Qiagen is preparing to launch its portable coronavirus antigen test, using a digital hub and up to eight interchangeable test-stick cartridges to process more than 30 samples per hour.
Individual results are expected to take between two and 15 minutes, depending on the amount of antigens in each swab sample. Qiagen and its development partner, the Australia-based Ellume, hope the diagnostic will help provide decentralized mass screening for COVID-19.
Qiagen has begun marketing and distribution efforts in the U.S., where the test is currently under review for an emergency laboratory use by the FDA. 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 mark in Europe.
“As existing approaches often lack scalability and accuracy, antigen testing is playing an increasingly important role in national testing strategies as a complementary tool to PCR, the gold-standard for detecting active COVID-19 infections,” Qiagen CEO Thierry Bernard said in a statement.
The QIAreach antigen test is built on the same hub-and-stick system developed by Qiagen and Ellume for COVID-19 antibody testing, after it had previously been used for rapid tuberculosis diagnostics.
The rugged digital device aims to automate and standardize analysis of the results, without requiring lab staff to manually inspect and record the outcome of each sample. Previous tests of clinical samples have shown a false-negative rate of 10%, while delivering zero false positives.
“In as little as two minutes it allows objective reading of test results that provide clear qualitative interpretation,” Bernard said. “And it addresses the growing need for higher throughput testing for SARS-CoV-2 antigen by processing up to eight tests per hub simultaneously.”
The hub can also process antigen and antibody tests side-by-side, which the companies say will come in handy once vaccines are made available to the public. It contains a rechargeable battery for eight hours of remote use and can connect to laboratory software to record results.