Neutrophil CD64 Assay for Human Sepsis and Infection

描述（由申请人提供）：本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称为CD 64的白色血细胞分子进行定量分子测定的临床效用评估。由于炎症介质或细胞因子对血液白细胞中性粒细胞亚群的分子活化，CD64的表达在这些细胞上迅速增加。用这种称为Leuko64的测定定量测量中性粒细胞CD64表达，可以识别脓毒症、感染或组织损伤患者中发生的全身急性炎症反应。预期Leuko64检测试剂盒可用于对疑似感染患者进行适当药物治疗的分类，协助对接受抗生素治疗的患者进行治疗监测，从而减少抗生素的不必要使用，从而最大限度地减少抗生素耐药微生物的发展压力。Leuko64检测试剂盒代表了首批利用细胞分子变化检测和监测感染和脓毒症免疫反应的诊断检测系统之一。本提案的目的是：1）确认Leuko64的临床性能，2）证明其作为检测感染和脓毒症的诊断检测试剂盒与当前医学实践中使用的临床实验室检测试剂盒相比的优效性，3）确认I期工作期间开发的自动化专有计算机软件的可靠性，4）开发稳定的检测试剂盒对照产品，和5）开发集成到血液学血细胞计数器中的原型第二代测定。

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.