COVID-19 antibody test that provides results in 13 minutes CE marked

Danish company BluSense Diagnostics has received the CE mark for COVID-19 antibody test, which provides laboratory-grade accuracy in 13 minutes.

ViroTrack COVID-19 serology test detects three COVID-19 antibodies (IgA, IgM and IgG) and helps determine a patient's immune response as well as monitor all antibodies generated through disease progression. It was evaluated in collaboration with Hvidovre hospital.

BluSense Diagnostics CEO and founder Filipp Bosco, said: “It is a great achievement, as we developed and CE-marked the diagnostics product in as little as three months. This would not have been possible without the hard work of our team and our patented technology – Immuno-Magnetic Assay (IMA), which can be scaled to almost any infectious disease.

“We are proud to provide an antibody test as it will identify who has had the virus and possibly is immune to it. The knowledge could also play a critical role in supporting the development of vaccines and surveillance efforts.”

During the clinical evaluation study in Hvidovre hospital, more than 100 samples were tested with ViroTrack COVID-19 antibody test comparing the performance to the laboratory tests that are leading in the market. The results showed that the test developed by BluSense Diagnostics demonstrates above 90% accuracy in eight days or more after the symptoms started as well as a very high performance during the early stage of the infection.

Bosco added: “Our product employs the best of two worlds - it has the convenience of the rapid diagnostics and the high accuracy of the laboratory tests. Because of that, we can deploy it in decentralized clinical settings, where time and great reliability are of paramount importance.”

When hospitals examine patients for COVID-19, the sample is sent to the hospital's laboratory for analysis, which can takes hours or even a few days. The ViroTrack COVID-19 serology test, which runs on a fully automated and portable analyser BluBox, allows to shorten the testing time and provides automated on-the-spot sample processing.