The assay is now approved to screen donated blood, plasma, organs and tissue for the three viruses in individual blood donations or in pools of up to 16 blood samples. The assay may be run on the enhanced semi-automated Procleix system and on the fully automated, high-throughput Procleix Tigris system, the company said.
Procleix and Ultrio are trademarks of Novartis Vaccines and Diagnostics and Tigris is a trademark of Gen-Probe.
Hank Nordhoff, Gen-Probe’s chairman and CEO, said: “Gaining full FDA approval of the Procleix Ultrio assay is an important milestone for our blood screening business. More importantly, demonstrating that the assay intercepts hepatitis B virus-infected blood donations that older tests miss is an important scientific finding that may help further safeguard the US blood supply. We are grateful to the blood screening centers that participated in the trials to demonstrate the utility of the assay.”