{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,22]],"date-time":"2025-10-22T17:56:28Z","timestamp":1761155788765},"reference-count":25,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2014,4,17]],"date-time":"2014-04-17T00:00:00Z","timestamp":1397692800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Transfusion"],"published-print":{"date-parts":[[2014,10]]},"abstract":"<jats:sec><jats:title>Background<\/jats:title><jats:p>Sensitive triplex nucleic acid tests (NATs) are implemented for blood donation screening worldwide. Assays have variable ability to detect low\u2010level hepatitis B virus (<jats:styled-content style=\"fixed-case\">HBV<\/jats:styled-content>) <jats:styled-content style=\"fixed-case\">DNA<\/jats:styled-content>. At borderline <jats:styled-content style=\"fixed-case\">DNA<\/jats:styled-content> detection levels, where <jats:styled-content style=\"fixed-case\">P<\/jats:styled-content>oisson distribution impacts results, distinguishing true\u2010positive from false\u2010positive results is challenging. Algorithms are needed to confirm such low\u2010level <jats:styled-content style=\"fixed-case\">HBV DNA<\/jats:styled-content>\u2013positive samples.<\/jats:p><\/jats:sec><jats:sec><jats:title>Study Design and Methods<\/jats:title><jats:p>A total of 135 blood donor samples reactive by one or more <jats:styled-content style=\"fixed-case\">HBV<\/jats:styled-content> markers that provided discrepant results were tested undiluted with four commercial <jats:styled-content style=\"fixed-case\">NAT<\/jats:styled-content>s: <jats:styled-content style=\"fixed-case\">U<\/jats:styled-content>ltrio, <jats:styled-content style=\"fixed-case\">U<\/jats:styled-content>ltrio <jats:styled-content style=\"fixed-case\">P<\/jats:styled-content>lus, <jats:styled-content style=\"fixed-case\">MPX<\/jats:styled-content>, and a quantitative assay (<jats:styled-content style=\"fixed-case\">S<\/jats:styled-content>uper<jats:styled-content style=\"fixed-case\">Q<\/jats:styled-content>uant). To further explore discrepancies, three additional in\u2010house <jats:styled-content style=\"fixed-case\">NAT<\/jats:styled-content>s including real\u2010time polymerase chain reaction (<jats:styled-content style=\"fixed-case\">PCR<\/jats:styled-content>) and nested <jats:styled-content style=\"fixed-case\">PCR<\/jats:styled-content> and sequencing were performed.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The numbers reactive of these 135 \u201cdifficult\u201d samples by four commercial <jats:styled-content style=\"fixed-case\">NAT<\/jats:styled-content>s were as follows: 39 of 107 (36%) with <jats:styled-content style=\"fixed-case\">S<\/jats:styled-content>uper<jats:styled-content style=\"fixed-case\">Q<\/jats:styled-content>uant, 40 (30%) with <jats:styled-content style=\"fixed-case\">U<\/jats:styled-content>ltrio, 100 (74%) with <jats:styled-content style=\"fixed-case\">U<\/jats:styled-content>ltrio <jats:styled-content style=\"fixed-case\">P<\/jats:styled-content>lus, and 102 (76%) with <jats:styled-content style=\"fixed-case\">MPX<\/jats:styled-content>. Of the seven <jats:styled-content style=\"fixed-case\">NAT<\/jats:styled-content>s, 109 (81%) samples were reactive by at least two assays and thus considered confirmed positive of which 67 (50%) generated a sequence. <jats:styled-content style=\"fixed-case\">U<\/jats:styled-content>ltrio <jats:styled-content style=\"fixed-case\">P<\/jats:styled-content>lus and <jats:styled-content style=\"fixed-case\">MPX<\/jats:styled-content> performed similarly as above (80%\u201085% detected of 109 and 81%\u201090% of 67, respectively). Older (median, 49 years), <jats:styled-content style=\"fixed-case\">HBV<\/jats:styled-content> core antibody\u2013reactive donors carried predominantly <jats:styled-content style=\"fixed-case\">G<\/jats:styled-content>enotype <jats:styled-content style=\"fixed-case\">A<\/jats:styled-content> (58%) with high\u2010frequency amino acid substitutions in the major hydrophilic region of the <jats:styled-content style=\"fixed-case\">S<\/jats:styled-content>\u2010protein. Younger (median, 24 years) hepatitis <jats:styled-content style=\"fixed-case\">B<\/jats:styled-content> surface antigen\u2013positive donors carried wild\u2010type strains predominantly <jats:styled-content style=\"fixed-case\">G<\/jats:styled-content>enotype <jats:styled-content style=\"fixed-case\">B<\/jats:styled-content> (32%) and <jats:styled-content style=\"fixed-case\">E<\/jats:styled-content> (24%), the latter in an apparent cluster.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Highly sensitive <jats:styled-content style=\"fixed-case\">NAT<\/jats:styled-content>s require new confirmatory algorithms as presented optimally using different genomic regions or sequence generation. The introduction of immigration\u2010related <jats:styled-content style=\"fixed-case\">HBV<\/jats:styled-content> genotypes may impact <jats:styled-content style=\"fixed-case\">HBV<\/jats:styled-content> epidemiology in the <jats:styled-content style=\"fixed-case\">U<\/jats:styled-content>nited <jats:styled-content style=\"fixed-case\">S<\/jats:styled-content>tates.