Neutrophil CD64 Assay for Human Sepsis and Infection

描述（由申请人提供）：本提案描述了可行性 使用单克隆抗体的定量分子测定的测试， 荧光和流式细胞术技术用于白色血细胞分子， 叫0064 CD64在血白细胞上的表达迅速增加 由于炎症介质的分子活化导致的中性粒细胞亚群 或细胞因子。中性粒细胞cD64表达的定量测量可以 确定发生全身性急性炎症反应的患者， 败血症、感染或组织损伤。预计CD64测定具有 在将感染患者分诊至适当医疗 治疗，协助对接受抗生素治疗的患者进行治疗监测， 减少不必要的抗生素使用，从而减少 抗生素抗性生物体。目标是优化专利的使用 0064测定中的单克隆抗体，确定测定制剂 商业化，验证制造程序，提高精度和 检测的灵敏度，证实了一种新的定量方法的实用性， 中性粒细胞cd64表达采用流式细胞术，开发专有计算机 软件，以提高测定精度，证明稳定的 试验对照品，并为后续II期试验准备试验设计 临床试验，以证明与当前临床试验相比的优效性 败血症、感染和急性炎症性疾病的实验室检查。

DESCRIPTION (provided by applicant): This proposal describes feasibility testing of a quantitative molecular assay using monoclonal antibody, fluorescence, and flow cytometry technology for a white blood cell molecule, called 0064. The expression of CD64 increases rapidly on the blood leukocyte neutrophil subpopulation due to molecular activation by inflammatory mediators or cytokines. Quantitative measurement of neutrophil cD64 expression can identify patients with the systemic acute inflammatory response occurring in sepsis, infection or tissue injury. The CD64 assay is anticipated to have medical utility in the triage of patients with infection to appropriate medical therapy, assist in therapeutic monitoring of patients on antibiotic therapy, reduce the unnecessary use of antibiotics, thus minimizing the incidence of antibiotic resistant organisms. The objectives are to optimize use of patented monoclonal antibodies in a 0064 assay, define formulation for assay commercialization, validate manufacturing procedures, improve precision and sensitivity of the assay, confirm utility of a novel quantitative approach to neutrophil cd64 expression using flow cytometry, develop proprietary computer software to improve assay precision, demonstrate feasibility for an stabilized assay control product, and prepare the assay design for subsequent Phase II clinical trials to demonstrate superiority compared to current clinical laboratory tests for sepsis, infection and acute inflammatory diseases.