CLIENT: CLinic-based Infection Examination through Nucleic acid Technology

性传播感染诊断（STI分析）的范例目前涉及利用通过核酸检测方法（检测病原体的DNA或RNA）实现的灵敏度和特异性。这需要将临床样本发送到远程实验室设施，该实验室设施具有所需的复杂且昂贵的仪器。该领域的理想创新是在患者短暂等待诊断的同时，在一次就诊中实现诊断和治疗（“测试和治疗”）。在CLIENT项目中，我们计划通过实施新颖科学和技术的创新组合来改变这种旧模式，为STI提供简单易用，快速，廉价的床旁（POC）分析系统。该项目将通过汇集4个不同的创造性贡献来实现这一目标，涉及：i）与即将采用的探针探测技术相容的最新荧光颜色化学物质（HyBeacon探针），特别是具有低背景噪声的化学物质，以大大提高阳性临床样本的检测灵敏度。ii）最具适应性的探针技术已经在衣原体的直接采样研究中试用（和淋病）从尿液和拭子在PCR反应，并分别证明其在将要使用的必然更快的单热扩增方法中起作用。一种经验证的廉价台式扩增和荧光检测仪器，与上述HyBeacon探针技术兼容，该技术将进一步发展，以同时分析多种感染因子（多重分析）。iv）一个专门的性病研究和临床部门，目前每年检测数千个样本。该项目的合作者都设在英国，基础技术是在英国发明的，关键的背景知识产权是由该项目的工业合作伙伴拥有的。2工业合作伙伴已经建立或正在进行市场销售。

The paradigm for the diagnosis of sexually transmitted infections (STI analysis) currently involves utilising the sensitivity and specificity achieved through nucleic acid detection methodologies (detecting the DNA or RNA from the pathogen). This requires sending clinical samples to remote laboratory facilities which have the required sophisticated and expensive instrumentation. The ideal innovation in this field is to enable diagnosis and treatment ('test and treat') within a single visit to the clinic whilst the patient briefly waits for the diagnosis. In the CLIENT project we plan to transform this old paradigm by implementing an innovative combination of novel science and technology to deliver a simple to use, rapid, inexpensive, Point-of-Care (POC) analysis system for STIs. The project will achieve this by bringing together 4 different creative contributions involving:i)the latest fluorescent colour chemistries which are compatible with the probe-based detection technology to be deployed (HyBeacon probes), especially chemistries with low background noise to greatly improve detection sensitivity for positive clinical samples.ii) the most adaptable of probe technologies already trialed in direct sampling studies of chlamydia (and gonnorhoea) from urine and swabs in PCR reactions, and separately proven to function in the necessarily faster unithermal amplification methods that will be used.iii) a proven inexpensive desktop amplification and fluorescence detection instrument that is compatible with the above HyBeacon probe technology which will be further developed to analyse multiple infective agents simultaneously (multiplex analysis).iv) an expert STI research and clinical department that is currently testing thousands of samples a year.The collaborators in this project are all based in the UK, the underlying technology was invented in the UK and the key background IP is owned by the industrial partners on this project.The industry partners have sales routes to market already established or in hand.