Photo by Marja Helander
Blood donor
The US Food and Drug Administration (FDA) has approved the Procleix® Zika Virus Assay for blood screening.
The assay is approved to detect Zika virus in individual or pooled plasma specimens from human donors, including volunteer donors of whole blood and blood components for transfusion.
The assay is also approved for testing plasma or serum specimens to screen other living or cadaveric organ donors and human cells, tissues, and cellular and tissue-based products.
The Procleix Zika Virus Assay, which was developed by Hologic, Inc. and Grifols, is designed to run on the Procleix Panther System. The Procleix Panther System automates all aspects of nucleic acid technology-based blood screening on a single, integrated platform.
The Procleix Zika Virus Assay has been in use in the US since June 2016, when it was authorized under an investigational new drug protocol to screen donated blood collected in the US.
Also in 2016, the assay was CE-marked for use in European countries conforming to CE Mark regulations.