Zika Blood Screening Test to Markets Accepting the CE Mark Announced

Roche have announced the CE-IVD launch of the cobas® Zika test for use on the cobas®6800/8800 Systems. The cobas Zika test detects Zika virus RNA in samples of human plasma and is intended for use in screening blood donations. Building onto Roche's comprehensive menu of donor screening assays, this launch represents an important milestone in the effort to protect the blood supply from Zika virus globally. 

The Zika virus is mainly spread through the bite of infected mosquitoes. However, it is suspected that infected donor blood used for transfusions could serve as an additional transmission route for the Zika virus.

"Together with cobas® CHIKV/DENV to screen for chikungunya and dengue viruses, the cobas Zika test provides a solution for preserving blood safety in regions with local outbreaks of these tropical diseases or from donors who may have been exposed while traveling to outbreak areas," said Mario Torres, Head of Roche Molecular Diagnostics. "Launching the cobas Zika test in markets accepting the CE mark expands the emergency preparedness solution for our customers and helps minimise the risk of transmission through infected blood and plasma donations."

Manufactured by Roche, the cobas Zika test for use on the cobas 6800/8800 Systems is a qualitative in vitro nucleic acid screening test for the direct detection of Zika virus RNA in plasma specimens from donors of whole blood and blood components, and other living donors. Together with the cobas 6800/8800 Systems, the cobas Zika test provides solutions for blood services to detect the Zika virus and ensure that potentially infected blood units are not made available for transfusion. The fully automated cobas 6800/8800 Systems offer the fastest time to results with the highest throughput and the longest walk-away time available among automated molecular platforms, providing donor screening laboratories with improved operating efficiency and the flexibility to adapt to changing testing demands. The cobas Zika CE-IVD test is the latest addition to Roche's assay menu for donor screening laboratories - which includes cobas® MPX, cobas® DPX, cobas® HEV, cobas® WNV, cobas CHIKV/DENV and cobas® Babesia (FDA approved, not commercially available) - all of which run on the cobas 6800/8800 Systems. Not all assays are available in all markets.