Three UK organisations have entered into a strategic alliance to develop a hand-held system to detect the hospital superbugs, C.difficile and MRSA.
Universal Sensors and Cambridge Design Partnership, of Cambridge, and Nottingham Trent University are working to create an environmental testing device to ensure that an area decontaminated by cleaning after an outbreak is really free from live bacteria or C.difficile spores.
The result will be a new a highly sensitive biosensor-based product that can detect pathogens in five minutes, compared with traditional tests that have to be performed in a specialised laboratory and can take 2-3 days to get the results back to the infection control team.
The collaboration is funded through the new Small Business Research Initiative (SBRI), in contracts that were awarded by the National Institute for Health Research (NIHR) under its Invention for Innovation (i4i) Programme.
The control of Health Care Associated Infections (HCAIs) and improving the cleanliness of hospitals are primary objectives for the UK's National Health Service (NHS). In 2008, the NHS spent £53m undertaking a comprehensive “deep clean” of every hospital in the UK, but unil now there has been no quick and simple environmental tests available to verify that an area has been completely decontaminated by cleaning after an outbreak.
“The impact that this new product could have on HCAI control is significant,” said Dr Graham Cooley, ceo of Universal Sensors. “It will allow the Infection Control Team to know within five minutes whether an area is safe for a patient to occupy and it can be used by workers who do not possess specialist training.”
The collaboration was assembled by Cambridge Design Partnership who had worked with Universal Sensors in the development of the manufacturing technique for their unique sensors. Cambridge Design Partnership's hand-held platform is a powerful but low cost microprocessor-based technology, developed by the company over several years. Re-applying this platform technology for use with the Universal Sensor detection system allowed the creation of a new mobile device for performing immunoassays and tests for DNA from pathogenic organisms.
This platform will be developed to comply with the applicable EU directives for medical devices (In Vitro Diagnostic Medical Devices Directive 98/79/EC) and FDA requirements for a Class II Medical Devices in the USA (market clearance by 510(k) premarket notification) as well as being CE marked and UL approved as a laboratory instrument.
“The development of a mobile test platform is an important corner stone of this collaboration,” commented Dr Duncan Purvis, CSO of Universal Sensors, “but we also needed leading research scientists who could develop tests for HCAIs and we are delighted that Dr Alan McNally of Nottingham Trent University agreed to collaborate with us.
“New tests developed by Dr McNally will be integrated into our mobile product platform which is called eLISA (electronically linked immunosorbent assay).”
According to Dr McNally, the speed, sensitivity and flexibility of the Universal Sensor technology means that it can be applied to a range of different assays as well as for MRSA and C.difficile. The development programmes of this project are to be undertaken in two phases. The consortium expects to complete this first phase within six months and intends to take the eLISA system into production by the end of 2010.
Contact Universal Sensors Ltd T +44 1799 531144 www.universalsensors.co.uk
Nottingham Trent University T +44 115 848 3324 www.ntu.ac.uk
Cambridge Design Partnership T +44 1223 264 428 www.cambridge-design.co.uk