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.
Public Health Relevance Statement: Narrative. Sepsis usually causes high hospitalization and mortality rates with total 49 million cases globally and 11 million death each year, having a significant economic and health impact. Existing diagnostic strategies are time-consuming and suboptimal in accuracy, and there is currently no reliable assessment tool for disease progression. To address these issues, NaMi Diagnostics is dedicated to developing a novel rapid diagnostic bioassay and validate its clinical utility to detect sepsis and predict the pending risk of severe illness.
Project Terms: 21+ years old; Adult Human; adulthood; Adult; Affect; Antibodies; Architecture; Engineering / Architecture; Bacteria; Biological Assay; Assay; Bioassay; Biologic Assays; Biosensing Techniques; Biosensing Technics; biosensing; Biotechnology; Biotech; Blood; Blood Reticuloendothelial System; Cause of Death; Cell Culture Techniques; cell culture; cell cultures; Cells; Cell Body; Chemistry; Data Analyses; Data Analysis; data interpretation; Cessation of life; Death; Dedications; Diagnosis; Disease; Disorder; Economics; economic; Flow Cytometry; Flow Cytofluorometries; Flow Cytofluorometry; Flow Microfluorimetry; Flow Microfluorometry; flow cytophotometry; Food; Goals; Health; Healthcare Systems; Health Care Systems; Health care facility; Health Facilities; Healthcare Facility; care facilities; Blood Tests; Hematologic Tests; Hematological Tests; Hematology Testing; Hematology; Hospitalization; Hospital Admission; Human; Modern Man; Immunoassay; Leukocytes; Blood leukocyte; Leukocytes Reticuloendothelial System; Marrow leukocyte; White Blood Cells; White Cell; white blood cell; white blood corpuscle; Metals; Methods; Morbidity - disease rate; Morbidity; mortality; Patients; Pilot Projects; pilot study; Production; Race; Races; racial; racial background; racial origin; Diagnostic Reagent Kits; diagnostic kit; test kit; Recurrence; Recurrent; Research Design; Study Type; study design; Resources; Research Resources; Risk; Salmonella; Sensitivity and Specificity; Signal Transduction; Cell Communication and Signaling; Cell Signaling; Intracellular Communication and Signaling; Signal Transduction Systems; Signaling; biological signal transduction; Sulfides; Survival Rate; Technology; Testing; Texas; Time; United States; Universities; Streptavidin; Strepavidin; Diagnostic tests; measurable outcome; outcome measurement; Outcome Measure; Risk Assessment; Blinded; Caring; Blood Sample; Blood specimen; sensor; Procedures; Clinical; Phase; Medical; Survivors; Evaluation; Measurement; Disease Progression; Collaborations; septic; Diagnostic; Whole Blood; Hour; Protocols documentation; Protocol; System; Test Result; Biotinylation; Magnetism; magnetic; experience; particle; success; antibody conjugate; Biosensor; biological sensor; skills; novel; Devices; Human Resources; Manpower; personnel; Sampling; response; Escherichia coli O157:H7; E coli O157:H7; E. coli O157:H7; O157 H7; O157H7; portability; Intervention; Intervention Strategies; interventional strategy; Manufacturer; µfluidic; Microfluidics; preventing; prevent; magnetic beads; Address; Length; Microfluidic Microchips; Microfluidic Device; Microfluidic Lab-On-A-Chip; microfluidic chip; Affinity; Data; Detection; Immune Targeting; Validation; validations; Monitor; Process; Development; developmental; point of care; nano; Pathway interactions; pathway; blood infection; bloodstream infection; Sepsis; nano particle; nano-sized particle; nanosized particle; nanoparticle; Outcome; pathogen; Consumption; Coupled; anti-microbial; antimicrobial; new diagnostics; next generation diagnostics; novel diagnostics; commercial application; prototype; commercialization; patient population; Phase I Study; phase 1 study; prognostic ability; prognostic power; prognostic utility; prognostic value; diagnostic assay; Assessment instrument; Assessment tool; specific biomarkers; clinical outcome prediction; predictor of clinical outcome; predict clinical outcome; Cost efficiency; sepsis patients; septic patients; marker validation; biomarker validation; Systemic Inflammatory Response Syndrome; Infrastructure; Rapid diagnostics; diagnostic system; diagnostic platform; Prognosis; Resource-limited setting; Low-resource area; Low-resource community; Low-resource environment; Low-resource region; Low-resource setting; Resource-constrained area; Resource-constrained community; Resource-constrained environment; Resource-constrained region; Resource-constrained setting; Resource-limited area; Resource-limited community; Resource-limited environment; Resource-limited region; Resource-poor area; Resource-poor community; Resource-poor environment; Resource-poor region; Resource-poor setting; diagnostic strategy; diagnostic approach; diagnostic tool; Primary Care; manufacture
