Sensitive Detection of Bacterial Contamination in Platelets

描述（由申请方提供）：血小板的细菌污染是输血传播感染发病率和死亡率的主要原因。据估计，血小板的细菌污染率为1/2，000至1/3，000血小板单位。根据监测和其他研究的推断，预计这些输血造成的死亡人数每年从15人到200多人不等。有几种技术方法用于血小板中的细菌检测，但没有一种被广泛接受，因为它们缺乏所需的速度或灵敏度。Lynntech提出了一种创新的，易于操作的，定量的，实时对流PCR（QC-PCR）热循环细菌检测系统（BDS），以实现血小板检测所需的速度和灵敏度接近释放时间。基于QC-PCR的BDS在一小时内提供随机访问的核酸检测，从核酸提取到扩增和实时检测。预计该技术能够检测血小板中的多种细菌，检测限为102至103 CFU/mL（每个PCR反应1至10个基因组拷贝）。由于血小板，特别是合并的随机供体全血衍生血小板，在放行前立即进行处理，因此需要快速细菌检测来检测离散样本。因此，该系统的随机存取核酸分析能力满足了输血服务的关键需求，因为输血服务不同时处理大量血小板。用户无需等待其他PCR反应完成后再运行更多样本。这种创新系统将有助于减少目前与基于培养的方法相关的血小板单位处理和释放的延迟。此外，每次测试只需要200升血小板。这将显著减少基于培养的方法的血小板损失，每种方法需要3至5 mL血小板。简而言之，该系统的实施将大大减少感染和死亡病例的数量，提高患者的生活质量，每年为卫生保健系统节省数百万美元。此外，重要的是系统的简单性，这导致医院和血库购买低成本系统。Lynntech的基于QC-PCR的BDS是下一代分子诊断工具，将使非专业操作员能够在任何环境中以更低的成本以更快的速度进行复杂的生物学测试。QC-PCR技术可适用于运行几乎任何现有和未来基于PCR的临床诊断测定。通过显著简化和加速测试，BDS系统可以允许在医生办公室以及医院以即时护理格式进行分子诊断测试。该系统对资源贫乏的国家也很有用。这项技术为更好地管理每年影响数百万美国人的血小板供应质量提供了机会，特别是通过输注受污染的血小板来预防细菌相关感染和败血症。考虑到市场规模和延长血小板保质期和改善感染预防的相关节省，经济影响也是巨大的。一旦开发出来，该产品还可以扩展用于检测其他血液制品成分中的病原体。此外，该系统将具有巨大的商业潜力和医疗价值，在医生办公室、诊所、医院甚至在资源贫乏的国家提供快速、低成本、易于使用的体外诊断。

DESCRIPTION (provided by applicant): Bacterial contamination of platelets is the leading cause of morbidity and mortality from a transfusion- transmitted infection. Bacterial contamination rates for platelets have been estimated to occur at a frequency of 1 in 2,000 to 1 in 3,000 platelet units. Projected fatalities from these transfusions, based on extrapolation from surveillance and other studies, vary from 15 to over 200 per year. There are several technical approaches for bacterial detection in platelets but none have been widely accepted because they either lack the speed or sensitivity required. Lynntech proposes an innovative, easy-to-operate, quantitative, real-time convective PCR (QC-PCR) thermal cycling bacteria detection system (BDS) to achieve the speed and sensitivity required for platelets testing near the time of release. The QC-PCR based BDS provides random-access nucleic acid testing in one hour, from nucleic acid extraction to amplification and real-time detection. The technology is anticipated to be able to detect a broad range of bacteria in platelets at a detection limit between 102 to 103 CFU per/mL (1 to 10 genomic copies per PCR reaction). Because platelets, especially the pooled random donor whole-blood derived platelets, are processed immediately before release, rapid bacterial detection is needed to test the discrete samples. The system's random-access nucleic acid analysis capability, therefore, meets the critical needs of transfusion services which do not process high numbers of platelets for transfusion simultaneously. Users will not need to wait for completion of other PCR reactions before running more samples. This innovative system will help reduce the delay in processing and release of platelet units that are currently associated with culture based methods. In addition, each test requires only 200 ¿L of platelets. This will significantly reduce the loss of platelets to culture-based methods which each require 3 to 5 mL of platelets. In short, the implementation of the system will significantly reduce the number of cases of infections and fatalities, improving the patients' quality of life and saving the health care system millions of dollars annually. Also, important is the simplicity of the system which leads to low-cost systems for hospitals and blood banks to purchase. Lynntech's QC-PCR based BDS is the next generation of tool for molecular diagnostics that will enable a non-specialized operator to perform sophisticated biological tests in any setting with greater speed at a lower cost. The QC-PCR technology can be adapted to run virtually any existing and future PCR based clinical diagnostic assays. By significantly simplifying and accelerating testing, the BDS system could allow for molecular diagnostic testing at doctors' offices as well as hospitals in point-of-care format. The system will also be great for resource poor countries. This technology provides an opportunity for better management of the quality of platelet supply affecting millions of Americans annually, specifically for preventing bacterial related infections and sepsis through transfusion of contaminated platelets. The economic impact is also enormous considering the market size and associated savings from prolonging platelet shelf life and improving infection prevention. Once developed, the product can also be expanded for use to detect pathogens in other blood product components. Also, the system will have great commercial potential and medical values in providing rapid, low-cost, easy-to-use in- vitro diagnostics in doctors' offices, clinics, hospitals, and even in countries with poor resources.