QIAGEN has started commercialization of a portable digital test in the United States that can be used by laboratories to detect SARS-CoV-2 antigens in people with active infections in 2-15 minutes. A point of care (POC) claim will be added and EUA amended later this year.
The QIAreach™ SARS-CoV-2 Antigen Test, developed in partnership with the Australian digital diagnostics company Ellume, sets new standards in scalability, validation and flexibility by processing more than 30 swab samples per hour, providing digital test results that do not require subjective interpretation, and allowing antibody tests to run simultaneously with antigen tests. This flexibility will be particularly valuable when vaccines are introduced.
QIAGEN has begun marketing and distributing QIAreach™ SARS-CoV-2 Antigen Test in the United States after applying for FDA emergency use authorization (EUA) for symptomatic patients. CE-IVD registration for European Union and other markets is expected as early as by the end of the year.
“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,” said Thierry Bernard, Chief Executive Officer of QIAGEN. “QIAreach SARS-CoV Antigen is a fast, digital and easy to use test that makes use of sensitive nanoparticle technology from Ellume. In as little as two minutes it allows objective reading of test results that provide clear qualitative interpretation. And it addresses the growing need for higher throughput testing for SARS-CoV-2 antigen by processing up to eight tests per hub simultaneously.”
Testing of clinical samples have shown the QIAreach™ SARS-CoV-2 Antigen Test to have a sensitivity of 90% and a specificity of 100%. It is the second QIAGEN COVID-19 test to make use of the digital eHub and eStick system made by its partner Ellume. QIAGEN in August announced the QIAreach™ Anti-SARS-CoV-2 Antibody Test – and both tests can run on the digital platform interchangeably.
The portable system provides a true walkaway solution with random access and does not require maintenance or calibration. It contains a rechargeable battery for eight hours of remote use and can fully connect to laboratory information management systems (LIMS) with an optional use software. The eHub will also run the QIAreach QuantiFERON®-TB test, a novel test for the detection of latent tuberculosis infections in low resource and high burden settings that is currently in development.
QIAreach™ SARS-CoV-2 Antigen Test uses the rugged and portable eHub to analyze eight eSticks with nasopharangeal-swab samples from symptomatic people at once, each test running independently of the others. The easy-to-use eStick uses nanoparticle fluorescent detection technology to flag the SARS-CoV-2 nucleocapsid protein, an antigen present on the inside of the virus. The device can detect strong positive cases in as little as two minutes and negative cases in 15 minutes.
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