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- Title
A prospective evaluation of chronic Babesia microti infection in seroreactive blood donors.
- Authors
Bloch, Evan M.; Levin, Andrew E.; Williamson, Phillip C.; Cyrus, Sherri; Shaz, Beth H.; Kessler, Debra; Gorlin, Jed; Bruhn, Roberta; Lee, Tzong‐Hae; Montalvo, Leilani; Kamel, Hany; Busch, Michael P.
- Abstract
<bold>Background: </bold>Babesia microti is the foremost infectious risk to the US blood supply for which a Food and Drug Administration (FDA)-licensed test is unavailable for donation screening. Characterization of the antibody response to B. microti and correlation with parasitemia is necessary to guide screening and donor management policies.<bold>Study Design and Methods: </bold>During an FDA licensure trial, blood donors were prospectively screened (July-November 2013) using a B. microti-specific antibody enzyme immunoassay (EIA, Immunetics) in highly endemic (New York [NY]; n = 13,688), moderately endemic (Minnesota [MN]; n = 4583), and nonendemic (New Mexico [NM]; n = 8451) regions. Blood donors with repeat-reactive (RR) results participated in a 12-month prospective cohort study using B. microti EIA, immunofluorescent assay, polymerase chain reaction (PCR), blood smear, and clinical questionnaire.<bold>Results: </bold>Thirty-seven (61.67%; 24 NY, seven MN, six NM) of 60 eligible RR donors enrolled in the study; 20 of 37 (54%) completed the 12-month follow-up visit of which 15 (75%) were still seroreactive. Nine PCR-positive donors were identified during index screening; five participated in the follow-up study, three were PCR positive at 6 months, and two remained positive at final follow-up (378 and 404 days). Most RR donors displayed low-level seroreactivity that was either stable or waning during follow-up. The level and pattern of reactivity correlated poorly with PCR positivity.<bold>Conclusion: </bold>The findings indicate prolonged seropositivity in blood donors. Although rare, asymptomatic, persistent PCR positivity supports the current policy of indefinite deferral for donors with a history of babesiosis or positive test results. Repeat testing by PCR and serology will be necessary if reinstatement is to be considered.
- Subjects
BABESIA; VOLES; BLOOD transfusion reaction; BLOOD donors; INFECTION risk factors; DISEASES; BABESIOSIS diagnosis; BABESIOSIS; CLINICAL trials; IMMUNOENZYME technique; IMMUNOGLOBULINS; LONGITUDINAL method; MEDICAL screening; POLYMERASE chain reaction; RESEARCH funding; SERODIAGNOSIS
- Publication
Transfusion, 2016, Vol 56, Issue 7, p1875
- ISSN
0041-1132
- Publication type
journal article
- DOI
10.1111/trf.13617