Germany’s Qiagen to Launch Rapid COVID-19 Antigen Test

Qiagen, based in Hilden, Germany with offices in Germantown, Maryland, plans to launch a rapid portable tests for COVID-19 infections. The test is able to identify active infections in less than 15 minutes. It also is able to process about 30 swab samples per hour.

The Access Anti-SARS-CoV-2 Antigen Test is expected to launch in the fourth quarter of this year. This assay was developed for facilities that require a high volume of fast and accurate test results. There are actually two versions of the test, one for laboratories and the other for point-of-care (POC) use. The company plans to apply for Emergency Use Authorization (EUA) with the U.S. Food and Drug Administration (FDA) and in Europe for CE-IVD registration. If it gains a CLIA Waiver in the U.S.—CLIA is the part of Health and Human Services that oversees clinical diagnostic laboratories—the test should be utilized at sites such as airports or stadiums.

The feasibility and validation tests conducted on the test demonstrated a sensitivity of at least 90% and a specificity of 100%.

“The Access Anti-SARS-CoV-2 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,” said Thierry Bernard, chief executive officer of Qiagen. “It will deliver highly accurate results and will complement the gold-standard PCR tests used for detection of active COVID-19 infection. PCR tests offer a high level of diagnostic accuracy but are time-consuming and lab-bound.”

This announcement comes out the same time a report by the Rockefeller Foundation was published indicating the U.S. may need up to 193 million COVID-19 tests per month to safely reopen schools and ensure safety at nursing homes. Current testing capacity is approximately 21 million tests per month, per the Covid Tracking Project.

The test expands Qiagen’s partnership with Australia’s Ellume. It leverages Ellume’s digital eHub and eStick system. In August, Qiagen announced the Access Anti-SARS-COV-2 Antibody Test that utilizes the same devices.

The eHub that was launched in August is a portable instrument that can analyze nasal swab samples from up to eight symptomatic people at the same time. The eStick uses nanoparticle fluorescent detection technology to flag the SARS-CoV-2 nucleocapsid protein—that’s a molecule on the surface of the virus. The machine can give negative results in 15 minutes, and if there is a strong positive result, can provide it in as little as three minutes.

The same system for the Access Anti-SARS-CoV-2 Antigen Test and the Access Anti-SARS-CoV-2 Antibody test—the first tests for active infections, the latter for former infections—runs on the eHub platform that Qiagen uses for Access QuantiFERON-TB, for tuberculosis.

In addition to these efforts, Qiagen is “massively ramping up production capacity” for other test platforms for COVID-19. These include viral RNA extraction or use on the company’s QIAcube, QIAsymphony and EZ1 platforms in addition to third-party instruments, a range of PCR tests on the QIAstat-Dx and NeuMoDx systems for COVID-19 detection; and the Access Anti-SARS-COV2-Antibody test.

It also supplies next-generation sequencing solutions for research use with any sequencer, especially gene panels integrated with bioinformatics for analysis of the coronavirus that causes COVID-19, as well as sells reagents to other vendors for use in their own COVID-19 tests.

Qiagen hasn’t released a price for the test, although Bernard calls the tests “cost-effective.” The company also did not reveal details on how many tests it can manufacture, although they do indicate they are scaling up manufacturing capacity quickly.

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