{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,29]],"date-time":"2026-07-29T20:26:34Z","timestamp":1785356794508,"version":"3.55.0"},"reference-count":31,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2021,8,8]],"date-time":"2021-08-08T00:00:00Z","timestamp":1628380800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100006665","name":"ARC of the Piedmont","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100006665","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Transfusion"],"published-print":{"date-parts":[[2021,10]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Human babesiosis is a zoonotic infection caused by an intraerythrocytic parasite. The highest incidence of babesiosis is in the United States, although cases have been reported in other parts of the world. Due to concerns of transfusion\u2010transmitted babesiosis<jats:italic>,<\/jats:italic> the US Food and Drug Administration (FDA) recommended year\u2010round regional testing for <jats:italic>Babesia<\/jats:italic> by nucleic acid testing or use of an FDA\u2010approved device for pathogen reduction. A new molecular test, cobas Babesia (Roche Molecular Systems, Inc.), was evaluated for the detection of the four species that cause human disease, <jats:italic>Babesia microti<\/jats:italic>, <jats:italic>Babesia duncani<\/jats:italic>, <jats:italic>Babesia divergens<\/jats:italic>, and <jats:italic>Babesia venatorum<\/jats:italic>.<\/jats:p><\/jats:sec><jats:sec><jats:title>Study design and methods<\/jats:title><jats:p>Analytical performance was evaluated followed by clinical studies on whole blood samples from US blood donations collected in a special tube containing a chaotropic reagent that lyses the red cells and preserves nucleic acid. Sensitivity and specificity of the test in individual samples (individual donation testing [IDT]) and in pools of six donations were determined.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Based on analytical studies, the claimed limit of detection of cobas Babesia for <jats:italic>B. microti<\/jats:italic> is 6.1 infected red blood cells (iRBC)\/mL (95% confidence interval [CI]: 5.0, 7.9); <jats:italic>B. duncani<\/jats:italic> was 50.2 iRBC\/mL (95% CI: 44.2, 58.8); <jats:italic>B. divergens<\/jats:italic> was 26.1 (95% CI: 22.3, 31.8); and <jats:italic>B. venatorum<\/jats:italic> was 40.0 iRBC\/mL (95% CI: 34.1, 48.7). The clinical specificity for IDT was 99.999% (95% CI: 99.996, 100) and 100% (95% CI: 99.987, 100) for pools of six donations.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>cobas Babesia enables donor screening for <jats:italic>Babesia<\/jats:italic> species with high sensitivity and specificity.<\/jats:p><\/jats:sec>","DOI":"10.1111\/trf.16617","type":"journal-article","created":{"date-parts":[[2021,8,8]],"date-time":"2021-08-08T19:15:30Z","timestamp":1628450130000},"page":"2969-2980","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":24,"title":["Detection of <i>Babesia<\/i><scp>RNA<\/scp> and <scp>DNA<\/scp> in whole blood samples from <scp>US<\/scp> blood donations"],"prefix":"10.1111","volume":"61","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9182-9281","authenticated-orcid":false,"given":"Jean","family":"Stanley","sequence":"first","affiliation":[{"name":"Clinical Development and Medical Affairs Roche Molecular Systems, Inc.  Pleasanton California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5865-6366","authenticated-orcid":false,"given":"Susan L.","family":"Stramer","sequence":"additional","affiliation":[{"name":"Scientific Services American Red Cross  Gaithersburg Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yasuko","family":"Erickson","sequence":"additional","affiliation":[{"name":"Medical Affairs ImpactLife  Davenport Iowa USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julie","family":"Cruz","sequence":"additional","affiliation":[{"name":"Medical Science Institute Versiti Blood Center  Indianapolis Indiana USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jed","family":"Gorlin","sequence":"additional","affiliation":[{"name":"Physician Services Innovative Blood Resources  St. Paul Minnesota USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark","family":"Janzen","sequence":"additional","affiliation":[{"name":"Laboratory Services Innovative Blood Resources, St. Paul  Minnesota USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susan N.","family":"Rossmann","sequence":"additional","affiliation":[{"name":"Medical Services Gulf Coast Regional Blood Center  Houston Texas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Todd","family":"Straus","sequence":"additional","affiliation":[{"name":"Medical Services The Community Blood Center  Appleton Wisconsin USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patrick","family":"Albrecht","sequence":"additional","affiliation":[{"name":"Assay Development Roche Diagnostics International Ltd  Rotkreuz Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lisa Lee","family":"Pate","sequence":"additional","affiliation":[{"name":"Clinical Development and Medical Affairs Roche Molecular Systems, Inc.  Pleasanton California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susan A.","family":"Galel","sequence":"additional","affiliation":[{"name":"Clinical Development and Medical Affairs Roche Molecular Systems, Inc.  Pleasanton California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"the cobas Babesia IND study group","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2021,8,8]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijpara.2018.11.007"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMra1202018"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.idc.2015.02.008"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jemermed.2018.12.044"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1093\/jpids\/pix074"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-155-8-201110180-00362"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.tmrv.2016.04.002"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1111\/trf.14476"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/tid.12830"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.3201\/eid1701.100737"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.3201\/eid2208.150195"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1007\/s15010-013-0526-8"},{"key":"e_1_2_8_14_1","first-page":"509","article-title":"Human babesiosis, an emerging tick\u2010borne disease in the People's Republic of China","volume":"7","author":"Zhou X","year":"2014","journal-title":"Parasit Vectors"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.1097\/MOH.0000000000000606"},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00436-019-06250-9"},{"key":"e_1_2_8_17_1","doi-asserted-by":"publisher","DOI":"10.3201\/eid2604.200025"},{"key":"e_1_2_8_18_1","volume-title":"Surveillance for babesiosis \u2014 United States, 2017 Annual Summary.","author":"Centers for Disease Control and Prevention (CDC)","year":"2019"},{"key":"e_1_2_8_19_1","doi-asserted-by":"publisher","DOI":"10.1111\/trf.15425"},{"key":"e_1_2_8_20_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1537-2995.2011.03467.x"},{"key":"e_1_2_8_21_1","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/cix216"},{"key":"e_1_2_8_22_1","volume-title":"Guidance for industry: recommendations for reducing the risk of transfusion\u2010transmitted Babesiosis","author":"US Food and Drug Administration","year":"2019"},{"key":"e_1_2_8_23_1","unstructured":"cobas Babesia nucleic acid test for use on the cobas 6800\/8800 Systems; 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