The US Food and Drug Administration is contemplating a new requirement for blood banks to implement a test capable of detecting malaria-causing parasites in certain donors' blood. This initiative aims to prevent transfusion-related malaria cases while ensuring that eligible individuals can continue donating blood.
Malaria is a significant global health concern, with 249 million cases and over 608,000 deaths reported in 2022 by the World Health Organization. Although malaria is not a major threat to the US blood supply, the increasing number of Americans traveling to malaria-endemic regions raises concerns about potential transmission.
Historically, the US successfully eradicated malaria through strategic mosquito control efforts. However, sporadic cases still occur, primarily linked to travel. Recent instances of locally acquired malaria in states like Texas and Florida underscore the importance of vigilance.
The FDA recently approved the Cobas malaria test by Roche, designed to detect malaria parasites in donor blood. While transfusion-related malaria cases are rare, they can lead to severe complications, including fatalities.
The current donor screening process, based on travel history and residency in malaria-endemic regions, has limitations and may exclude healthy potential donors unnecessarily. The FDA is exploring updated guidelines, including selective testing based on malaria risk factors or testing all donors at least once.
Advisory committee members favor selective testing over universal screening, citing the low incidence of transfusion-related malaria and the treatability of the disease. The FDA is also considering mandatory testing in areas with recent local malaria transmission, although opinions on this proposal vary.
Blood supply organizations support the new malaria test but emphasize the need for clinical evidence on its effectiveness in reducing transfusion-transmitted malaria. They urge the FDA to adopt flexible testing strategies and conduct formal modeling studies before finalizing guidance.
While no decisions were made during the recent meeting, the FDA will consider the committee's feedback in shaping future guidelines to enhance blood safety and donor availability.
