November 2020—Qiagen plans to launch a test that can detect SARS-CoV-2 antigens in people with active infections in less than 15 minutes and process, on average, 30 swab samples per hour using a small digital detection system. The test is expected to become available in the fourth quarter of this year.
The Access Anti-SARS-CoV-2 Antigen Test, developed in collaboration with Australian digital diagnostics company Ellume, uses the eHub, a portable machine that analyzes nasal-swab samples from up to eight symptomatic people at once, and an eStick, which uses nanoparticle fluorescent detection technology to flag the SARS-CoV-2 nucleocapsid protein. The device delivers negative results in 15 minutes and in the case of a strong positive, delivers results in three minutes.
Two versions of the antigen test are scheduled for launch in the United States in the fourth quarter—one for labs and one for point-of-care use. The company will apply for FDA emergency use authorization and seek CE-IVD registration in Europe.
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