QIAGEN has developed the new SARS-CoV-2 antibody test in collaboration with the Australian digital diagnostics company Ellume
QIAGEN has unveiled plans to launch its new Access Anti-SARS-CoV-2 Total test, an easy-to-use digital test designed to detect antibodies in individuals exposed to the SARS-CoV-2 virus, in the US.
The Germany-based molecular diagnostics firm has developed the antibody test in collaboration with the Australian digital diagnostics company Ellume.
The planned US launch of the digital test follows the company’s filing with the US Food and Drug Administration (FDA) for the Emergency Use Authorization (EUA), with plans to obtain a CE-IVD marking for Europe and other markets, in the coming weeks.
The company plans to begin first shipments of the tests in late August 2020.
QIAGEN chief medical officer Davide Manissero said: “Increased testing is the only way to gain visibility on the magnitude of the pandemic, which will ultimately lead to helping control it.
“As a trusted partner in the fight against Covid-19, QIAGEN has now added the Access Anti-SARS-CoV-2 to our portfolio as a smart solution for antibody testing that provides results with confidence.
“This is a rugged and portable platform that requires no hardware, can process a wide range of tests and provides fast results. We look forward to working with Ellume to discover and develop additional tests for this platform.”
Access Anti-SARS-CoV-2 Total is a rapid digital test that runs on portable eHub device
The new Access Anti-SARS-CoV-2 Total is an easy-to-use rapid digital test designed to run on eHub, a portable device that provides results in around 10 minutes. The test has demonstrated 100% sensitivity and 100% specificity.
The eHub devices leverage nanoparticle fluorescent detection technology to test serum or plasma from patient samples. Each device is capable of simultaneously handling up to eight patient samples and performing up to 32 total tests per hour.
The same nanoparticle fluorescent detection technology is being used in QuantiFERON-TB Access, the company’s new solution for the diagnosis of latent tuberculosis (TB) infection.