At a time when mass testing for the novel coronavirus is becoming extremely important for controlling the pandemic, a Greek research team has created a formidable “pocket lab” that can accurately detect the SARS-CoV-2 virus on the spot, anywhere in the world, in less than 30 minutes.
IRIS was developed by the Biosensor Laboratory of the Foundation for Research & Technology (FORTH) and the University of Crete, and is in the final stage of certification so that it can be mass-produced. The device that performs the analysis is a hand-size box measuring 10x10x11 cm, is based on state-of-the-art technology and is characterized by portability, usability, accuracy and economy.
So how does it work? Samples of saliva or tissue are taken from the person being tested and placed in a small, plastic container with the required reagents. The container is placed in the appropriate position inside the device and the reagents selectively multiply the genetic material of the pathogen or the genetic target that the user is trying to detect. A microcamera records the results by performing a colorimetric analysis (as the colors in the containers change depending on the findings) and, through a wireless connection and software designed by the Greek research team, they are transferred to a mobile phone or tablet. It is that simple and convenient. It is also worth noting that the device was made with a 3D printer by the research team itself, which means it can be re-created quickly and at a very low cost.
“The diagnosis is made by detecting the genetic material of the virus, as is the case with the classic molecular test, the PCR. However, we use another polymerase, Bst, whose reaction is isothermal – that is, no temperature changes are required. That is why our system is very flexible and can be adapted to non-laboratory conditions,” says Dr Electra Gizeli, professor at the Department of Biology of the University of Crete and head of the Biosensor Laboratory of the Institute of Molecular Biology and Biotechnology (IMBB).
“We combine the accuracy of a PCR molecular test with the speed and low cost of a rapid test,” she adds.
This was also demonstrated by the first verification results, as 38 positive and 51 negative samples were re-examined which had previously been tested for Covid-19 at the Pasteur Hellenic Institute. The verification found 100% specialization and 97.4% sensitivity, which are percentages of high accuracy, equal to or better than the respective commercial tests.
After certification, the IRIS device will be able to test simultaneously for coronavirus and influenza. It could be used in places where there is an urgent need for numerous, fast, cheap and – most importantly – reliable molecular tests: workplaces, schools, national borders, remote medical centers without access to laboratories, and mobile control units, among others.
All this research, of course, took time. “When the epidemic broke out, the device and the corresponding method of identifying genetic material were already complete, the result of many years of work,” Dr Gizeli says. “During the lockdown and while working on the detection of influenza and HIV, we immediately switched to the need for rapid detection of Covid-19.”
When the researchers saw after the verification process that the method worked very well, the team started intensive efforts to use it for Covid. “When the EU requested proposals for tackling the pandemic in June, we submitted one which was selected, along with 22 others Europe-wide, from [a total of] 454 submitted. There was funding of 2.4 million euros, mainly to complete the certification process within a few months,” she explains.
IRIS is the result of many years of research. “We started in 2010 with basic research in the fields of biosensors, micro/nanotechnology and molecular diagnosis. From the beginning, we were interested in being active and contributing to the development of microsystems that will allow clinical analyses to be performed outside laboratories and hospitals, close to the patient, so that people living in decentralized areas can have equally good healthcare,” Dr Gizeli says.
Researchers at the Biosensor Laboratory, together with the BioPix-T team, share a vision for global health. “We want to offer technology and solutions affordable to developing countries where there is no extensive healthcare system and the people are poorer,” the biology professor explains. “We work with the logic of global diagnosis, we are interested in making our method available to those who need it in every corner of the Earth. We are working very consciously toward this goal.”
IRIS can be used to detect other infectious diseases as well, such as hepatitis, respiratory infections, and even cancer cell mutations.
A strong interdisciplinary research team was put together to create the pioneering device, combining specialists in the fields of biology (Dr George Papadakis), microtechnology/physics (Dr Alexandros Pantazis) and electrical and computer science (Nikolaos Fikas). This was the only way that the precise biological laboratory tests could be turned into a “box” that could travel effectively where needed.
The coordinator of the new European program is FORTH. BioPix-T (a FORTH startup) is also participating by building and utilizing IRIS. The consortium further includes three hospitals from Britain, France and Belgium that will participate in clinical trials, a certification company (PKNM, Switzerland), an enzyme biotechnology company (EnzyQuest, Greece) and a company from South Africa, which intends to distribute IRIS in sub-Saharan Africa.