A fully integrated assay and platform for detecting Clostridium difficile.

描述（由申请方提供）：本拟议项目的主要目标是开发一种用于检测人粪便中艰难梭菌的床旁诊断检测方法和平台。另外两个目标是检测C.艰难梭菌B1/NAP/027;医疗器械拭子中的艰难孢子。C.艰难梭菌相关疾病（CDAD）现在是美国最常见的医疗保健获得性感染，估计每年有300万例CDAD病例，每年花费10 - 32亿美元。C.据估计，在住院时间长达两周的患者中，艰难梭菌感染率为13%，在住院时间超过四周的患者中，艰难梭菌感染率为50% 5。检测C.艰难 将艾滋病病毒/艾滋病信息传送到护理点，将有助于为病人提供更及时的护理，并降低疾病传播的风险。监测表面C. difficile污染是该项目的独特贡献。医院、疗养院和康复机构，无论是在国内还是在全球，都将欢迎能够监测C。艰难梭菌及其孢子，相应地响应感染控制程序，并验证这些变化是否达到了预期的结果。克莱蒙生物解决方案公司（CBio）正在开发一种集成的一次性检测设备和平台，该设备和平台基于我们用于样品制备的专有一次性检测盒PureLyse（R）的组合，该检测盒可以在不到五分钟的时间内机械裂解细胞并提取DNA，并具有快速等温核酸扩增系统，两者都嵌入一次性设备中。该平台提供扩增产物的检测，并基于CBio的便携式FluoriSense荧光计。PureLyse（R）腔室将安装在我们的新型OmniValve内，以创建一种有助于快速有效制造的检测设备。

DESCRIPTION (provided by applicant): The primary goal of this proposed project is to develop a point-of-care diagnostic assay and platform for the detection of Clostridium difficile from human stool. Two additional goals are to detect the hypervirulent strain of C. difficile B1/NAP/027 and to detect C. difficile spores from swabs of medical devices. C. difficile associated disease (CDAD) is now the most common healthcare acquired infection in the United States with an estimated three million CDAD cases per year, costing $1- 3.2 billion per year. The frequency of C. difficile acquisition is estimated to be 13% in patients with hospital stays of up to two weeks, and 50% in those with hospital stays longer than four weeks5. Bringing detection of C. difficile to the point-of-care setting will facilitate more timely treatent for patient, as well as reduce the risk of spread of the disease. The capability to monitor surfaces for C. difficile contamination is a unique contribution of this project. Hospitals, nursin homes, and rehabilitation facilities, both nationally and globally, will welcome the ability to monitor the burden of environmental contamination by C. difficile and its spores, respond with infection control procedures accordingly, and verify that those changes have achieved the desired result. Claremont BioSolutions (CBio) is developing an integrated disposable assay device and platform that is based on the combination of our proprietary disposable cartridge for sample preparation, PureLyse(R), that can mechanically lyse cells and extract DNA in less than five minutes, with a rapid isothermal nucleic acid amplification system, both embedded into a disposable device. The platform provides detection of the amplification product and is based on CBio's portable FluoriSense" fluorometer. The PureLyse(R) chamber will be mounted within our novel OmniValve" to create an assay device that lends itself to rapid and efficient manufacturing.