{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,26]],"date-time":"2026-02-26T20:59:20Z","timestamp":1772139560547,"version":"3.50.1"},"reference-count":28,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2018,4,17]],"date-time":"2018-04-17T00:00:00Z","timestamp":1523923200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"name":"intramural FDA grants"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Transfusion"],"published-print":{"date-parts":[[2018,8]]},"abstract":"<jats:sec><jats:title>BACKGROUND<\/jats:title><jats:p>Babesiosis is a zoonotic disease transmitted to humans by the bite of infected ticks and caused by apicomplexan parasites, most commonly <jats:italic>Babesia microti<\/jats:italic>. Additionally, blood and blood products collected from asymptomatically infected blood donors may cause transfusion\u2010transmitted infections in recipients. Highly sensitive molecular assays that detect parasite nucleic acid are needed for laboratory diagnosis and to identify and defer clinically silent but parasitemic blood donors.<\/jats:p><\/jats:sec><jats:sec><jats:title>STUDY DESIGN AND METHODS<\/jats:title><jats:p>Here we report the development and analytical and clinical characterization of a real\u2010time polymerase chain reaction (RT\u2010PCR)\u2013based assay for the detection of <jats:italic>B.\u00a0microti<\/jats:italic> genomic DNA in whole blood. We evaluate the detection of <jats:italic>Babesia<\/jats:italic> parasites using two separate targets, the traditional18S ribosomal subunit gene (<jats:italic>Bm<\/jats:italic>18S) and members of the abundant BMN family of seroreactive antigens (<jats:italic>Bm<\/jats:italic>BMN).<\/jats:p><\/jats:sec><jats:sec><jats:title>RESULTS<\/jats:title><jats:p>Analytical sensitivity determination using a probit analysis demonstrated an analytical sensitivity of 30.9 parasites\/mL for 18S amplification and 10.0 parasites\/mL for BMN amplification The BMN primer set also demonstrates superior sensitivity for serial dilution panels prepared from clinically diagnosed <jats:italic>Babesia<\/jats:italic>\u2010infected blood samples, generally detecting 10\u2010fold more dilute nucleic acid.<\/jats:p><\/jats:sec><jats:sec><jats:title>CONCLUSIONS<\/jats:title><jats:p>Cumulatively, our data demonstrate that RT\u2010PCR detection of the BMN family of seroreactive antigens reflects a sensitive and superior assay for the detection of <jats:italic>B.\u00a0microti<\/jats:italic> in whole blood samples.<\/jats:p><\/jats:sec>","DOI":"10.1111\/trf.14642","type":"journal-article","created":{"date-parts":[[2018,4,17]],"date-time":"2018-04-17T11:44:10Z","timestamp":1523965450000},"page":"1924-1932","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":15,"title":["Superior real\u2010time polymerase chain reaction detection of <i>Babesia microti<\/i> parasites in whole blood utilizing high\u2010copy BMN antigens as amplification targets"],"prefix":"10.1111","volume":"58","author":[{"given":"Bryan","family":"Grabias","sequence":"first","affiliation":[{"name":"Division of Emerging and Transfusion Transmitted Diseases Office of Blood Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration Silver Spring Maryland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jean","family":"Clement","sequence":"additional","affiliation":[{"name":"Division of Emerging and Transfusion Transmitted Diseases Office of Blood Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration Silver Spring Maryland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peter J.","family":"Krause","sequence":"additional","affiliation":[{"name":"Yale School of Public Health and Yale School of Medicine New Haven Connecticut"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Timothy","family":"Lepore","sequence":"additional","affiliation":[{"name":"Nantucket Cottage Hospital Nantucket Massachusetts"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sanjai","family":"Kumar","sequence":"additional","affiliation":[{"name":"Division of Emerging and Transfusion Transmitted Diseases Office of Blood Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration Silver Spring Maryland"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2018,4,17]]},"reference":[{"key":"e_1_2_6_2_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMra1202018"},{"key":"e_1_2_6_3_1","first-page":"505","article-title":"Babesiosis surveillance\u201418 States, 2011","volume":"61","author":"Centers for Disease Control & Prevention","year":"2012","journal-title":"MMWR"},{"key":"e_1_2_6_4_1","first-page":"669","article-title":"Final 2012 reports of nationally notifiable infectious diseases","volume":"62","author":"Centers for Disease Control & Prevention","year":"2013","journal-title":"MMWR"},{"key":"e_1_2_6_5_1","first-page":"702","article-title":"Final 2013 reports of nationally notifiable infectious diseases","volume":"63","author":"Centers for Disease Control & Prevention","year":"2014","journal-title":"MMWR"},{"key":"e_1_2_6_6_1","first-page":"1019","article-title":"Final 2014 reports of nationally notifiable infectious diseases","volume":"64","author":"Centers for Disease Control & Prevention","year":"2015","journal-title":"MMWR"},{"key":"e_1_2_6_7_1","doi-asserted-by":"publisher","DOI":"10.3201\/eid2002.130644"},{"key":"e_1_2_6_8_1","doi-asserted-by":"publisher","DOI":"10.1086\/525852"},{"key":"e_1_2_6_9_1","doi-asserted-by":"publisher","DOI":"10.4269\/ajtmh.2003.68.431"},{"key":"e_1_2_6_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1537-2995.2009.02380.x"},{"key":"e_1_2_6_11_1","doi-asserted-by":"publisher","DOI":"10.1086\/595010"},{"key":"e_1_2_6_12_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1537-2995.2009.02317.x"},{"key":"e_1_2_6_13_1","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-155-8-201110180-00362"},{"key":"e_1_2_6_14_1","unstructured":"Food and Drug Administration.Biological product deviations annual summary [Internet].Silver Spring (MD):CBER;2010\u20102014 [cited 2018 Apr 9]. 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