AABB has engaged in an assessment of the risk that Babesia microti poses to the blood supply and the optimal approach to address the risk of transfusion-transmitted babesiosis. In anticipation of a draft FDA guidance on the topic, AABB convened the Ad Hoc Babesia Policy Working Group to carry out a risk-based decision making (RBDM) exercise to inform the Association's position.
The RBDM framework, developed by the Alliance of Blood Operators, was chosen because AABB believes it provides a thorough and structured process for making decisions about optimal strategies for risk mitigation in blood safety.
The Working Group's report summarized the literature on B. microti testing and supports the strategy of regional testing of blood donations for the parasite. AABB has previously supported a regional testing approach for B. microti, but, in doing so, acknowledged that clarification on the definition of high-risk regions is needed.
The Working Group’s
B. microti report is linked below. AABB encourages members to
review the report.
Also linked below are two B. microti-related papers published in the August 2018 issue of TRANSFUSION: an article summarizing the findings of the Working Group and relevant advances in research that have occurred since the report was completed; and a commentary that examines alternative perspectives on the conclusions of the Working Group's report.
AABB Babesiosis Risk-Based Decision-Making Assessment Report
Assessing the Risk of Babesia to the United States Blood Supply Using a Risk‐Based Decision‐Making Approach: Report of AABB's Ad Hoc Babesia Policy Working Group
Risk‐Based Decision Making: A Good Start to Aiding US Blood Policy Decisions?
Recommendations for Reducing the Risk of Transfusion-Transmitted Babesiosis; Draft Guidance for Industry
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March 21, 2023
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April 28, 2021