QIAGEN to launch digital test for rapid detection of SARS-CoV-2 antibodies following FDA EUA
QIAGEN has announced the U.S. launch of the new Access Anti-SARS-CoV-2 Total test, according to a press release from the company. The digital test is performed on a portable device that provides results in about 10 minutes to detect antibodies in people exposed to the SARS-CoV-2 virus.
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 the 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 percent (CI 88.43–100.00 percent) and specificity of 100 percent (CI 95.20–100.00 percent).
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.
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.
