The U.S. Food and Drug Administration (FDA) Blood Products Advisory Committee (BPAC) has released the BPAC Malaria meeting materials for the committee’s May 9th meeting. Included in the BPAC malaria meeting materials are a briefing document and meeting discussion questions.
The BPAC meeting materials describe the proposed strategies under consideration by the BPAC as:
- “selective testing strategy for individuals with a history of malaria;
- selective testing strategy for prior residents of malaria-endemic countries;
- selective testing strategy for residents of nonendemic countries who travel to malaria endemic areas in the past three months; [and]
- testing strategy for donations in regions of the U.S. with local, mosquito-borne malaria transmission.”
In the BPAC malaria meeting materials, the committee is specifically being asked to comment on:
- “FDA’s proposed strategies for selectively testing blood donations from donors at risk for malaria using an FDA-licensed nucleic acid test (NAT); [and]
- FDA’s proposal that blood establishments should implement time limited NAT screening of all donations collected in area(s) of the U.S. when a single case of local mosquito-borne malaria is reported by public health authorities.”
The FDA explained in the BPAC malaria meeting materials briefing document that, “we support these selective NAT testing strategies to identify individuals who are carrying Plasmodium parasite nucleic acid and to reduce the number of unnecessary deferrals of healthy individuals based on screening questions, alone. We considered and rejected more complicated selective testing strategies because of the operational complexity and higher likelihood of error. We also considered and rejected universal testing of all donations in lieu of such selective testing strategies, because the disadvantages outweighed the advantages and would be unlikely to materially increase safety compared to a selective strategy. Universal testing of all donations would permit dis-continuation of the malaria risk questions entirely and would address all three failure modes of current Donor History Questionnaire (DHQ) screening and deferral (staff error, nondisclosure of risk factors by the donor, and insufficient deferral periods to identify persistent, asymptomatic infection). While a universal testing strategy would simplify donor screening and donation testing algorithms and streamline operations, it would be at the expense of a greater testing burden and a larger number of donor deferrals associated with false positive test results.”
The BPAC malaria meeting materials added that the FDA is proposing a deferral period, “for at least one year after a reactive NAT result for Plasmodia spp. and until completion of medical evaluation and all prescribed treatment. The reactive donation would be unsuitable and must not be released for transfusion or further manufacturing (21 CFR 630.30). Blood establishments would be required to perform further testing using an FDA cleared diagnostic test to provide additional information concerning the donor’s infection status (21 CFR 610.40 (e)). At this time, we do not have sufficient information to propose a testing algorithm for reentering a donor before the one-year deferral period if false-positive screening test results are suspected. Therefore, all donors with reactive NAT results would become eligible again only after the one-year deferral and medical evaluation. The donation may or may not be tested again based on selective testing strategy.”