VENLO (dpa-AFX) - 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%.
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