Article

Transfusion-transmitted babesiosis in the United States: summary of a workshop.

Office of Blood Research and Review, Center for Biologics Evaluation and Research, US Food and Drug Administration, Rockville, Maryland 20852, USA.
Transfusion (Impact Factor: 3.57). 10/2009; 49(12):2759-71. DOI: 10.1111/j.1537-2995.2009.02429.x
Source: PubMed

ABSTRACT Infections of humans with intraerythrocytic parasites of the genus Babesia can be locally prevalent in diverse regions of the United States. Transfusion of blood and blood products collected from donors infected with Babesia may result in a serious illness that can be fatal. In September 2008, the Food and Drug Administration organized a public workshop to discuss the various aspects of transfusion-transmitted babesiosis in the United States including the possible strategies to identify and defer blood donors who may have been infected with Babesia. Discussions were also held on the biology, pathogenesis, and epidemiology of Babesia species. In this article, we summarize the scientific presentations and panel discussions that took place during the workshop.

0 Bookmarks
 · 
113 Views
  • [Show abstract] [Hide abstract]
    ABSTRACT: Babesiosis is a potentially life-threatening disease caused by intraerythrocytic parasites, which usually are tickborne but also are transmissible by transfusion. Tickborne transmission of Babesia microti mainly occurs in 7 states in the Northeast and the upper Midwest of the United States. No Babesia test for screening blood donors has been licensed. To ascertain and summarize data on U.S. transfusion-associated Babesia cases identified since the first described case in 1979. Case series. United States. Case patients were transfused during 1979-2009 and had posttransfusion Babesia infection diagnosed by 2010, without reported evidence that another transmission route was more likely than transfusion. Implicated donors had laboratory evidence of infection. Potential cases were excluded if all pertinent donors tested negative. Distributions of ascertained cases according to Babesia species and period and state of transfusion. 159 transfusion-associated B. microti cases were included; donors were implicated for 136 (86%). The case patients' median age was 65 years (range, <1 to 94 years). Most cases were associated with red blood cell components; 4 were linked to whole blood-derived platelets. Cases occurred in all 4 seasons and in 22 (of 31) years, but 77% (122 cases) occurred during 2000-2009. Cases occurred in 19 states, but 87% (138 cases) were in the 7 main B. microti-endemic states. In addition, 3 B. duncani cases were documented in western states. The extent to which cases were not diagnosed, investigated, reported, or ascertained is unknown. Donor-screening strategies that mitigate the risk for transfusion transmission are needed. Babesiosis should be included in the differential diagnosis of unexplained posttransfusion hemolytic anemia or fever, regardless of the season or U.S. region. None.
    Annals of internal medicine 09/2011; 155(8):509-19. · 16.10 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: We review here 7 cases of neonatal transfusion-associated babesiosis at a NICU in the northeast United States. Transfusion from 2 infected units of blood resulted in the 7 cases described. The clinical presentation was highly variable in this cohort; the extremely low birth weight neonates were the most severely affected. Antibiotic therapy was effective in neonates with mild and asymptomatic infection; however, double-volume exchange blood transfusion with prolonged multidrug treatment was required for the 2 most severe cases. The risk of Babesia microti infection is not eliminated through current blood-bank practices. Neonatologists in endemic areas should have a high index of suspicion for babesiosis in premature infants exposed to blood transfusions.
    PEDIATRICS 09/2011; 128(4):e1019-24. · 5.30 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: Babesiosis is the most common transfusion-transmitted infection reported to the Food and Drug Administration (FDA). We developed and implemented the first laboratory-based blood donor screening program for Babesia microti to help reduce and prevent transfusion-transmitted babesiosis (TTB) and report results for the initial year. Selective B. microti donor screening was performed using real-time polymerase chain reaction (PCR) and indirect immunofluorescence assay (IFA) to reduce the incidence of TTB in neonates and pediatric sickle cell and thalassemia patients under an FDA-approved investigational new drug application. We compared the reports of TTB in these patients in the first 12 months of the study with those of patients who received unscreened blood from 2005 to 2010. There were 2113 units tested with 2086 negative results, 26 positive IFA results (1.23%), and one indeterminate PCR result (0.05%). No reported case of TTB occurred with any B. microti-screened unit transfused to the targeted patients (0/787 units) or to any patient who received the screened units (0/2086 units). Before screening, there were seven cases of TTB in neonates, sickle cell, and thalassemia patients from 6500 unscreened units (one case/929 units) and 24 cases in the total transfused population from 496,545 units distributed (one case/20,686 units). Implementation of B. microti IFA and PCR screening is compatible with blood center operations to provide tested units. While the results after 1 year are not powered to demonstrate a change in the rate of TTB after testing, they are encouraging.
    Transfusion 03/2012; 52(7):1523-9. · 3.57 Impact Factor