The project aims to develop an innovative diagnostic technology for the quick detection of the SARS-CoV-2 virus in biological samples. Special cassettes with electrochemical sensors will be used for testing. 

“Tests to detect antigens and antibodies are already available in the market, but molecular diagnostics has so far been done mainly in labs, using real-time PCR devices. We want to miniaturize that technology,” says Professor Elżbieta Malinowska, who is in charge of the work carried out by the WUT team.

An innovative approach

The innovative nature of the project mainly consists in the universal applicability of the newly developed technology. “We want to design three different biosensor cassettes and use a single micro-electronic reader for all of them. In this way, depending on the needs and recommendations, we will be able to get the right information about a specific patient,” explains Professor Mariusz Pietrzak of the WUT Faculty of Chemistry.

What information will we get? The first cassette will detect virus proteins which can be found on its surface. It will be fitted with the right receptors to “track” it.

The second type will detect antibodies against the virus. It will let us know if a patient has already been infected (or is asymptomatic) and already has antibodies.

The third cassette will allow us to detect the right genetic sequences to indicate that the virus we are looking for is in fact present in the sample.

In all of those cases, the waiting time for the result will be very short. It will take roughly half an hour to detect the virus using the cassettes, rather than 8-10 hours as is the case with classic lab tests.

Quantity on a par with quality

As emphasized by dr inż. Kamil Żukowski of CEZAMAT, the project team is building the entire system, from sampling to the final result. “Right from the start, we have been designing the cassettes to optimize their subsequent manufacturing. We use cheap and readily available materials and technologies which assure very high manufacturing efficiency, as we will need to produce a lot of cassettes in a short time,” the investigator says.

A single reader is expected to work with numerous cassettes, which should be as cheap as possible. Currently, besides PCR tests, antigen cassette tests are already available, with prices in the range of PLN 25-50. The WUT team does not want to lower that price level at all cost, but expects its solution to be equally affordable.

ImGen system visualization, photo: Kamil Żukowski

“Even if the price is not very competitive, our solution will still have an edge over others. This will be due to its availability and the reliability of the analyses,” emphasizes Professor Elżbieta Malinowska. Thanks to a portable device in which the cassettes will be fitted, it will be easier to conduct the tests in many places, such as walk-in clinics or nursing homes. Correct sampling will be a necessary precondition for an accurate result – it will require specialist personnel, although the test itself and the operation of the device should be easy enough for people with no specialist training to manage.

A correctly collected uncontaminated sample is a precondition for a reliable analysis. Subsequently, the success of the test will be determined by the solutions proposed by WUT researchers. Their task is to develop tests with the highest possible medical sensitivity. On the one hand, they are tapping into knowledge about optic antigen tests, which are less accurate, while on the other, they are using their own experience related to electrochemical analyses. Research into classic and miniature devices for the measurement of substances of clinical significance has been conducted for years at the WUT Faculty of Chemistry, Chair for Medical Biotechnology.

Futureproof solutions

The system developed by Professor Malinowska’s team has been created with more in mind than just SARS-CoV-2 diagnostics. The design assumptions are universal enough to be modified and applied in the future, if it becomes necessary to fight a different pathogen. As emphasized by dr inż. Robert Ziółkowski of the WUT Faculty of Chemistry, in order to do this, we first need to get to know our “enemy” and its structure. We need to study the genetic sequence characteristic of a particular pathogen, which we will detect in the sample. For SARS-CoV-2, three different sequences characteristic of that particular coronavirus will be detected.

The project entitled: “Development of the structural design and manufacturing technology of miniature diagnostic devices for rapid POCT detection of SARS-CoV-2 virus in biological samples” is funded by the Smart Growth Operational Programme.

The project consortium consists of ScreenMed, Warsaw University of Technology (CEZAMAT and the Faculty of Chemistry) and the National Public Health Institute – National Institute of Hygiene