The U.S. Food and Drug Administration (FDA) has published, “Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria Draft Guidance for Industry.” The recommendations are applicable to the collection of whole blood and blood components, except source plasma. The Malaria Draft Guidance focuses on blood donation and shifts away from current deferral-based strategies to a selective testing approach.
Under the agency’s recommendations, blood establishments may implement one of the following procedures:
- “[a] selective testing strategy to:
- test donations, using an FDA licensed donor screening NAT, from donors who have ever had malaria or resided in or traveled to a malaria-endemic country; and
- test donations collected in regions of the U.S. that FDA identifies as having local, mosquito-borne malaria transmission; or
- implementation of pathogen reduction technology for platelets and plasma donations using an FDA-approved pathogen reduction device indicated for use against P. falciparum, when collected from donors who have had malaria or resided in or traveled to a malaria-endemic country or collected in regions of the U.S. that FDA identifies as having local, mosquito-borne malaria transmission.”
The malaria Draft Guidance also recommends:
- “[u]pdate donor history questionnaire and conduct a medical history interview at each donation;
- [d]efer a donor who is not in good health or who has clinical evidence of a relevant transfusion-transmitted infection, including malaria. Defer the donor for at least one year or until the donor is free of malaria if the donor reports symptoms of or is being treated for malaria;
- [t]est each donation from donors who report a history of malaria;
- [t]est at least one time a donor who reports they are a prior resident of a malaria-endemic country;
- [t]est each donation from a donor who reports travel to a malaria-endemic country in the past 12 months;
- [u]pon notification by FDA via a posting on the agency’s website, test each donation collected in a region of the U.S. with local, mosquito-borne malaria transmission ;
- a]lternatively, for platelets and plasma donations, implement pathogen reduction technology using an FDA-approved pathogen reduction device when collected from donors who have had malaria or resided in or traveled to a malaria-endemic country or collected in regions of the U.S. that FDA identifies as having local, mosquito-borne malaria transmission. [d]efer donors with a reactive NAT result for Malaria for at least one year.”
America’s Blood Centers (ABC) previously submitted malaria testing recommendations in comments to the FDA Blood Products Advisory Committee (BPAC) in May 2024 that, “strongly recommended” that the agency delay publishing draft guidance until modeling studies are finished and additional malaria testing assays are approved and available.” ABC will submit comments regarding the malaria draft guidance for blood centers to FDA by the March 17th deadline. Member blood centers are encouraged to share input by February 3rd.