CLIENT: CLinic-based Infection Examination through Nucleic acid Technology

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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.