{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2023,10,1]],"date-time":"2023-10-01T04:09:44Z","timestamp":1696133384453},"reference-count":15,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2016,1,14]],"date-time":"2016-01-14T00:00:00Z","timestamp":1452729600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"name":"Center for Biologics Evaluation and Research of the United States Food and Drug Administration"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Vox Sanguinis"],"published-print":{"date-parts":[[2016,5]]},"abstract":"<jats:sec><jats:title>Background and Objectives<\/jats:title><jats:p>The safety of the blood supply in a number of countries is achieved by interventions that include behaviour\u2010based time\u2010limited or indefinite deferrals and screening of donated units for transfusion\u2010transmitted infections. The relatively high sensitivity of nucleic acid testing (<jats:styled-content style=\"fixed-case\">NAT<\/jats:styled-content>) used in blood donor screening has raised the question of whether such time\u2010based deferrals can be eliminated in favour of individual risk assessment.<\/jats:p><\/jats:sec><jats:sec><jats:title>Materials and Methods<\/jats:title><jats:p>Data on the annual number of incident human immunodeficiency virus (<jats:styled-content style=\"fixed-case\">HIV<\/jats:styled-content>) infections associated with various behaviours and on the performance characteristics of <jats:styled-content style=\"fixed-case\">NAT<\/jats:styled-content> applied to donor screening were used to model the number of potentially infected units that might escape detection in the worst\u2010case scenario in which individual risk assessment was implemented, but was not effective as a screening tool, and donors did not otherwise self\u2010select for lower risk.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>In the absence of effective individual risk\u2010based screening or donor self\u2010selection, the model predicts that in the United States, an additional 39 (95% <jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content> 35\u201343) <jats:styled-content style=\"fixed-case\">HIV<\/jats:styled-content>\u2010infected units would escape detection by nucleic acid testing, potentially capable of exposing approximately 68 (95% <jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content> 61\u201375) individuals to the risk of <jats:styled-content style=\"fixed-case\">HIV<\/jats:styled-content> infection through the administration of prepared blood components.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Despite some inherent uncertainty, the worst\u2010case scenario of completely ineffective individual risk assessment, absence of donor self\u2010selection and increased reliance on <jats:styled-content style=\"fixed-case\">NAT<\/jats:styled-content> for blood screening is estimated to be associated with an approximately fourfold increase in the risk of <jats:styled-content style=\"fixed-case\">HIV<\/jats:styled-content> exposure through transfusion in the United States.<\/jats:p><\/jats:sec>","DOI":"10.1111\/vox.12375","type":"journal-article","created":{"date-parts":[[2016,1,15]],"date-time":"2016-01-15T03:36:01Z","timestamp":1452828961000},"page":"324-328","source":"Crossref","is-referenced-by-count":5,"title":["Modeling complete removal of risk assessment questions in the <scp>USA<\/scp> predicts the risk of <scp>HIV<\/scp> exposure in blood recipients could increase despite the use of nucleic acid testing"],"prefix":"10.1111","volume":"110","author":[{"given":"H.","family":"Yang","sequence":"first","affiliation":[{"name":"Center for Biologics Evaluation and Research US Food and Drug Administration Silver Spring MD USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"S. A.","family":"Anderson","sequence":"additional","affiliation":[{"name":"Center for Biologics Evaluation and Research US Food and Drug Administration Silver Spring MD USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"R.","family":"Forshee","sequence":"additional","affiliation":[{"name":"Center for Biologics Evaluation and Research US Food and Drug Administration Silver Spring MD USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"A.","family":"Williams","sequence":"additional","affiliation":[{"name":"Center for Biologics Evaluation and Research US Food and Drug Administration Silver Spring MD USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"J. S.","family":"Epstein","sequence":"additional","affiliation":[{"name":"Center for Biologics Evaluation and Research US Food and Drug Administration Silver Spring MD USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"P. W.","family":"Marks","sequence":"additional","affiliation":[{"name":"Center for Biologics Evaluation and Research US Food and Drug Administration Silver Spring MD USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2016,1,14]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1537-2995.2010.02851.x"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.tmrv.2011.07.007"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijid.2013.09.016"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1423-0410.2012.01640.x"},{"key":"e_1_2_9_6_1","first-page":"441","article-title":"Changing blood donor screening criteria from permanent deferral for men who have sex with men to individual risk assessment: no evidence of a significant impact on the human immunodeficiency virus epidemic in Italy","volume":"11","author":"Suligoi B","year":"2013","journal-title":"Blood Transfus"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/trf.13247"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1111\/trf.12951"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1537-2995.2005.00649.x"},{"key":"e_1_2_9_10_1","unstructured":"Procleix Ultrio Plus Assay Package Insert 2011.http:\/\/www.fda.gov\/downloads\/BiologicsBloodVaccines\/BloodBloodProducts\/ApprovedProducts\/LicensedProductsBLAs\/BloodDonorScreening\/InfectiousDisease\/UCM335285.pdf[Last accessed 24\/12\/2015]"},{"key":"e_1_2_9_11_1","unstructured":"CDC HIV Surveillance Report.http:\/\/www.cdc.gov\/hiv\/library\/reports\/surveillance\/[Last accessed 28\/8\/2015]"},{"key":"e_1_2_9_12_1","unstructured":"National Blood Collection & Utilization Survey 2011.http:\/\/www.hhs.gov\/ash\/bloodsafety\/nbcus[Last accessed 28\/8\/2015]"},{"key":"e_1_2_9_13_1","first-page":"1335","article-title":"HIV transmission through transfusion \u2013 Missouri and Colorado, 2008","volume":"59","author":"Centers for Disease Control and Prevention","year":"2010","journal-title":"MMWR Morb Mortal Wkly Rep"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.1006\/smim.1993.1018"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1537-2995.2010.02793.x"},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.1111\/trf.12554"}],"container-title":["Vox Sanguinis"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fvox.12375","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/vox.12375","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,30]],"date-time":"2023-09-30T04:18:13Z","timestamp":1696047493000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/vox.12375"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2016,1,14]]},"references-count":15,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2016,5]]}},"alternative-id":["10.1111\/vox.12375"],"URL":"https:\/\/doi.org\/10.1111\/vox.12375","archive":["Portico"],"relation":{},"ISSN":["0042-9007","1423-0410"],"issn-type":[{"value":"0042-9007","type":"print"},{"value":"1423-0410","type":"electronic"}],"subject":[],"published":{"date-parts":[[2016,1,14]]}}}