PRADA (Portable Rapid Automated DNA Analysis)

The rise in bacterial infections affecting mankind shows no sign of abating, with ever increasing cases of sexually transmitted disease, diarrheal illnesses and outbreaks of antibiotic resistant superbugs in our hospitals. To counter the threats posed, and to relieve the escalating burden being placed on health services, it is imperative that the causative agent of infection is rapidly diagnosed. Early diagnosis will allow patients to receive treatment in a more timely manner, thereby reducing suffering and increasing the chances of a successful outcome. More importantly, it will minimise cross contamination and avert the catastrophic consequences of a serious outbreak. The objective of PRADA is, therefore, to enable the rapid detection of the agents responsible for key infectious diseases at the earliest possible moment by developing technology that can be used 'at the bedside' in hospitals, GP surgeries and other point-of-care settings, eg., nursing homes. This will be achieved through the design and development of a portable piece of equipment that can be used to simply and rapidly diagnose the presence of specific infectious organisms through the detection of part of their chromosome / a DNA biomarker. By locating this instrument in a point-of-care-setting, it will remove the need to send samples to a distantly located specialised reference lab. Definitive diagnosis will, therefore, be possible within minutes rather than days. Treatment can begin immediately, and, in hospitals, infection control teams can be alerted to the presence of serious infectious agent at the earliest possible juncture. The project will focus on the development of priority assays for sexually transmitted infections, diarrhoeal diseases and the hospital-acquired infections caused by MRSA and Clostridium difficile. However, the instrument will be capable of performing many other infectious disease tests (human and animal, viruses and bacteria) as well as genetic tests.The system will incorporate technologies that have been pioneered by the commercial partner leading this project, Enigma Diagnostics. This technology has already been proven in the laboratory and the field. A larger, first generation instrument (Enigma FL) has already been trialled with the Ministry of Defence, the Veterinary Laboratory Agencies and the Institute of Animal Health. The instrument development will be led by Enigma Diagnostics using in-house engineering resources, as well as sub-contracting specialist activities to engineering consultants Sagentia for design, proof-of-principle and fabrication. It will be divided into two intricately connected work programmes covering the consumable cartridge, hardware and software. At multiple points through the development, end-users will be consulted to ensure that the system specifications will meet the requirements for performance, ease-of-use, reliability and cost.The assay tests will be designed by specialist research centres at University of Nottingham and Nottingham Trent University. They will use existing knowledge of the clinically important strains of MRSA, Clostridium difficile, Campylobacter, and Salmonella to design the specialised marker DNA sets which will allow the detection of each class of bacteria in clinical specimens using the final PRADA machine. These will be designed on the basis of computer analysis of the complete genomes (genetic blueprints) of each type of bacteria, as well as through experimental approaches. Selected DNA biomarkers will be rigorously tested to ensure that they are capable of detecting all examples of a particular bacterium, and that they do not wrongly incriminate other bacteria. Having established the specificity and selectivity of the biomarkers, they will be incorporated into an assay format appropriate to the Enigma technology and their effectiveness in the new, portable instrument rigorously tested.