The first diagnostic test for COVID-19 and influenza A / B, giving a reliable result in 6 minutes, is launched by the Polish company SensDx. A quick test detects the presence of the virus in a patient even at a very early stage of the infection with sensitivity at the level of a genetic test. This method can contribute effectively to pandemic control.
Access to a rapid and reliable coronavirus test result is critical to a pandemic control strategy. At the moment, results of highly reliable genetic tests are available within 1-3 days. Popular IgG IgM serological tests identify SARS-CoV-2 antibodies only, which in practice means that this method neither confirms nor excludes coronavirus infection.
With the outbreak of the pandemic, the Polish company SensDX S.A. began work on the development of a rapid SARS-CoV-2 test detecting the presence of the pathogen even at a very early stage of infection, with the sensitivity and specificity at the level of the RT-PCR (genetic) test. The Jagiellonian University was involved in the development of SARS-CoV-2 detection. The team of prof. Krzysztof Pyrć from the Małopolska Center of Biotechnology defined a specific and most conservative protein of the SARS-CoV-2 virus for further detection using SensDx technology. As part of the development of the SARS-CoV-2 test, support in the area of biotechnology was provided by the Institute of Biotechnology and Molecular Medicine. In just a few weeks, the quick and reliable test for COVID-19 and influenza A / B will be available to Polish patients.
The SensDx test is intended for use outside the laboratory and will allow for quick diagnosis of patients, e.g. at airports, in emergency medical services, in clinics, pharmacies or drive-thru points. By enabling quick and effective identification of infection, the SensDx solution can help to gain control over the epidemic. The aim of SensDx was to introduce the solution to the market before the announced second wave of the epidemic and to enable the diagnosis of coronavirus and influenza A / B virus with one swab. This is extremely important because experts believe that the second wave of COVID-19 cases will coincide with the next flu season.
The SensDx test checks for the presence of active viral protein and will not give a false-positive result in the presence of residual inactive virus RNA, which is a key factor differentiating SensDx technology from PCR methods.
SensDx S.A. is a company dealing with digital diagnostics. The company-introduced test provides rapid digital diagnostics for the presence of SARS-CoV-2 and influenza A / B virus in a throat swab. The test is performed using the SensDx Mobi diagnostic platform and disposable SARS-CoV-2 and influenza A / B microsensors. The test detects the presence of influenza A / B and SARS-CoV-2 virus-specific proteins by electrochemical impedance spectroscopy (EIS). The final test result is available within 5-6 minutes. The SensDx platform is portable, and the connection to the cloud enables the integration of processes with existing systems.
The first evaluation of SARS-CoV-2 test was performed internally on 100 positive and 500 negative samples (92% sensitivity and 98.5% specificity). An independent evaluation was carried out at the University of Life Sciences in Wrocław using 30 positive and 30 negative SARS-CoV-2 samples. 90% positive agreement (sensitivity) and 97% negative agreement (specificity) compared to the reference molecular polymerase chain reaction (PCR) method was demonstrated. The influenza A / B test was independently verified by a CRO at four different locations on 118 samples, resulting in a sensitivity of 93.7% and a specificity of 97.5%. Optimisation of the machine learning algorithm of the diagnostic platform will further improve the sensitivity compliance level over time.
The strategic partner and investor of SensDx is Neuca SA, which supports the rapid development of SensDx and owns 24.9% of its shares. NEUCA is a company operating on the healthcare market, combining its key areas.