BACKGROUND: 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. STUDY DESIGN AND METHODS: 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. RESULTS: 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. CONCLUSION: 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.
BACKGROUND: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. STUDY DESIGN AND METHODS: 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. RESULTS: 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. CONCLUSION: 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.
Authors: David A Leiby; Amy P S Chung; Ritchard G Cable; Jonathan Trouern-Trend; Jeffrey McCullough; Mary J Homer; Lisa D Reynolds; Raymond L Houghton; Michael J Lodes; David H Persing Journal: Transfusion Date: 2002-12 Impact factor: 3.157
Authors: Erin D Moritz; Colleen S Winton; Stephanie T Johnson; David E Krysztof; Rebecca L Townsend; Gregory A Foster; Patricia Devine; Philip Molloy; Edward Brissette; Victor P Berardi; Susan L Stramer Journal: Transfusion Date: 2014-05-28 Impact factor: 3.157
Authors: David A Leiby; Amy P S Chung; Jennifer E Gill; Raymond L Houghton; David H Persing; Stanley Badon; Ritchard G Cable Journal: Transfusion Date: 2005-11 Impact factor: 3.157
Authors: Caroline B Yancey; Barbara C Hegarty; Barbara A Qurollo; Michael G Levy; Adam J Birkenheuer; David J Weber; Pedro P V P Diniz; Edward B Breitschwerdt Journal: Vector Borne Zoonotic Dis Date: 2014-10 Impact factor: 2.133
Authors: Barbara L Herwaldt; Jeanne V Linden; Elizabeth Bosserman; Carolyn Young; Danuta Olkowska; Marianna Wilson Journal: Ann Intern Med Date: 2011-09-05 Impact factor: 25.391
Authors: Andrew E Levin; Phillip C Williamson; James L Erwin; Sherri Cyrus; Evan M Bloch; Beth H Shaz; Debra Kessler; Sam R Telford; Peter J Krause; Gary P Wormser; Xiaoyan Ni; Haihong Wang; Neil X Krueger; Sally Caglioti; Michael P Busch Journal: Transfusion Date: 2014-07-04 Impact factor: 3.157
Authors: Sini Skariah; Paul Arnaboldi; Raymond J Dattwyler; Ali A Sultan; Corey Gaylets; Odaelys Walwyn; Hannah Mulhall; Xia Wu; Soha R Dargham; Dana G Mordue Journal: J Immunol Date: 2017-06-12 Impact factor: 5.422
Authors: Evan M Bloch; Zakayo Mrango; Mabula Kasubi; Jerusha Weaver; Aleksandra Mihailovic; Beatriz Munoz; Anna Weimer; Andrew Levin; Laura Tonnetti; Jeffrey M Linnen; Vanessa Brès; Douglas E Norris; Giovanna Carpi; Sheila K West Journal: PLoS Negl Trop Dis Date: 2019-08-14
Authors: Kevin Cheng; Kelly E Coller; Christopher C Marohnic; Zachary A Pfeiffer; James R Fino; Randee R Elsing; Janet Bergsma; Marilee A Marcinkus; Alak K Kar; Orlando H Gumbs; Kathy S Otis; Jeffrey Fishpaugh; Phillip W Schultz; Mark R Pope; Alfredo R Narvaez; Susan J Wong; Susan Madison-Antenucci; Thomas P Leary; George J Dawson Journal: J Clin Microbiol Date: 2018-07-26 Impact factor: 5.948