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Development of a Blood Donor Screening Test to Prevent Transfusion Transmitted Babesiosis



Babesiosis is a potentially life-threatening zoonotic disease caused by intraerythrocytic protozoan parasites, which usually are tick-borne but are also transmissible by transfusion. Most infections are asymptomatic or only causemild disease but severe disease can occur in neonates, the elderly and immunocompromised patients. Babesiosis became nationally notifiable in January, 2011.

Blood transfusion transmission of babesiosis, a healthcare acquired infection, has been recognized as an important source of infection and disease and is currently the most frequently reported transfusion acquired disease in the United States. Asymptomatic individuals are difficult to recognize and, therefore, transfusion of blood and blood components collected from them may result in transfusion-transmitted babesiosis (TTB), leading to potentially fatal clinical illness. Babesiosis is associated with significant morbidity and mortality. Increasing numbers of cases of TTB and TTB-associated deaths have been reported in recent years. In July, 2010 the Blood Products AdvisoryCommittee of FDA strongly supported implementation of regional blood donor screening for Babesia microti infection. Currently, no blood donors screening test for babesiosis has been licensed and available diagnostic test formats are not suitable for the high throughput testing required for blood donor screening.

Project Goal:  The goal of this project is the development, validation, and FDA clearance of a high-throughput method for Babesia- specific antibodies with sensitivity and specificity equal to or greater than the existing gold standard method, the indirect immunofluorescence antibody assay, which is labor intensive and not suitable for high throughput blood donor screening. An effective and feasible test must be compatible with existing blood donor screening platforms, which require rapid results and flexibility to accommodate large numbers of samples tested simultaneously. Other innovative non serological approaches that can be easily integrated into existing blood donor screening platforms and workflows would also be considered. All submissions must include validation and FDA clearance as deliverables.

Impact:  Reliable blood donor screening for babesiosis will prevent transmission by transfusion and decrease the number of deaths attributable to this healthcare acquired disease. This would preserve the blood supply since other options for controlof this transfusion transmissible disease include stopping blood collections in risk areas for months when tick-borne transmission is occurring. Introduction of blood donor screening for babesiosis will help improve blood safety and prevent healthcare acquired disease, in keeping with CDC’s goals. CDC will collaborate with test developers to validate tools in the field and to disseminate new technologies.

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