{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,5]],"date-time":"2026-10-05T11:20:16Z","timestamp":1791199216774,"version":"4.1.0"},"reference-count":34,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2025,5,5]],"date-time":"2025-05-05T00:00:00Z","timestamp":1746403200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100000038","name":"U.S. Food and Drug Administration","doi-asserted-by":"publisher","award":["75F40119P10697"],"award-info":[{"award-number":["75F40119P10697"]}],"id":[{"id":"10.13039\/100000038","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Transfusion"],"published-print":{"date-parts":[[2025,7]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>In 2023, the United States Food and Drug Administration revised its blood donor eligibility policy for men who have sex with men (MSM) from a 3\u2010month deferral to individual assessment. Human Immunodeficiency Virus (<jats:styled-content style=\"fixed-case\">HIV)<\/jats:styled-content> pre\u2010exposure prophylaxis (<jats:styled-content style=\"fixed-case\">PrEP<\/jats:styled-content>) use remains a reason for deferral, and nondisclosure is a concern.<\/jats:p><\/jats:sec><jats:sec><jats:title>Study Design and Methods<\/jats:title><jats:p>In a cross\u2010sectional study of sexually active <jats:styled-content style=\"fixed-case\">MSM<\/jats:styled-content> from 8\u2009U.S. cities who were interested in future blood donation, we assessed the performance of an enzyme\u2010linked immunosorbent assay for detecting tenofovir (<jats:styled-content style=\"fixed-case\">TFV<\/jats:styled-content>) in whole blood (<jats:styled-content style=\"fixed-case\">WB<\/jats:styled-content>) and plasma and the correlation with self\u2010reported <jats:styled-content style=\"fixed-case\">PrEP<\/jats:styled-content> use.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Of 1548 individuals, 48% reported oral <jats:styled-content style=\"fixed-case\">PrEP<\/jats:styled-content> use. The <jats:styled-content style=\"fixed-case\">WB<\/jats:styled-content> assay identified 95% of <jats:styled-content style=\"fixed-case\">PrEP<\/jats:styled-content> users, while the plasma assay detected 88%. The <jats:styled-content style=\"fixed-case\">WB<\/jats:styled-content> assay performed well up to 14\u2009days after the last reported dose. Receiver operating characteristics curve analysis showed an area under the curve of 0.96 (95% confidence interval [<jats:styled-content style=\"fixed-case\">CI]<\/jats:styled-content>: 0.95\u20130.97) using <jats:styled-content style=\"fixed-case\">WB<\/jats:styled-content> and 0.88 (95% <jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content>: 0.86\u20130.90) using plasma. Specificity was 80% for <jats:styled-content style=\"fixed-case\">WB<\/jats:styled-content> and 66% for plasma. Detection rates for TFV disoproxil fumarate\/emtricitabine (FTC) formulations were 99% in <jats:styled-content style=\"fixed-case\">WB<\/jats:styled-content> and 98% in plasma, compared to 93% and 86% for the TFV alafenamide\/FTC formulation.<\/jats:p><\/jats:sec><jats:sec><jats:title>Discussion<\/jats:title><jats:p>High concordance between self\u2010reported oral PrEP use and TFV detection was observed among PrEP users, suggesting the potential utility of WB as a biomatrix for TFV detection to support screening strategies. Given the expanded eligibility for MSM, who may be PrEP users, to donate blood, further examination of undisclosed PrEP use is important.<\/jats:p><\/jats:sec>","DOI":"10.1111\/trf.18275","type":"journal-article","created":{"date-parts":[[2025,5,5]],"date-time":"2025-05-05T13:50:21Z","timestamp":1746453021000},"page":"1273-1283","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Performance of a whole blood immunoassay for tenofovir detection and correlation with self\u2010reported pre\u2010exposure prophylaxis use in <scp>HIV<\/scp>\u2010negative men who have sex with men interested in blood donation"],"prefix":"10.1111","volume":"65","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3217-5898","authenticated-orcid":false,"given":"Renata","family":"Buccheri","sequence":"first","affiliation":[{"name":"Department of Epidemiology Vitalant Research Institute  San Francisco California USA"},{"name":"Department of Laboratory Medicine University of California San Francisco  San Francisco California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6311-6268","authenticated-orcid":false,"given":"Barbee","family":"Whitaker","sequence":"additional","affiliation":[{"name":"Center for Biologics Evaluation and Research U.S. Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lance M.","family":"Pollack","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine University of California San Francisco  San Francisco California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jahnavi Reddy","family":"Bhaskar","sequence":"additional","affiliation":[{"name":"Department of Epidemiology Vitalant Research Institute  San Francisco California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6047-211X","authenticated-orcid":false,"given":"Clara","family":"Di Germanio","sequence":"additional","affiliation":[{"name":"Department of Epidemiology Vitalant Research Institute  San Francisco California USA"},{"name":"Department of Laboratory Medicine University of California San Francisco  San Francisco California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Geraldine","family":"Guillon","sequence":"additional","affiliation":[{"name":"OraSure Technologies, Inc.  Bethlehem Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard","family":"Haaland","sequence":"additional","affiliation":[{"name":"HIV Laboratory Branch, Division of HIV Prevention U.S. Centers for Disease Control and Prevention  Atlanta Georgia USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susan L.","family":"Stramer","sequence":"additional","affiliation":[{"name":"American Red Cross Scientific Affairs  Gaithersburg Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rita","family":"Reik","sequence":"additional","affiliation":[{"name":"OneBlood  St. Petersburg Florida USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3614-2353","authenticated-orcid":false,"given":"Suchitra","family":"Pandey","sequence":"additional","affiliation":[{"name":"Stanford Blood Center Stanford University  Palo Alto California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mars","family":"Stone","sequence":"additional","affiliation":[{"name":"Department of Epidemiology Vitalant Research Institute  San Francisco California USA"},{"name":"Department of Laboratory Medicine University of California San Francisco  San Francisco California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Steven A.","family":"Anderson","sequence":"additional","affiliation":[{"name":"Center for Biologics Evaluation and Research U.S. Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Marks","sequence":"additional","affiliation":[{"name":"Center for Biologics Evaluation and Research U.S. Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6251-366X","authenticated-orcid":false,"given":"Brian","family":"Custer","sequence":"additional","affiliation":[{"name":"Department of Epidemiology Vitalant Research Institute  San Francisco California USA"},{"name":"Department of Laboratory Medicine University of California San Francisco  San Francisco California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,5,5]]},"reference":[{"key":"e_1_2_8_2_1","unstructured":"Center for Biologics Evaluation Research.Recommendations for evaluating donor eligibility using individual risk\u2010based questions to reduce the risk of human immunodeficiency virus transmission by blood and blood products [Internet]. 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