Determination of Babesia microti seroprevalence in blood donor populations using an investigational enzyme immunoassay. Issue 9 (4th July 2014)

• Record Type: Journal Article
• Authors: Levin, Andrew E.; Williamson, Phillip C.; Erwin, James L.; Cyrus, Sherri; Bloch, Evan M.; Shaz, Beth H.; Kessler, Debra; Telford, Sam R.; Krause, Peter J.; Wormser, Gary P.; Ni, Xiaoyan; Wang, Haihong; Krueger, Neil X.; Caglioti, Sally; Busch, Michael P.
• Is Part Of: Transfusion. Volume 54:Issue 9(2014)
• Page Start: 2237
• Page End: 2244
• Publication Date: 2014-07-04
• Subjects: Hematology -- Periodicals; Blood -- Transfusion -- Periodicals; Blood Group Antigens -- Periodicals; Blood Preservation -- Periodicals; Blood Transfusion -- Periodicals; 615
• DOI: 10.1111/trf.12763
• Languages: English
• ISSNs: 0041-1132

Abstract

<abstract abstract-type="main"> <title> <x xml:space="preserve">Abstract</x> </title> <sec id="trf12763-sec-0001" sec-type="section"> <title>Background</title> <p>Transfusion‐transmitted babesiosis caused by <italic>Babesia microti</italic> has emerged as a significant risk to the US blood supply. This study estimated the prevalence of <italic>B. microti</italic> antibodies in blood donors using an investigational enzyme immunoassay (EIA).</p> </sec> <sec id="trf12763-sec-0002" sec-type="section"> <title>Study Design and Methods</title> <p>A peptide‐based EIA that detects both immunoglobulin (Ig)G and IgM antibodies to <italic>B. microti</italic> was developed and validated. Donor samples randomly selected from areas defined as high‐risk endemic, lower‐risk endemic, and nonendemic for <italic>B. microti</italic> were deidentified and tested using the investigational EIA. Samples that were EIA repeat reactive were further tested by <italic>B. microti</italic> 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.</p> </sec> <sec id="trf12763-sec-0003" sec-type="section"> <title>Results</title> <p>Among 15, 000 donations tested with the investigational <italic>B. microti</italic> 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.</p> </sec> <sec id="trf12763-sec-0004" sec-type="section"> <title>Conclusion</title> <p>The seroprevalence of <italic>B. microti</italic> 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 <italic>B. microti</italic>.</p> </sec> </abstract>