Emerging Tests

Qiagen Launches Portable COVID-19 Antigen Digital Testing Hub

The rapid evolution of COVID-19 testing in response to the need for speed and mobility continues. One notable development on the antigen testing front is Qiagen’s U.S. rollout of a portable digital test called QIAreachSARS-CoV-2 Antigen Test that laboratories can use to detect SARS-CoV-2 antigens in people with active infections in two to15 minutes. The company announced its intention to launch the test back in September.

The Qiagen Test

Qiagen, which had been targeted for acquisition by Thermo Fisher Scientific before the pandemic and massive spike in demand for Qiagen’s COVID-19 testing products intervened, developed the new antigen in partnership with Australian digital-diagnostics company, Ellume based on the hub-and-stick system the companies originally developed for use in rapid tuberculosis diagnostics. The QIAreach Antigen test contains a rechargeable battery for eight hours of remote use and can connect to laboratory software to record results.

The digital device automates and standardizes analysis of the results, without requiring laboratory staff to manually inspect and record the outcome of each sample. Previous tests of clinical samples have shown a false-negative rate of 10 percent, while delivering zero false positives. The hub can also process antigen and antibody tests side-by-side.

According to Qiagen, the QIAreach Antigen test’s capacity to provide digital results for more than 30 swab samples per hour while processing antibody tests in parallel, establishes a new standard for scalability and flexibility. The company believes this to be an important step toward decentralized mass screening by processing samples in a short period.

Takeaway

Qiagen has begun to market and distribute this latest test in the U.S. after filing for Food and Drug Administration emergency use authorization (EUA) for symptomatic patients. CE-IVD registration for the European Union and other markets is expected by the end of the year. The company plans to have the authorization amended before the end of this year to enable its use at the point of care, and it is also pursuing an in vitro diagnostic CE marking in Europe.

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