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Recognizing the increasing threat of transfusion-transmitted babesiosis to the US blood supply, the AABB Board of Directors tasked an Ad Hoc Babesia Policy Working Group (the Working Group) to use the Alliance of Blood Operators' risk-based decision-making (RBDM) framework to assess the risks and benefits of introducing Babesia donation testing in the United States. The regional nature of the Babesia microti risk added complexity to the RBDM assessment because of the unique operational and financial considerations for operators and hospitals located in endemic states. Therefore, the assessment considered safety, product availability, sector sustainability, and technology availability. After assessing safety risk, economic and operational impact, reimbursement equity, ethical considerations, and stakeholder feedback from two consultations, the Working Group concluded that a regional approach to donor screening in endemic states was appropriate because it applied the intervention where the risk was highest and appropriately allocated cost to the risk. Nucleic acid testing using a ribosomal RNA template was the recommended intervention because it was the most cost-effective, resulted in no wasted units, and captured similar numbers of infections as antibody plus DNA-based polymerase chain reaction. The current model for blood reimbursement was maintained but AABB was encouraged to facilitate collection of data to identify threats to sector sustainability in endemic states. Babesia expansion was acknowledged with a mechanism to regularly reevaluate what are "endemic states." Finally, given that public awareness of the Babesia threat is the first line of defense, AABB should work with appropriate agencies for general education about the health risk from B. microti.
Recognizing the increasing threat of transfusion-transmitted babesiosis to the US blood supply, the AABB Board of Directors tasked an Ad Hoc Babesia Policy Working Group (the Working Group) to use the Alliance of Blood Operators' risk-based decision-making (RBDM) framework to assess the risks and benefits of introducing Babesia donation testing in the United States. The regional nature of the Babesia microti risk added complexity to the RBDM assessment because of the unique operational and financial considerations for operators and hospitals located in endemic states. Therefore, the assessment considered safety, product availability, sector sustainability, and technology availability. After assessing safety risk, economic and operational impact, reimbursement equity, ethical considerations, and stakeholder feedback from two consultations, the Working Group concluded that a regional approach to donor screening in endemic states was appropriate because it applied the intervention where the risk was highest and appropriately allocated cost to the risk. Nucleic acid testing using a ribosomal RNA template was the recommended intervention because it was the most cost-effective, resulted in no wasted units, and captured similar numbers of infections as antibody plus DNA-based polymerase chain reaction. The current model for blood reimbursement was maintained but AABB was encouraged to facilitate collection of data to identify threats to sector sustainability in endemic states. Babesia expansion was acknowledged with a mechanism to regularly reevaluate what are "endemic states." Finally, given that public awareness of the Babesia threat is the first line of defense, AABB should work with appropriate agencies for general education about the health risk from B. microti.
BACKGROUNDThe AABB Clinical Transfusion Medicine Committee (CTMC) compiles an annual synopsis of the published literature covering important developments in the field of transfusion medicine (TM) for the board of director's review. This synopsis is now made available as a manuscript published in TRANSFUSION.STUDY DESIGN AND METHODSCTMC committee members review original manuscripts including TM‐related topics published in different journals between late 2018 and 2019. The selection of topics and manuscripts are discussed at committee meetings and are chosen based on relevance and originality. After the topics and manuscripts are selected, committee members work in pairs to create a synopsis of the topics, which is then reviewed by two committee members. The first and senior authors of this manuscript assembled the final manuscript. Although this synopsis is comprehensive, it is not exhaustive, and some papers may have been excluded or missed.RESULTSThe following topics are included: infectious risks to the blood supply, iron donor studies, pre‐transfusion testing interference and genotyping, cold agglutinin disease (CAD), HLA alloimmunization in platelet transfusions, patient blood management, updates to TACO and TRALI definitions, pediatric TM, and advances in apheresis medicine.CONCLUSIONThis synopsis provides easy access to relevant topics and may be useful as an educational tool.
Background: Human babesiosis is a zoonotic infection caused by an intraerythrocytic parasite. The highest incidence of babesiosis is in the United States, although cases have been reported in other parts of the world. Due to concerns of transfusion-transmitted babesiosis, the US Food and Drug Administration (FDA) recommended year-round regional testing for Babesia by nucleic acid testing or use of an FDA-approved device for pathogen reduction. A new molecular test, cobas Babesia (Roche Molecular Systems, Inc.), was evaluated for the detection of the four species that cause human disease, Babesia microti, Babesia duncani, Babesia divergens, and Babesia venatorum. Study design and methods: Analytical performance was evaluated followed by clinical studies on whole blood samples from US blood donations collected in a special tube containing a chaotropic reagent that lyses the red cells and preserves nucleic acid. Sensitivity and specificity of the test in individual samples (individual donation testing [IDT]) and in pools of six donations were determined.Results: Based on analytical studies, the claimed limit of detection of cobas Babesia for B. microti is 6.1 infected red blood cells (iRBC)/mL (95% confidence interval [CI]:
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