Neutrophil CD64 Assay for Human Sepsis and Infection

描述(由申请人提供)：这项提案描述了对一种名为CD64的白细胞分子使用专利单抗、荧光、分析软件和流式细胞术技术进行定量分子分析的临床实用性的评估。由于炎症介质或细胞因子对中性粒细胞亚群的分子激活，CD64在血白细胞亚群上的表达迅速增加。用这种名为Leuko64的方法定量测定中性粒细胞CD64的表达，可以确定脓毒症、感染或组织损伤患者发生的全身急性炎症反应。Leuko64检测预计将在对疑似感染患者进行适当医疗分流方面具有医疗效用，有助于对抗生素治疗患者的治疗监测，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微生物的发展压力。Leuko64检测是首批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。该建议的目标是1)验证Leuko64的临床性能，2)展示其作为感染和脓毒症诊断分析与现代医疗实践中当前使用的临床实验室测试相比的优越性，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检测控制产品，以及5)开发集成到血细胞计数器中的第二代检测原型。

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.