Malaria, caused by five Plasmodium species (e.g., P. falciparum), is recognized as a significant transfusion-transmitted infection by the U.S. Food & Drug Administration (FDA). Although malaria was eradicated in the U.S. in the 1950s, approximately 2,000 cases were imported by travelers in 2000. Locally acquired mosquito-borne cases, though sporadic, are becoming an increasing public health concern. The current FDA guidance, issued in 2022, aims to reduce transfusion-transmitted malaria by recommending a deferral period of either three months or three years, depending on donor’s risk factors—such as travel to malaria-endemic areas, prior residency in such regions, and history of malaria. However, this guidance results in the deferral of about 1% of donors (~150,000 individuals each year), many from Africa and South-East Asia, thereby limiting the genetic diversity of the blood supply. Thus, the FDA has issued new draft guidance to reduce transfusion-transmitted malaria for all blood donations and components, except Source Plasma. The updated guidance calls for selective testing of at-risk donors using an FDA-approved nucleic acid test—specifically the cobas Malaria test (Roche Molecular Systems), which received FDA approval in March 2024. Additionally, FDA-approved pathogen reduction devices may be used for platelets and plasma. Every donation from a donor who ever tested positive for malaria or a history of malaria should be tested. Donations from donors who have lived in a malaria endemic country for more than 5 years should be tested at least once. Donations from donors who have travel to a malaria endemic country in the past 12 months should also be tested. Finally, testing is required for all donations collected in U.S. regions experiencing on-going local malaria transmission. Blood establishments are encouraged to provide feedback on this draft guidance and to update their donor history questionnaires to reflect these forthcoming changes.
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