May 2026—The FDA has approved Grifols’ Procleix Plasmodium assay for screening blood donors for malaria. The nucleic acid test uses magnetic-based target capture, transcription-mediated amplification, and chemiluminescence to detect the presence of specific ribosomal RNA sequences of five species of Plasmodium parasites that cause malaria in humans (P. falciparum, P. knowlesi, P. malariae, P. ovale, and P. vivax) in whole blood specimens from blood donors. It is for use on the Procleix Panther system.
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