Germantown, Maryland, and Hilden, Germany – QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the U.S. launch of the new Access Anti-SARS-CoV-2 Total test, an easy-to-use digital test done on a portable device that provides results in about 10 minutes to detect antibodies in people exposed to the SARS-CoV-2 virus, which is the case of COVID-19.

The launch of this antibody test, which was developed in partnership with the Australian digital diagnostics company Ellume, comes after the submission by QIAGEN of this unique antibody test to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA). First shipments are planned for late August 2020. A CE-IVD marking for Europe and other markets is planned in the coming weeks.  

The new serological test has been shown to have sensitivity of 100% (CI 88.43–100.00%) and specificity of 100% (CI 95.20–100.00%).

“Increased testing is the only way to gain visibility on the magnitude of the pandemic, which will ultimately lead to helping control it,” said Dr. Davide Manissero, M.D., Chief Medical Officer of QIAGEN. “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.”

The test is performed on the eHub, a small portable digital device that provides reliable results in 10 minutes. Each eHub can handle up to eight patient samples simultaneously and can perform up to 32 total tests per hour. The nanoparticle fluorescent detection technology uses serum or plasma from patient samples. The same platform is being used for QuantiFERON-TB Access, a new solution in development for diagnosis of latent tuberculosis (TB) infection in low-resource regions with a high TB disease burden.

Currently available rapid lateral flow antibody tests fall short when it comes to the automated and convenient read-out of results. Manual and visual result reporting, and potential pitfalls in read-out timing can lead of uncertain testing results. The Access Anti-SARS-CoV-2 eHub and digital eStick approach mitigates those risks, providing reliable results no matter when the results are read and also providing true walk-away capability to free up laboratory personnel.

Serological testing for antibodies is central to identifying people who have been recently infected by the virus or have been infected in the recent past, especially those who did not show any symptoms and therefore might not know of an infection. Understanding more about COVID-19 immunity in a population could help societies return faster to normal daily routines by helping to inform and guide public health measures, such as contact tracing and individual measures under clinical guidance. Antibody testing could also become fundamental in supporting vaccine development as well as guiding, planning, and assessing future SARS-CoV-2 immunization programs.

Access Anti-SARS-CoV-2 will complement QIAGEN’s array of COVID-19 testing solutions with a cost-effective way to detect immune responses in people who have been exposed to the virus.  

QIAGEN employees around the world are fully mobilized to address the urgent demand for testing solutions needed in the global response to the coronavirus pandemic. QIAGEN’s initiatives focus on building the most comprehensive portfolio of solutions for COVID-19 testing. These include production of viral RNA extraction for use on QIAGEN’s QIAcube, QIAsymphony and EZ1 platforms as well as third-party instruments; building up a range of PCR tests on the QIAstat-Dx and NeuMoDx systems that enable COVID-19 detection while analyzing samples at the same time for other respiratory infections; QIAGEN is also providing universal next-generation sequencing (NGS) solutions for research use with any sequencer, in particular gene panels integrated with bioinformatics for analysis of the SARS-CoV-2 virus. QIAGEN is also scaling up production capacity for reagents sold to other companies for use in their own COVID-19 tests.

Further information on QIAGEN’s response to the coronavirus outbreak can be found here.