Cobas Zika Test Gains Expanded FDA Approval
The Food and Drug Administration (FDA) approval of an additional claim for the cobas® Zika test for use on the cobas® 6800/8800 Systems.
The newly approved claim allows for the streamlined screening of multiple individual blood or plasma donations, which have been pooled together.
This new claim approval follows the recommendations made at the December 2017 meeting of the Blood Products Advisory Committee (BPAC), advisors to the FDA.
In addition to supporting the most recent BPAC recommendations, the extended claims for cobas® Zika facilitate a simplified testing workflow for blood screening laboratories in the United States.
Similar to other Flaviviridae family viruses, such as West Nile Virus, it is suspected that infected donor blood used for transfusions could serve as an additional transmission route for Zika virus.
"More than 6 million blood donations from the United States and Puerto Rico have been screened with the cobas® Zika test since 2016 and subsequent commercial approval in 2017," said Uwe Oberlaender, Head of Roche Molecular Diagnostics.
The cobas® Zika initial testing protocol enabled the reinstatement of the blood services in Puerto Rico after concerns over the high rates of infection locally posed a significant threat to the blood supply.
Manufactured by Roche, the cobas Zika test for use with the cobas® 6800/8800 Systems and cobas® Synergy software, is a qualitative in vitro nucleic acid screening test for the direct detection of Zika virus RNA in plasma specimens from individual human blood donors.
Automated data management is performed by the cobas®6800/8800 software, which assigns a test result for each test as non-reactive, reactive, or invalid.
Together with the cobas® 6800/8800 Systems, the cobas® Zika test provides solutions for blood services to detect Zika virus and ensure that potentially infected blood units are not made available for transfusion.
The Zika virus belongs to the Flaviviridae family of viruses, which includes dengue, yellow fever, Japanese encephalitis and West Nile viruses.
A growing body of evidence confirms the links between Zika virus infection and defects in fetuses and newborns, as well as neurological complications in children and adults.
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