Determination of Babesia microti seroprevalence in blood donor populations using an investigational enzyme immunoassay

Andrew E Levin, Phillip C Williamson, James L Erwin, Sherri Cyrus, Evan M Bloch, Beth H Shaz, Debra Kessler, Sam R Telford 3rd, Peter J Krause, Gary P Wormser, Xiaoyan Ni, Haihong Wang, Neil X Krueger, Sally Caglioti, Michael P Busch, Andrew E Levin, Phillip C Williamson, James L Erwin, Sherri Cyrus, Evan M Bloch, Beth H Shaz, Debra Kessler, Sam R Telford 3rd, Peter J Krause, Gary P Wormser, Xiaoyan Ni, Haihong Wang, Neil X Krueger, Sally Caglioti, Michael P Busch

Abstract

Background: Transfusion-transmitted babesiosis caused by Babesia microti has emerged as a significant risk to the US blood supply. This study estimated the prevalence of B. microti antibodies in blood donors using an investigational enzyme immunoassay (EIA).

Study design and methods: A peptide-based EIA that detects both immunoglobulin (Ig)G and IgM antibodies to B. microti was developed and validated. Donor samples randomly selected from areas defined as high-risk endemic, lower-risk endemic, and nonendemic for B. microti were deidentified and tested using the investigational EIA. Samples that were EIA repeat reactive were further tested by B. microti immunofluorescent assay (IFA), polymerase chain reaction (PCR) on red blood cell lysates, and peripheral blood smear examination. A random subset of 1272 samples from high-risk endemic areas was tested by IFA, PCR, and peripheral blood smear in parallel with EIA.

Results: Among 15,000 donations tested with the investigational B. microti EIA, EIA repeat-reactive rates were 1.08% (54/5000) in a high-risk endemic area, 0.74% (37/5000) in a lower-risk area, and 0.40% (20/5000) in a nonendemic area. After application of a revised cutoff, these values were reduced to 0.92%, (46/5000), 0.54% (27/5000), and 0.16% (8/5000). Overall concordance between EIA and IFA among donor samples was 99.34%. One seropositive sample was positive by PCR.

Conclusion: The seroprevalence of B. microti in blood donors in a high-risk area measured by an investigational EIA was approximately 1%. The EIA shows promise as an efficient high-throughput blood donor screening assay for B. microti.

© 2014 The Authors. Transfusion published by Wiley Periodicals, Inc. on behalf of AABB.

Figures

Figure 1
Figure 1
Flow charts showing the two arms of the study. Numbers in parentheses represent numbers of samples at each stage. RR = repeat reactive.
Figure 2
Figure 2
Distribution of S/CO values in the B. microti EIA for healthy blood donors from a non-endemic area (⋄, n = 1003), clinical babesiosis patients that were positive by IFA at 1:64 (□, n = 72), and blood donors from a high-risk endemic area that were EIA repeat reactive or repeat gray zone (n = 69), subdivided between IFA-positive (△, n = 19) and IFA-negative (○, n = 50) groups. The original EIA cutoff is shown as a horizontal dashed line.

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