Qiagen Gets Emergency Use Authorization for COVID-19 Test
The FDA has granted Qiagen Emergency Use Authorization for its QIAreach SARS-CoV-2 antigen test, a rapid, portable COVID-19 test developed in collaboration with the Australian company Ellume.
The newly authorized antigen test and the previously authorized QIAreach SARS-CoV-2 antibody test run on the company’s eHub platform, a portable reader with backup battery power.
Qiagen says its clinical studies have shown the antigen test has a sensitivity of at least 80 percent and a specificity of 98 percent.
The company’s QIAreach SARS-CoV-2 antigen test can provide results in two to 15 minutes by analyzing more than 30 samples per hour for the antigen of the virus that causes COVID-19.