Single-use tests: sensitivity and easy use combined for diagnostics

Diagnostic testing usually takes some time and a sterile environment to get the results. To cut down on the costs and effort spend on these tasks there are different diagnostic tests. One of them are single-use tests offered by SensDx S.A. The technology behind them not only makes the process faster and easier, but provides the opportunity to expand into home use in the future as well.

In this MEDICA-tradefair.com interview, Katarzyna Pala talks about the advantages of single-use tests and explains how they can influence diagnostic testing in clinics.

How does your diagnostic testing work?

Katarzyna Pala: We offer diagnostic tests that enable the detection of proteins in a solution. The principle of the method is therefore electrochemical impedance spectroscopy, which is very sensitive, easy to use and fast. The tests are composed oft he reader, single-used tests and application. When we have a virus, in the sample, it is destroyed, releasing proteins and the proteins are caught by molecules on the surface of our single-use test. When the reaction occurs, there are small changes of the impedance in the solution which then are recognized by the reader. The reader is a universal device that connects to the application on the computer or mobile device, that has a machine-learning algorithm to analyze the changes in impedance. These methods behind technology make the test more efficient than usual.

What differentiates your technology from others?

Pala: Our technology is as sensitive as the gold standard already on the market, the Real-Time PCR. However, this method is very expensive and not so easy to use. It requires qualifications to be operated. Moreover, it requires a clean and expensive laboratory. The alternatives are lateral flow tests, that are easy to use and relatively quick but have a poor sensitivity, especially at the early stage of infection. Our test is as sensitive as RT-PCPR, but as easy to use as the lateral flow test. Moreover, we are working on multisensors, which will detect up to 7 pathogens in one swab, which is impossible to do with the lateral flow method and relatively expensive with RT-PCR.

How is it possible to detect pathogens with your technology?

Pala: We have developed sensitive and specific molecules to detect the chosen biomarkers. If the selected pathogens, such as the influenza virus, are present in the solution, the molecules connect with viral or bacterial proteins. The reaction is detectable by the electrochemical impedance spectrometer, which is designed to detect small signals generated by the reaction on the single-use tests.

The product is linked to an app, what data gets collected and with whom is it shared?

Pala: We do not share any data because of the regulations.  With our app we are not collecting personalized data, we are only collecting the data on whether the result is positive or negative. Our target groups are clinics and GP’s and they possess all medical data from our device.

Can everybody use the testing technology?

Pala: Currently we make the test available for professional use only. The market for professional use is there, so we are able to sell the product to doctors, clinics, hospitals and nurses. The methodology is so easy to use that we want to offer the test for home use in the future in various business models. We are also licensing the technology to other areas of applications, for example for veterinary diagnostics. This is a universal platform, which has unlimited possibilities.