Neutrophil CD64 Assay for Human Sepsis and Infection

描述（由申请人提供）：该提案描述了使用专利单克隆抗体、荧光、分析软件和流式细胞术技术对白细胞分子CD64进行定量分子分析的临床实用性评估。由于炎症介质或细胞因子的分子激活，CD64在血白细胞中性粒细胞亚群上的表达迅速增加。用这种名为Leuko64的检测方法定量测量中性粒细胞CD64的表达，可以识别脓毒症、感染或组织损伤患者发生的全身性急性炎症反应。Leuko64检测预计将在对疑似感染患者进行适当治疗的分诊方面具有医疗效用，有助于对接受抗生素治疗的患者进行治疗监测，从而减少不必要的抗生素使用，从而最大限度地减少抗生素耐药生物体的发展压力。Leuko64检测是第一个利用细胞分子变化检测和监测感染和败血症免疫反应的诊断检测系统之一。本提案的目标是：1)验证Leuko64的临床性能；2)与当前医学实践中使用的临床实验室测试相比，证明其作为检测感染和败血症的诊断分析方法的优越性；3)确认在第一阶段工作期间开发的自动化专有计算机软件的可靠性；4)为该分析开发稳定的分析控制产品。5)开发与血液学血细胞计数器集成的第二代检测样机。

DESCRIPTION (provided by applicant): This proposal describes assessment of the clinical utility of a quantitative molecular assay using patented monoclonal antibodies, fluorescence, analytical software, and flow cytometry technology for a white blood cell molecule, called CD64. The expression of CD64 increases rapidly on the blood leukocyte neutrophil subpopulation due to molecular activation of these cells by inflammatory mediators or cytokines. Quantitative measurement of neutrophil CD64 expression with this assay, named Leuko64, can identify the systemic acute inflammatory response occurring in patients with sepsis, infection or tissue injury. The Leuko64 assay is anticipated to have medical utility in the triage of patients with suspected infection to appropriate medical therapy, assist in therapeutic monitoring of patients on antibiotic therapy and thereby reduce the unnecessary use of antibiotics, thus minimizing the pressure for the development of antibiotic resistant organisms. The Leuko64 assay represents one of the first diagnostic assay systems to utilize cellular molecular changes to detect and monitor the immune response to infection and sepsis. The objectives of this proposal are to 1) validate the clinical performance of Leuko64, 2) demonstrate its superiority as a diagnostic assay for detection of infection and sepsis compared to the clinical laboratory tests currently used in contemporary medical practice, 3) confirm the reliability of the automated proprietary computer software developed during the phase I work, 4) develop a stabilized assay control product for the assay, and 5) to develop a prototype second generation assay integrated into a hematology blood cell counter.