Research & Development
QIAGEN wins US FDA's EUA for QIAreach Anti-SARS-CoV-2 Total Test
13 May 2021 -

Sample and assay technologies provider QIAGEN N.V. (NYSE:QGEN) (Frankfurt Prime Standard:QIA) said on Wednesday that it has received the US Food and Drug Administration's (FDA) Emergency Use Authorization (EUA) for its QIAreach Anti-SARS-CoV-2 Total Test.

This FDA clearance means that QIAGEN can start making its portable antibody testing device available to healthcare professionals in the United States.

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%. QIAGEN's technology detects total antibodies (total immunoglobulin) specific to SARS-CoV-2 immune response, whereas most other tests currently identify only selected antibodies.

Each antibody test takes about 10 minutes to identify whether a person carries antibodies to the SARS-CoV-2 virus as a result of prior infection. Individual test results are read on a digital eHub device that can process up to 32 tests per hour and will eventually also run the antigen test.



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