Sensitive Detection of Bacteria Contaminated Platelets

描述（由申请方提供）：血小板细菌污染是输血传播感染发病和死亡的主要原因。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。接受细菌污染的血小板的风险比HIV、B和C型肝炎以及人类T细胞白血病（HTLV I/II）病毒的输血相关感染的综合风险高50至250倍。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。.它们要么检测代谢底物/产物，细胞的标记物，要么检测细菌本身。虽然基于扩增技术的分子测试允许更好的灵敏度，但它们要昂贵得多，并且通常需要特殊的人员和设备。此外，它们还经常出现假阳性。 Lynntech提出了一种超灵敏和快速的方法来检测血小板中细菌污染的存在。该方法可在血小板释放用于输注的时间附近使用。该方法使用电化学来确认细菌的存在。如果电化学结果高于阈值，则表明需要丢弃血小板产品。该技术不需要核酸扩增或长的孵育期。整个过程将在30分钟内完成，并且可以完全自动化，以减少污染和劳动力成本。该技术预计能够检测102至103 CFU/ml的细菌。简而言之，这种快速可靠的检测方法可以在向患者发放血小板浓缩液之前使用。这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。快速响应时间和高通量检测的潜力不仅可以降低分析成本，还可以显著减少感染和死亡病例的数量，提高患者的生活质量，每年为医疗保健系统节省数百万美元。

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. The risk of receiving a bacterially contaminated platelet is 50 to 250 times higher than the combined risk of transfusion-related infections from HIV, hepatitis B and C, and human T cell leukemia (HTLV I/II) viruses. There are several technical approaches for bacterial detection in platelets but none have been widely accepted. . They either detect the metabolic substrates/products, the cell's marker, or the bacteria itself. Although molecular tests based on amplification techniques allow better sensitivity, but they are far more expensive and usually require special personnel and equipment. In addition, they are subject to frequent false positive. Lynntech proposes an ultra-sensitive and fast method to detect the presence of bacterial contamination in platelets. This method can be used near the time of platelet being released for transfusion. The method uses electrochemistry to confirm the presence of bacteria. If the electrochemical result is above a threshold value, it signals the need to discard the platelet product. This technology does not require nucleic acid amplification or long incubation periods. The process will take less than 30 min to complete, and it can be fully automated to reduce contamination and labor cost. The technology is anticipated to be able to detect bacteria at a level between 102 to 103 CFU per/ml. In short, this quick and reliable testing method can be used just before a platelet concentrate is issued to a patient. This will help reduce the delay in processing and release of platelet units that are currently associated with culture based methods. Fast response time and the potential for high throughput testing will not only lower the cost of analysis but also significantly reduce the number of cases of infections and fatalities, improving the patients' quality of lives and saving the health care system millions of dollars annually.