QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced plans to launch a rapid portable test that can detect SARS-CoV-2 antigens in people with active infections in less than 15 minutes and process on average around 30 swab samples per hour using a small digital detection system.
The Access Anti-SARS-CoV-2 Antigen Test, which is expected to become available in the fourth quarter of 2020, is designed for environments that require a high volume of fast and accurate test results. The portable test offers a new combination of speed and scale that marks an important step towards decentralized mass testing that health authorities all over the world have been urgently seeking.
The Access Anti-SARS-CoV-2 Antigen Test extends the partnership with Ellume, an Australian digital diagnostics company. It is the second QIAGEN COVID-19 test to make use of Ellume’s digital eHub and eStick system. QIAGEN in August announced the Access Anti-SARS-CoV-2 Antibody Test that uses the same devices.
Two versions of the Antigen Test are scheduled for US launch in the fourth quarter – one for labs and one for point-of-care (POC) use. QIAGEN will apply for FDA Emergency Use Authorization and seek CE-IVD registration in Europe. A CLIA Waiver in the US would allow the POC version to be used in settings like airports or stadiums.
Feasibility tests have shown the Access Antigen Test to have a sensitivity of at least 90% and a specificity of 100%.
Please find the full press release here.
Further information on QIAGEN’s response to the coronavirus outbreak can be found here.
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