<\/jats:p><\/jats:sec>","DOI":"10.1111\/trf.12653","type":"journal-article","created":{"date-parts":[[2014,4,17]],"date-time":"2014-04-17T08:22:59Z","timestamp":1397722979000},"page":"2485-2495","source":"Crossref","is-referenced-by-count":25,"title":["Comparison of seven hepatitis <scp>B<\/scp> virus (<scp>HBV<\/scp>) nucleic acid testing assays in selected samples with discrepant <scp>HBV<\/scp> marker results from <scp>U<\/scp>nited <scp>S<\/scp>tates blood donors"],"prefix":"10.1111","volume":"54","author":[{"given":"Florence","family":"Enjalbert","sequence":"first","affiliation":[{"name":"Department of Haematology University of Cambridge  Cambridge United Kingdom"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David E.","family":"Krysztof","sequence":"additional","affiliation":[{"name":"Scientific Support Office American Red Cross  Gaithersburg Maryland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Daniel","family":"Candotti","sequence":"additional","affiliation":[{"name":"National Health Service Blood and Transplant  Cambridge United Kingdom"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jean\u2010Pierre","family":"Allain","sequence":"additional","affiliation":[{"name":"Department of Haematology University of Cambridge  Cambridge United Kingdom"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Susan L.","family":"Stramer","sequence":"additional","affiliation":[{"name":"Scientific Support Office American Red Cross  Gaithersburg Maryland"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2014,4,17]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1423-0410.2011.01506.x"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1537-2995.2005.00198.x"},{"key":"e_1_2_7_4_1","unstructured":"US Food and Drug Administration.Guidance for industry use of nucleic acid tests on pooled and individual samples from donors of whole blood and blood components including source plasma to reduce the risk of transmission of hepatitis B virus. October2012[cited 2014 Mar 21]. Available from:http:\/\/www.fda.gov\/BiologicsBloodVaccines\/GuidanceComplianceRegulatoryInformation\/Guidances\/Blood\/ucm327850.htm"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.0042-9007.2004.00406.x"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1007644"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1537-2995.2010.02804.x"},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.1111\/trf.12178"},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2002-04-1084"},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.1099\/vir.0.83102-0"},{"key":"e_1_2_7_11_1","doi-asserted-by":"publisher","DOI":"10.1099\/vir.0.83347-0"},{"key":"e_1_2_7_12_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1537-2995.2011.03281.x"},{"key":"e_1_2_7_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0166-0934(00)00177-4"},{"key":"e_1_2_7_14_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1537-2995.2007.01343.x"},{"key":"e_1_2_7_15_1","doi-asserted-by":"publisher","DOI":"10.1111\/trf.12165"},{"key":"e_1_2_7_16_1","unstructured":"Gen\u2010Probe Incorporated.Procleix\u00ae Ultrio\u00ae Assay product insert: 502165 Rev. A.2011. San Diego CA USA."},{"key":"e_1_2_7_17_1","unstructured":"Gen\u2010Probe Incorporated.Procleix\u00ae Ultrio\u00ae Plus Assay product insert: 502932 Rev. 7.2012. San Diego CA USA."},{"key":"e_1_2_7_18_1","doi-asserted-by":"publisher","DOI":"10.1111\/trf.12213"},{"key":"e_1_2_7_19_1","first-page":"174","article-title":"Diagnostic algorithm for HBV safe transfusion","volume":"7","author":"Allain JP","year":"2009","journal-title":"Blood Transfus"},{"key":"e_1_2_7_20_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhep.2008.04.017"},{"key":"e_1_2_7_21_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.22879"},{"key":"e_1_2_7_22_1","doi-asserted-by":"publisher","DOI":"10.1136\/gutjnl-2011-301281"},{"key":"e_1_2_7_23_1","doi-asserted-by":"publisher","DOI":"10.1093\/infdis\/jir862"},{"key":"e_1_2_7_24_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1537-2995.2008.01813.x"},{"key":"e_1_2_7_25_1","doi-asserted-by":"publisher","DOI":"10.1053\/gast.2002.33588"},{"key":"e_1_2_7_26_1","doi-asserted-by":"publisher","DOI":"10.1093\/oxfordjournals.aje.a009474"}],"container-title":["Transfusion"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Ftrf.12653","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/trf.12653","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,29]],"date-time":"2023-09-29T13:28:47Z","timestamp":1695994127000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/trf.12653"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2014,4,17]]},"references-count":25,"journal-issue":{"issue":"10","published-print":{"date-parts":[[2014,10]]}},"alternative-id":["10.1111\/trf.12653"],"URL":"https:\/\/doi.org\/10.1111\/trf.12653","archive":["Portico"],"relation":{},"ISSN":["0041-1132","1537-2995"],"issn-type":[{"value":"0041-1132","type":"print"},{"value":"1537-2995","type":"electronic"}],"subject":[],"published":{"date-parts":[[2014,4,17]]}}}