RAPID METHOD FOR BACTERIAL SCREENING OF DONATED BLOOD

输血制品的细菌污染是公认的败血症的来源，并且仍然是血库和输血服务人员严重关注的问题。尽管存在这些问题，但目前还没有广泛接受的、实用的和可靠的方法来对库血进行常规筛查。潜在有害的细菌污染水平。这种方法的发展将大大降低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(PSI)建议与达特茅斯-希区柯克医学中心合作开发一种快速、非侵入性、非接触性的方法，用于常规筛查库存全血和红细胞（RBC）的潜在危险水平的细菌污染。所提出的方法将采用基于可见光/近红外反射光谱的方法，直接监测袋装产品（无需抽取血液等分试样）的有害细菌生长水平。第一阶段调查将包括原理验证可行性研究。随后的第二阶段工作的目标是设计和建立一个临床原型血液制品筛选仪器，并在合格的献血中心和实验室广泛测试其灵敏度和特异性。拟议的商业应用：一种快速、可靠和广泛接受的方法，在输血前对捐献的全血和红细胞进行常规筛查，以防止有害细菌污染，这将对国家血液供应的安全做出重要贡献。一旦证明是可靠和具有成本效益的，拟议的方法和相关仪器应具有巨大的商业潜力。

Bacterial contamination of transfused blood products is a well-recognized source of sepsis and remains a serious concern to blood bank and transfusion service 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 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. (PSI) proposes to develop, in conjunction with the Dartmouth-Hitchcock Medical Center, a rapid, non-intrusive, non-contact method for routinely screening banked whole blood and red blood cells (RBC's) for potentially dangerous levels of bacterial contamination. The proposed approach will employ a method based on visible/NIR reflectance spectroscopy to directly monitor the bagged product (no aliquots of the blood need be withdrawn) for harmful levels of bacterial growth. Phase I investigations will consist of proof-of-principle feasibility studies. The aim of a subsequent Phase II effort would be to design and build a clinical prototype blood product screening instrument and to extensively test its sensitivity and specificity at a qualified blood donation center and laboratory. PROPOSED COMMERCIAL APPLICATIONS: A rapid, reliable and widely accepted method to routinely screen donated whole blood and RBC's for hazardous bacterial contamination prior to its 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.