QIAGEN's Covid-19 Antibody Test Gets Emergency Use Authorization From FDA

(RTTNews) - Qiagen N.V. (QGEN) Wednesday said that FDA has given Emergency Use Authorization to its Covid-19 test QIAreach Anti-SARS-CoV-2 Total Test.

The approval allows Qiagen to start making its portable antibody testing device available to health-care professionals in the U.S. According to the company, the antibody test takes only about 10 minutes to identify whether a person carries antibodies to the SARS-CoV-2 virus as a result of prior infection.

The QIAreach Anti-SARS-CoV-2 Total Test is a serological test that has been shown to have a sensitivity of 93.85% and a specificity of 97.83%.