IK4 Technological Alliance has designed a low-cost, rapid diagnostic device for detecting the presence of Salmonella spp. and other bacteria in less than one hour, a much shorter time than current systems. Unlike others, this project used clinical samples directly, without prior treatment in a laboratory.
The new diagnostic device is effectively a miniature conventional laboratory inside a chip (Lab on a Chip). Moreover, it is highly specific, rapid, portable and user-friendly. In this way, an ample range of possible users -hospitals, health centres and the food industry, amongst others – have available a device equipped with an optical reading system (fluorescence signal emitted during Polymerase Chain Reaction (PCR) reaction in real time), that enables the rapid identification of pathogens. Within the Chip the system integrates the concentrating of the sample, the rupture of its membrane, the enzymatic multiplication of its DNA and finally identification of the pathogen. The user only has to insert two syringes into the device and the analysis is undertaken automatically.
This research is within the remit of the European OPTOLABCARD project, launched in September 2005 and now about to finish. The project is led by Ikerlan-IK4 and financed by the VI Framework Programme, with an overall budget of 2.9 million euros, and involving the participation of a total of 9 different bodies – DTU-Nano, the Hospital de Donosti through the BIOEF Foundation and Gaiker-IK4 itself, amongst them – and from 6 different countries (Germany, Austria, Denmark, Spain, Poland and Sweden).
Gaiker-IK4’s participation in the project has focused on the adaptation of biochemical developments to the microfluid system of the chip, as well as the optimisation and characterisation of the device for its clinical application and its diagnosis for the presence of Salmonella spp. in persons with colitis. Ikerlan-IK4 has also worked on the development of manufacturing technology for the production of the Laboratory on a Chip. This advance will enable the development of a great variety of new devices in the future.
The OPTOLABCARD project is currently in its final stage, having developed and patented exclusive technology for Micromanufacture and Molecular Diagnosis. The convergence of these two technologies together with the biological results mentioned corroborate the healthy position of IK4 Technological Alliance and is a great opportunity for the development of various and future laboratories miniaturised on a Chip.
Applications of the new device
Although there are many possible applications for the new device, research in this project has focused on two applications differentiated by the type of samples and the pathogen for detection: the detection of campylobacteriosis in farm animals (animal health application) and the identification of salmonellosis amongst persons (human health application). The final stage of the project involved the validation of the device for these types of samples.
One of the great advantages of this device is the rapidity of the whole process of analysis, including the concentrating and preparation of the sample and the detection of pathogens by PCR, in comparison to the procedures habitually employed in laboratories of reference. Likewise, the device’s easy-to-use handling and portability will enable a diagnostic analysis in the doctor’s surgery itself.
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