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Preventing transfusion-transmitted babesiosis: preliminary experience of the first laboratory-based blood donor screening program

Authors

  • Carolyn Young,

    Corresponding author
    1. From the Department of Administration and Laboratory Department, Rhode Island Blood Center, and the Department of Hematology-Oncology, Hasbro Children's Hospital of Rhode Island, Providence, Rhode Island; the Research and Reference Divisions, Imugen, Inc., Norwood, Massachusetts; the Department of Pediatrics and Department of Pathology, Women & Infants Hospital, and the Division of Infectious Disease, Roger Williams Medical Center, Providence, Rhode Island; Yale School of Public Health and Yale School of Medicine, New Haven, Connecticut; and Rhode Island Hospital, Division of Infectious Diseases; Department of Medicine, Warren Alpert Medical School of Brown University, Providence, Rhode Island.
      Carolyn Young, MD, Rhode Island Blood Center, 405 Promenade Street, Providence, RI 02908; e-mail: cyoung@ribc.org.
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  • Anjulika Chawla,

    1. From the Department of Administration and Laboratory Department, Rhode Island Blood Center, and the Department of Hematology-Oncology, Hasbro Children's Hospital of Rhode Island, Providence, Rhode Island; the Research and Reference Divisions, Imugen, Inc., Norwood, Massachusetts; the Department of Pediatrics and Department of Pathology, Women & Infants Hospital, and the Division of Infectious Disease, Roger Williams Medical Center, Providence, Rhode Island; Yale School of Public Health and Yale School of Medicine, New Haven, Connecticut; and Rhode Island Hospital, Division of Infectious Diseases; Department of Medicine, Warren Alpert Medical School of Brown University, Providence, Rhode Island.
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  • Victor Berardi,

    1. From the Department of Administration and Laboratory Department, Rhode Island Blood Center, and the Department of Hematology-Oncology, Hasbro Children's Hospital of Rhode Island, Providence, Rhode Island; the Research and Reference Divisions, Imugen, Inc., Norwood, Massachusetts; the Department of Pediatrics and Department of Pathology, Women & Infants Hospital, and the Division of Infectious Disease, Roger Williams Medical Center, Providence, Rhode Island; Yale School of Public Health and Yale School of Medicine, New Haven, Connecticut; and Rhode Island Hospital, Division of Infectious Diseases; Department of Medicine, Warren Alpert Medical School of Brown University, Providence, Rhode Island.
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  • James Padbury,

    1. From the Department of Administration and Laboratory Department, Rhode Island Blood Center, and the Department of Hematology-Oncology, Hasbro Children's Hospital of Rhode Island, Providence, Rhode Island; the Research and Reference Divisions, Imugen, Inc., Norwood, Massachusetts; the Department of Pediatrics and Department of Pathology, Women & Infants Hospital, and the Division of Infectious Disease, Roger Williams Medical Center, Providence, Rhode Island; Yale School of Public Health and Yale School of Medicine, New Haven, Connecticut; and Rhode Island Hospital, Division of Infectious Diseases; Department of Medicine, Warren Alpert Medical School of Brown University, Providence, Rhode Island.
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  • Gail Skowron,

    1. From the Department of Administration and Laboratory Department, Rhode Island Blood Center, and the Department of Hematology-Oncology, Hasbro Children's Hospital of Rhode Island, Providence, Rhode Island; the Research and Reference Divisions, Imugen, Inc., Norwood, Massachusetts; the Department of Pediatrics and Department of Pathology, Women & Infants Hospital, and the Division of Infectious Disease, Roger Williams Medical Center, Providence, Rhode Island; Yale School of Public Health and Yale School of Medicine, New Haven, Connecticut; and Rhode Island Hospital, Division of Infectious Diseases; Department of Medicine, Warren Alpert Medical School of Brown University, Providence, Rhode Island.
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  • Peter J. Krause,

    1. From the Department of Administration and Laboratory Department, Rhode Island Blood Center, and the Department of Hematology-Oncology, Hasbro Children's Hospital of Rhode Island, Providence, Rhode Island; the Research and Reference Divisions, Imugen, Inc., Norwood, Massachusetts; the Department of Pediatrics and Department of Pathology, Women & Infants Hospital, and the Division of Infectious Disease, Roger Williams Medical Center, Providence, Rhode Island; Yale School of Public Health and Yale School of Medicine, New Haven, Connecticut; and Rhode Island Hospital, Division of Infectious Diseases; Department of Medicine, Warren Alpert Medical School of Brown University, Providence, Rhode Island.
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  • the Babesia Testing Investigational Containment Study Group


  • The Babesia Testing Investigational Containment Study Group consists of Paul Cislo, Tassos Kyriakides, Darlene Folan, Paul Durda, W. Dwayne Lawrence, and Leonard Mermel.

  • This study was made possible in part through the gift of the Gordon and Llura Gund Foundation.

Carolyn Young, MD, Rhode Island Blood Center, 405 Promenade Street, Providence, RI 02908; e-mail: cyoung@ribc.org.

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.

STUDY DESIGN AND 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).

CONCLUSION: 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.

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