Microwave-Accelerated Metal Enhanced Fluorescence (MAMEF) of CT and GC

 描述（由申请人提供）：在过去的几年中，马里兰州巴尔的摩县大学的荧光研究所（IoF）开发了一项基础技术，该技术有可能深刻改变床旁检测和随后的特定人类健康疾病。我们对微波加速金属增强荧光技术（MAMEF）的研究，当应用于RNA靶检测传感平台、沙门氏菌血清型靶、生物剂靶（如炭疽芽孢杆菌和性传播感染（STI））时，提供了相当于PCR水平的灵敏度，但没有任何热循环扩增步骤，检测低至1cfu/ml的细菌靶 在20秒内。MAMEF技术不仅看起来将与PCR扩增方法进行激烈竞争，而且我们迄今为止开发的结合速度，灵敏度和前期样品制备步骤使该技术能够在护理点（POC）设置中得到认真考虑，其中样品制备和目标检测可以在1分钟内显着实现。据我们所知，目前还没有其他已发表的技术能够同时提供速度、灵敏度、低成本和易于应用于众多临床目标的能力。在过去的5年中，荧光研究所被邀请参加我们的快速和灵敏的MAMEF技术的试验研究，与美国国立卫生研究院（NIBIB）POCTRN组。NIBIB创建了国家护理点技术研究网络（POCTRN），通过将科学和技术能力与临床需求相结合的合作来推动选定技术的开发。的 该网络由4个世界知名的中心组成，这些中心遍布美国，每个中心都有一个单独的研究和医疗保健提供主题。基于MAMEF技术的一个非常成功的评估阶段，NIBIB继续通过其中一个中心资助MAMEF技术用于检测性传播感染;这是约翰霍普金斯大学U 54 STI中心赠款的一个子项目，U 54 EB 007958，由世界著名的性传播感染研究人员夏洛特盖多斯博士领导。虽然U 54中心的赠款资助了实际技术本身的开发，但测试阶段有限，资金无法用于大规模的前瞻性研究和临床验证。随后，该R 03提案特别关注在U 54中心资助下开发的MAMEF CT和GC检测试剂盒的盲态临床验证，在2年内使用1800例女性患者。MAMEF技术在临床环境中成功验证的重要性怎么强调都不过分。MAMEF技术有可能直接影响STI测试和医疗保健。

 DESCRIPTION (provided by applicant): Over the last several years the Institute of Fluorescence (IoF) at the University of Maryland Baltimore County has developed a fundamental technology which has the potential to profoundly change Point-of-Care testing and subsequently specific Human Health diseases. Our studies of the Microwave-Accelerated Metal-Enhanced Fluorescence technology (MAMEF), when applied to RNA- target assay sensing platforms, Salmonella Serovar targets, Bioagent targets such as Bacillus Anthraces and sexually transmitted Infections (STI's), is providing for the equivalent of PCR-level sensitivity, but without any thermal cyclic amplification steps, detecting as low as 1cfu/ml of bacterial target within 20 seconds. Not only does the MAMEF technology look set to seriously compete with PCR amplification approaches, but the combined speed, sensitivity and upfront sample preparation steps which we have developed to date, are allowing the technology to be seriously considered in Point-of-Care (POC) settings, where both sample preparation and target detection can be remarkably achieved within 1 minute. To the best of our knowledge, there is no other published technology which offers both the combined speed, sensitivity, low cost and the ability to be readily applied to numerous clinical targets. During the last 5 years, the Institute of Fluorescence was invited to participate in a trial study of our rapid and sensitive MAMEF technology, with the NIH's (NIBIB) POCTRN group. NIBIB created the national Point-of-Care Technologies Research Network (POCTRN) to drive the development of selected technologies through collaborations that merge scientific and technological capabilities with clinical need. The network was comprised of 4 world renowned centers, which span the USA, each with an individual research and health care delivery theme. Based on a highly successful evaluation phase of the MAMEF technology, NIBIB has continued to fund the MAMEF technology for the detection of STI's (Sexually Transmitted Infections) through one of these centers; a subaward from a Johns Hopkins University U54 STI Center grant, U54 EB007958, headed by Dr Charlotte Gaydos, a world renown STI researcher. While the U54 center grant has funded the development of the actual technology itself, with a limited testing phase, the funds are not available for a large scale prospective study and clinical validation. Subsequently, this R03 proposal is specifically focused at blindly clinically validating the MAMEF CT and GC assays developed under the U54 center grant, with 1800 female patients, over a 2 year period. The significance of a successful validation of the MAMEF technology in a clinical setting cannot be over stated. The MAMEF technology has the potential to directly impact STI testing and health care.