Photo by Daniel Gay
Blood in bags and vials
The US Food and Drug Administration (FDA) has approved 2 Grifols blood screening assays—Procleix Ultrio Elite and Procleix WNV.
Procleix WNV is a qualitative in vitro nucleic acid assay for the detection of West Nile virus RNA in plasma and serum of human blood donors.
Procleix Ultrio Elite is a blood screening assay that delivers simultaneous results for human immunodeficiency virus type 1, hepatitis C virus, and hepatitis B virus. It also detects human immunodeficiency virus type 2.
Procleix Ultrio Elite can be used to test pools of plasma composed of up to 96 individual donations from donors of source plasma.
Grifols will begin commercializing the Procleix Ultrio Elite and Procleix WNV assays in the US later this year.
“These FDA approvals demonstrate our ongoing commitment to expand Grifols comprehensive nucleic acid testing (NAT) solutions portfolio to help labs administer NAT,” said Carsten Schroeder, president of Grifols’s Diagnostic Division.
Procleix Ultrio Elite and Procleix WNV will run on the fully automated NAT blood screening platform Procleix Panther system. The device is an integrated NAT system that fully automates all necessary steps to perform Procleix assays, from sample processing through amplification, detection, and data reduction.
“The addition of the Procleix Panther system with these assays will allow blood centers to efficiently screen for infectious diseases on one simple, automated platform while adapting to changes in donation volume and regulatory requirements,” Schroeder said.