particle pathogen patient population phase 1 study point of care portability predict clinical outcome prevent prognostic value prototype response sensor septic septic patients skills specific biomarkers success

Address Adult Affect Affinity Antibodies Architecture Assessment tool Bacteria Biological Assay Biosensing Techniques Biosensor Biotechnology Biotinylation Blinded Blood Blood Tests Blood specimen Caring Cause of Death Cell Culture Techniques Cells Cessation of life Chemistry Clinical Collaborations Consumption Cost efficiency Coupled Data Data Analyses Dedications Detection Development Devices Diagnosis Diagnostic Diagnostic Reagent Kits Diagnostic tests Disease Disease Progression Economics Escherichia coli O157:H7 Evaluation Flow Cytometry Food Goals Health Health care facility Healthcare Systems Hematology Hospitalization Hour Human Human Resources Immune Targeting Immunoassay Infrastructure Intervention Length Leukocytes Magnetism Manufacturer Measurement Medical Metals Methods Microfluidic Microchips Microfluidics Monitor Morbidity - disease rate Outcome Outcome Measure Pathway interactions Patients Phase Pilot Projects Primary Care Procedures Process Production Prognosis Protocols documentation Race Rapid diagnostics Recurrence Research Design Resource-limited setting Resources Risk Risk Assessment Salmonella Sampling Sensitivity and Specificity Sepsis Signal Transduction Streptavidin Sulfides Survival Rate Survivors System Systemic Inflammatory Response Syndrome Technology Test Result Testing Texas Time United States Universities Validation Whole Blood antibody conjugate antimicrobial biomarker validation commercial application commercialization diagnostic assay diagnostic platform diagnostic strategy diagnostic tool experience magnetic beads manufacture mortality nano nanoparticle novel novel diagnostics particle pathogen patient population phase 1 study point of care portability predict clinical outcome prevent prognostic value prototype response sensor septic septic patients skills specific biomarkers success

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项目摘要

Abstract. In the United States, about 1.7 million adults affected by sepsis annually, which leads to more than 270,000 deaths per year. If sepsis cannot be diagnosed and treated early, it not only causes high morbidity and mortality rates, but also poses a major burden to the healthcare system since septic patients are generally hospitalized for extended stay and rarely discharged from ICU before 2-3 weeks. In response to this health problem, NaMi Diagnostics collaborates with Texas Tech University to develop a nanoparticle-based electrochemical testing kit to pinpoint early sign of sepsis before it progresses systemic inflammatory response syndrome (SIRS) and other serious complications. Our technology features include high sensitivity, fast turnaround results, multiplexing capability, quantitative measurement, cost-efficiency, and portability. The proposed study design is adapted from a prototype sensor architecture that has been previously applied to detect food pathogens such as E. coli O157:H7 and Salmonella yet utilizes sepsis-specific cell markers validated in a microfluidic platform by our project collaborator. Specifically, the key component of our testing platform includes functionalized magnetic particles for isolation of target immune cells specific to sepsis and employs different types of modified metal sulfide nanoparticles for identification and detection, producing nearly real-time diagnostic answers, enabling prompt medical intervention, and allowing long-term monitoring of sepsis survivors to prevent the recurrence of sepsis. The proposed workflow is simple, requiring minimal infrastructure and labor, and can be readily implemented in point-of-care and resource-limited settings. The goal of upcoming Phase I project at NaMi Diagnostics will be demonstrating the feasibility for sensitive and simultaneous detection of leukocytes with upregulated CD64 and CD69 expression as proof-of-concept for early and accurate sepsis diagnosis. To validate the prognostic value for severe disease, correlation between testing result and clinical outcome in sepsis patients will be also explored in this study.

抽象的。在美国，每年约有170万成年人受败血症影响，这导致超过每年270,000人死亡。如果败血症无法及早诊断和治疗，不仅会引起高发病率和死亡率，但也给医疗系统带来了重大负担，因为化粪池患者通常是住院治疗长期住院，很少在2-3周之前从ICU出院。回应这种健康问题，NAMI Diagnostics与德克萨斯理工大学合作开发了基于纳米颗粒的电化学测试套件以在进行全身炎症反应之前查明败血症的早期迹象综合征（SIRS）和其他严重的并发症。我们的技术功能包括高灵敏度，快速周转结果，多路复用能力，定量测量，成本效益和便携性。这拟议的研究设计是根据原型传感器结构改编的，该原型架构以前已应用于检测食品病原体，例如大肠杆菌O157：H7和沙门氏菌，但使用败血症特异性细胞标记我们的项目合作者在微流体平台上验证。具体而言，我们测试的关键组成部分平台包括功能化的磁性颗粒，用于隔离特定于败血症和的靶标免疫细胞采用不同类型的改良金属硫化物纳米颗粒进行识别和检测，几乎产生实时诊断答案，实现及时的医疗干预，并允许长期监控败血症幸存者可以防止败血症复发。提出的工作流程很简单，需要最少基础架构和劳动力，可以在护理和资源有限的设置中容易实施。这 NAMI Diagnostics I阶段项目的目标是证明敏感和敏感的可行性同时检测白细胞具有上调的CD64和CD69表达式作为概念概念的证明早期，准确的败血症诊断。为了验证严重疾病的预后价值本研究还将探讨败血症患者的测试结果和临床结果。