Rapid Detection of Bacterial Contamination in Platelets

描述(申请人提供)：由于输注受细菌污染的血液成分，特别是血小板而引起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。被细菌污染的血小板和红细胞的发病率分别为2,000-3,000和30,000中有1例，每年导致3,000-4,500例败血症，其中500-750例病情严重，许多人死亡。相比之下，通过输血传播的病毒感染的发病率目前估计在每百万份血液成分中有1至4例，即每年25至100例。 通过使用一种快速、特异、廉价和对多种细菌敏感的有效细菌检测试验，可以最大限度地减少因输注血小板而引起的细菌感染。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志物来开发一种用于这种预期用途的细菌检测测试。MBA技术，当与新型细菌标志物一起使用时，应该可以开发出一种快速、廉价、特异和敏感的细菌检测方法。在这项第一阶段的研究中，Cellex将通过(1)设计和制定一种检测方法，(2)优化检测程序，以及(3)从速度、特异性和灵敏度方面评估检测性能，来验证该技术用于浓缩血小板中细菌检测的可行性。 这项第一阶段研究的成功结果将导致第二阶段研究，该研究将证明该测试在临床环境(例如医院或血库的输血服务)中的表现。第二阶段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.