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EQL Pharma AB will soon begin deliveries of Europe's first EC-certified and CE-marked SARS-CoV-2 self-test intended for detection of Covid-19 infection. In Sweden, there are previously two non-CE marked antigen-based self-tests that have been granted a temporary exemption by the Medical Products Agency. The self-test will be available in selected pharmacy chains during the second half of May.
"We are happy and proud to be able to launch this self-test with our partners to Swedish consumers, households and workplaces. Our self-tests are of a high quality with a sensitivity, ie sensitivity to detect viruses, of 96.2% and a specificity, ie correct identification of the virus, of 99.2%. The test answer is normally obtained after a few minutes up to a maximum of 15-20 minutes, "says EQL Pharma's CEO, Christer Fåhraeus.
An advantage of a self-test is that it can be used for screening in, for example, workplaces and other institutions, where there are many physically present people, without the requirement for the presence of health care personnel or a load of laboratory resources. If the self-test shows SARS-CoV-2 infection, it is recommended to then do a so-called PCR test, performed by healthcare professionals, to ensure infection. The Swedish Public Health Agency has recently (April 19) provided guidance on antigen tests and self-tests for Covid-19, which can be read on their website.