title: Preventing transfusion-transmitted babesiosis: preliminary experience of the first laboratory-based blood donor screening program.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Administration and Laboratory Department, Rhode Island Blood Center, RI, USA. cyoung@ribc.org
authors.forename: Carolyn
authors.initials: C
authors.lastname: Young
authors.forename: Anjulika
authors.initials: A
authors.lastname: Chawla
authors.forename: Victor
authors.initials: V
authors.lastname: Berardi
authors.forename: James
authors.initials: J
authors.lastname: Padbury
authors.forename: Gail
authors.initials: G
authors.lastname: Skowron
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Krause
mesh_terms: D000293:Adolescent; D000328:Adult; D041001:Babesia microti; D001404:Babesiosis / Q000097:blood* / Q000517:prevention & control* / Q000635:transmission; D001782:Blood Donors; D001803:Blood Transfusion; D046148:Donor Selection / Q000379:methods*; D005260:Female; D019084:Fluorescent Antibody Technique, Indirect / Q000379:methods; D006801:Humans; D008297:Male; D008875:Middle Aged; D060888:Real-Time Polymerase Chain Reaction / Q000379:methods