Canada-based rapid vertical flow diagnostics provider MedMira has received the CE mark approval for its REVEALCovid-19 PLUS total antibody test.

REVEALCovid-19 PLUS is designed to detect the presence of total antibodies against SARS-CoV-2 generated by a previous infection or vaccination.

With the CE mark approval, the antibody test is now available in European Union (EU) member states and other countries that accept the CE mark.

The test is being offered as a single pack for individual use and in bulk packaging for standard screening.

MedMira CEO Hermes Chan said: “We believe the REVEALCovid-19 PLUS is our next step in Europe to support the health care system by allowing a more personalised responsibility approach by offering an easy testing tool and the quickest possible time.

“The use of our REVEALCOVID-19 PLUS will also give a great example of its quality and speed to our customers and open the path further for all our other products.

“During the various independent evaluations, we have received an overwhelming positive response on the quality and handling of our product, and we feel excited to launch this necessary and important product in Europe.”

According to the company, continuous screening for antibodies is crucial in determining a person’s antibody status, to assess the effectiveness of vaccination or post-infection.

The total antibody level of individuals who had recovered from Covid-19 or recently vaccinated, would reach the peak within a month, and will steadily fall, based on recent data.

MedMira said that its REVEALCovid-19 PLUS total antibody test requires less than three minutes to complete the testing, and delivers the results instantly.

Furthermore, the company is also planning to introduce its second antibody product in Europe, in few weeks, which will compliment the current total antibody test.

The new product, dubbed REVEALCovid-19 Nab-Y, is expected to provide a enhanced understanding of individual’s potential protection against SARS-CoV-2.