{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T22:18:25Z","timestamp":1790806705849,"version":"4.1.0"},"reference-count":40,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2016,5,25]],"date-time":"2016-05-25T00:00:00Z","timestamp":1464134400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100008495","name":"Blood Systems Research Institute","doi-asserted-by":"publisher","award":["10734"],"award-info":[{"award-number":["10734"]}],"id":[{"id":"10.13039\/100008495","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Transfusion"],"published-print":{"date-parts":[[2016,7]]},"abstract":"<jats:sec><jats:title>BACKGROUND<\/jats:title><jats:p>The tick\u2010borne pathogen <jats:italic>Babesia microti<\/jats:italic> has become recognized as the leading infectious risk associated with blood transfusion in the United States, yet no Food and Drug Administration\u2013licensed screening tests are currently available to mitigate this risk. The aim of this study was to evaluate the performance of an investigational enzyme immunoassay (EIA) for <jats:italic>B. microti<\/jats:italic> as a screening test applied to endemic and nonendemic blood donor populations.<\/jats:p><\/jats:sec><jats:sec><jats:title>STUDY DESIGN AND METHODS<\/jats:title><jats:p>The study aimed to test 20,000 blood donors from areas of the United States considered endemic for <jats:italic>B. microti<\/jats:italic> and 10,000 donors from a nonendemic area with the investigational <jats:italic>B. microti<\/jats:italic> EIA. Repeat\u2010reactive samples were retested by polymerase chain reaction (PCR), blood smear, immunofluorescent assay (IFA), and immunoblot assay. In parallel, serum samples from symptomatic patients with confirmed babesiosis were tested by EIA, IFA, and immunoblot assays.<\/jats:p><\/jats:sec><jats:sec><jats:title>RESULTS<\/jats:title><jats:p>A total of 38 of 13,757 (0.28%) of the donors from New York, 7 of 4583 (0.15%) from Minnesota, and 11 of 8363 (0.13%) from New Mexico were found repeat reactive by EIA. Nine of the 56 EIA repeat\u2010reactive donors (eight from New York and one from Minnesota) were positive by PCR. The specificity of the assay in a nonendemic population was 99.93%. Among IFA\u2010positive clinical babesiosis patients, the sensitivity of the assay was 91.1%.<\/jats:p><\/jats:sec><jats:sec><jats:title>CONCLUSION<\/jats:title><jats:p>The <jats:italic>B. microti<\/jats:italic> EIA detected PCR\u2010positive, potentially infectious blood donors in an endemic population and exhibited high specificity among uninfected and unexposed individuals. The EIA promises to provide an effective tool for blood donor screening for <jats:italic>B. microti<\/jats:italic> in a format amenable to high\u2010throughput and cost\u2010effective screening.<\/jats:p><\/jats:sec>","DOI":"10.1111\/trf.13618","type":"journal-article","created":{"date-parts":[[2016,5,25]],"date-time":"2016-05-25T19:42:04Z","timestamp":1464205324000},"page":"1866-1874","source":"Crossref","is-referenced-by-count":34,"title":["Serologic screening of United States blood donors for <i>Babesia microti<\/i> using an investigational enzyme immunoassay"],"prefix":"10.1111","volume":"56","author":[{"given":"Andrew E.","family":"Levin","sequence":"first","affiliation":[{"name":"Immunetics, Inc. 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