Shortly after unveiling a portable, digital testing system for COVID-19 antibodies late last month, Qiagen has now announced plans to leverage the same platform for a rapid antigen test to identify active coronavirus infections.
Developed in collaboration with Australian test maker Ellume, the system’s digital hub is able to process up to eight test sticks at the same time, or more than 30 swab samples per hour. It aims to provide independent results in under 15 minutes.
Additionally, each hub can simultaneously run antigen and antibody tests side-by-side, and one user can operate multiple hubs, the company said.
Qiagen said it expects to make its Access antigen test available in the fourth quarter of this year, with two versions—one for use in testing laboratories, and another for point-of-care and other various locations, such as airports and schools.
“The Access Antigen Test is fast, easy to use and cost-effective and will be a valuable tool to address the so far unmet high-volume testing needs for SARS-CoV-2 antigens in situations where time is of the essence,” Qiagen CEO Thierry Bernard said.
According to the company, the test has a false-negative rate of under 10% and a false-positive rate of zero, with results in as fast as three minutes in strong cases. Qiagen plans to apply for FDA authorization and a CE mark, as well as a CLIA waiver for point-of-care use.
Previously, Qiagen preordered 900,000 antibody tests and systems from Ellume for sale in the U.S. and is currently awaiting an FDA authorization for their use.