Methods for Routine Bacterial Screening of Donated Blood

描述(申请人提供)：输液的细菌污染 血液制品是公认的败血症的来源，并且仍然是一个严重的 关注血库和输血中心工作人员。尽管存在这些担忧 目前还没有被广泛接受的、实用的和可靠的方法 例行筛查银行血液中可能有害的细菌含量 污染。这种方法的发展(S)将大大减少 因输血而导致细菌败血症的风险，并进一步确保 国家血液供应的总体安全。物理科学公司提出， 与我们的研发合作者一起，开发和演示两个 库血产品的快速和常规筛查方法 (即，红血球和血小板)的潜在危险水平 细菌污染。 拟议的独立但可能互补的方法已经 证明是可行的，需要：1)一种基于可见光/近红外光谱的方法 直接监测袋装产品(不需要等量血液 撤回)有害的细菌生长水平，以及2)自动 基于荧光显微镜的一小部分血液样本分析技术 细菌产品。 第二阶段的工作将设计和开发临床原型血液产品 筛选基于这些技术的仪器，并对其进行广泛测试 它们对红色细菌检测的敏感性、特异性和易用性 血细胞(RBC)和血小板。 建议的商业应用： 一种快速、可靠、被广泛接受的献血产品常规筛查方法(S) 因为在输血之前有潜在危险的细菌污染会使 为保障国家血液供应安全作出了重要贡献。一旦被证明是 为了可靠和具有成本效益，拟议的方法和相关的工具应 具有巨大的商业潜力。有效的血小板使用点细菌检测 还可以使血小板的保质期从5天延长到7天，从而增加国家的 极大地增加了血小板供应。

DESCRIPTION (provided by applicant): Bacterial contamination of transfused blood products is a well-recognized source of sepsis and remains a serious concern to blood bank and transfusion center personnel. Despite these concerns there currently exists no widely accepted, practical and reliable method for routinely screening banked blood for potentially harmful levels of bacterial contamination. The development of such a method(s) would greatly reduce the risk of bacterial sepsis due to blood transfusions and further ensure the overall safety of the nation's blood supply. Physical Sciences Inc. proposes, in conjunction with our R&D collaborators, to develop and demonstrate two methodologies for the rapid and routine screening of banked blood products (i.e., red blood cells and platelets) for potentially dangerous levels of bacterial contamination. The proposed independent, but potentially complementary, approaches, already shown to be feasible, entail: 1) a method based on visible/NIR spectroscopy to directly monitor the bagged product (no aliquots of the blood need be withdrawn) for harmful levels of bacterial growth, and 2) an automated epifluorescence microscopy-based technique to assay a small sample of the blood product for bacteria. The Phase II effort will design and develop clinical prototype blood product screening instruments based on these technologies and extensively test them for their sensitivity, specificity and ease of use for bacterial detection in red blood cells (RBC's) and platelets. PROPOSED COMMERCIAL APPLICATION: A rapid, reliable and widely accepted method(s) to routinely screen donated blood products for potentially hazardous bacterial contamination prior to their transfusion would make an important contribution to the safety of the nation's blood supply. Once demonstrated to be reliable and cost-effective, the proposed methodology and associated instrumentation should have significant commercial potential. Effective point-of --use bacterial testing of platelets may also allow platelet shelf life to be extended from 5 to 7 days, thus increasing nation's platelet supply dramatically.