Rapid Detection of Bacterial Contamination in Platelets

描述（由申请方提供）：因输注细菌污染的血液成分（特别是血小板）而导致的败血症是一种持续的医学问题，经常导致死亡或严重发病。细菌污染的血小板和红细胞的发生率分别为1/2，000至3，000和1/30，000，每年导致3，000 - 4，500例败血症，其中500-750例严重，许多是致命的。相比之下，输血传播病毒感染的发病率目前估计为每百万血液成分1至4例，或每年25-100例。 血小板输注引起的细菌感染可以通过使用有效的细菌检测试验来最小化，该试验对多种细菌种类快速、特异、廉价和敏感。目前还没有满足这些要求的测试。我们建议使用我们的基于微粒的扩增（MBA）技术和一类新的细菌标记物来开发用于此类预期用途的细菌检测试验。MBA技术，当与新型细菌标记物一起使用时，应允许开发快速，廉价，特异性和敏感性的细菌测试。在这项I期研究中，Cellex将通过（1）设计和制定检测方法，（2）优化检测方案，（3）评价检测方法在速度、特异性和灵敏度方面的性能，验证该技术用于血小板浓缩物中细菌检测的可行性。 该I期研究的成功结果将导致II期研究，该研究将证明该测试在临床环境中的性能（例如，医院或血库的输血服务）。II期研究的成功结果将导致该测试的商业化，这将有助于提高我国血液供应的安全性。

DESCRIPTION (provided by applicant): Sepsis resulted from transfusion of bacterially contaminated blood components, particularly platelets, is an on-going medical problem that frequently causes mortality or serious morbidity. The incidence of bacterially contaminated platelets and red cells is 1 in 2,000 to 3,000, and 1 in 30,000, respectively, resulting in 3,000- 4,500 sepsis cases yearly, of which 500-750 cases are severe and many are fatal. In contrast, the incidence of transfusion-transmitted viral infections is currently estimated to be between 1 and 4 per million blood components, or 25-100 cases a year. Bacterial infection due to platelet transfusion can be minimized with the use of an effective bacterial detection test that is rapid, specific, inexpensive and sensitive for multiple bacterial species. A test that meets these requirements is currently not available. We propose to use our microparticle based amplification (MBA) technology and a novel class of bacterial markers to develop a bacterial detection test for such intended use. The MBA technology, when employed with the novel class of bacterial markers, should permit the development of a rapid, inexpensive, specific and sensitive bacterial test. In this Phase I study, Cellex will verify the feasibility of the technology for use in bacterial detection in platelet concentrates by (1) designing and formulating an assay, (2) optimizing the assay protocol, and (3) evaluating the assay performance in terms of speed, specificity and sensitivity. A successful outcome of this Phase I study will lead to a Phase II study, which will demonstrate the performance of the test in clinical settings (e.g., transfusion services in hospitals or blood banks). The successful outcome of Phase II study will lead to the commercialization of the test, which will contribute to the improvement of safety of our nation's blood supply.