Grifols said the FDA approved its automated Procleix Plasmodium assay used with the Procleix Panther system to screen blood donors for malaria risk. The nucleic-acid-based test is intended to detect ribosomal RNA sequences from five Plasmodium species. The company said the assay uses whole-blood samples with magnetic target capture, transcription-mediated amplification, and chemiluminescence detection to identify Plasmodium falciparum, P. knowlesi, P. malariae, P. ovale, and P. vivax. Grifols noted that, in the past, blood banks primarily relied on donor questionnaires about travel or residence in endemic areas. Approval of an automated assay adds a new layer of blood-safety screening capacity as transfusion-related risk management continues to evolve internationally.
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