Innova Medical Group has obtained CE Mark for its self-testing Innova SARS-CoV-2 Antigen Rapid Qualitative Test.
The new test is a lateral flow immunochromatographic assay that has been designed for the detection of SARS-CoV-2 extracted nucleocapsid protein antigens in nasal swab specimens collected directly from suspected Covid-19 individuals.
Innova SARS-CoV-2 Rapid Antigen Test provides results in 20 minutes and is claimed to be one of the world’s most studied lateral flow tests.
Findings from 1.7 million tests from independent studies, which were conducted in lab and field settings, showed that the test was able to detect infected individuals.
The test has been widely used in the UK since late 2020, under an emergency use authorization (EUA) granted by the Medicines and Healthcare products Regulatory Agency (MHRA).
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Including point-of-care and self-testing products, the SARS-CoV-2 antigen rapid test has been approved for distribution in 18 countries.
These countries include Austria, Bosnia, Denmark, Finland, France, Germany, Hong Kong, Ireland, Italy, Sweden, Oman, Thailand, Turkey, the Netherlands, Malaysia and the UK.
To help make at-home testing more accessible, the company intends to bring the test directly to consumers in the UK and the EU.
Innova Medical Group CEO Daniel Elliott said: “The CE Mark is yet another important milestone for our Rapid Antigen Test. We look forward to continuing our work with great partners as we expand our market presence further in our goal to bring our product to even more consumers and help make at-home testing accessible to all.”