Methods for Routine Bacterial Screening of Donated Blood

描述（由申请人提供）：输血的细菌污染 血液制品是公认的脓毒症的来源， 关心血库和输血中心人员。尽管存在这些担忧 目前还没有广泛接受的、实用的和可靠的方法 定期筛查库存血液中潜在有害水平的细菌 污染.这种方法的发展将大大减少 由于输血引起的细菌性败血症的风险，并进一步确保 国家血液供应的整体安全。物理科学公司建议， 与我们的研发合作伙伴一起，开发和展示两个 库存血液制品的快速和常规筛选方法 (i.e.,红细胞和血小板）的潜在危险水平， 细菌污染。 拟议的独立但可能是互补的办法已经 被证明是可行，需要：1）一种基于可见/NIR光谱的方法， 直接监测袋装产品（不需要 撤回）的有害水平的细菌生长，和2）一个自动 一种基于落射荧光显微镜的技术， 细菌的产品。 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， 它们用于细菌检测的灵敏度、特异性和易用性 血细胞（RBC）和血小板。 拟定商业应用： 一种快速、可靠和广泛接受的常规筛查捐献血液制品的方法 在输血前进行潜在危险的细菌污染， 为国家血液供应安全做出了重要贡献。 一旦被证明是 可靠和具有成本效益，建议的方法和相关仪器应 具有巨大的商业潜力。 血小板的有效使用点细菌检测 还可以使血小板的保存期从5天延长到7天，从而增加国家的 血小板供应急剧增加。

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1) a method based on visible/NIR spectroscopy to directly monitor the bagged product (no aliquots of the blood need be withdrawn) for harmful levels of bacterial growth, and 2) an automated epifluorescence microscopy-based technique to assay a small sample of the blood product for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.