Roche, Basel, Switzerland, has launched the Cobas Zika test for use on the company’s Cobas 6800/8800 molecular analyzers in markets accepting the CE mark. The Cobas Zika test detects Zika virus RNA in samples of human plasma and is intended for use in screening blood donations.
The Zika virus belongs to the Flaviviridae family of viruses, which also includes dengue, yellow fever, Japanese encephalitis, and West Nile viruses. Infection with the Zika virus is linked to brain defects in fetuses and newborn infants as well as to neurological complications in children and adults. The virus is spread mainly through the bite of infected mosquitoes. However, transmission through sexual intercourse and from pregnant mothers to fetuses has also been documented. Similar to other viruses in the Flaviviridae family, such as West Nile virus, it is suspected that infected donor blood used for transfusions could serve as an additional transmission route for the Zika virus.

“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,” says 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 minimize the risk of transmission through infected blood and plasma donations.”

Cobas 6800/8800

The Cobas 6800 (left) and 8800 (right) molecular analyzers from Roche.

In response to the Zika public health crisis of 2017, Roche worked closely with FDA to develop and launch the Cobas Zika test to ensure the safety of blood transfusions in the United States and its territories. Since then, the Cobas Zika test has been used to screen millions of blood donations from the United States and Puerto Rico, and has helped to identify and remove more than 350 potentially infectious donations from the blood supply.

According to the World Health Organization, more than 117 million blood donations are made worldwide every year. One blood donation has the potential to save as many as three lives, making a safe supply of blood and blood products extremely important for any patient who needs a transfusion.

The Cobas Zika test 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. The test is intended for use on Roche’s Cobas 6800 or Cobas 8800 molecular analyzers.

For more information, visit Roche.