{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,23]],"date-time":"2026-02-23T22:09:20Z","timestamp":1771884560576,"version":"3.50.1"},"reference-count":31,"publisher":"Wiley","issue":"10pt2","license":[{"start":{"date-parts":[[2013,10,17]],"date-time":"2013-10-17T00:00:00Z","timestamp":1381968000000},"content-version":"vor","delay-in-days":16,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Transfusion"],"published-print":{"date-parts":[[2013,10]]},"abstract":"<jats:sec><jats:title>Background<\/jats:title><jats:p>Nucleic acid amplification techniques (<jats:styled-content style=\"fixed-case\">NAT<\/jats:styled-content>) in routine blood donor screening considerably reduce the diagnostic window phase period. Nevertheless, several reports of false\u2010negative <jats:styled-content style=\"fixed-case\">NAT<\/jats:styled-content> results were published. Here, four cases of human immunodeficiency virus Type 1 (<jats:styled-content style=\"fixed-case\">HIV<\/jats:styled-content>\u20101) <jats:styled-content style=\"fixed-case\">RNA<\/jats:styled-content>\u2013positive blood donations that escaped detection by <jats:styled-content style=\"fixed-case\">NAT<\/jats:styled-content> screening are described.<\/jats:p><\/jats:sec><jats:sec><jats:title>Study Design and Methods<\/jats:title><jats:p>A total of 2.7 million blood donations were screened for viral infections between <jats:styled-content style=\"fixed-case\">J<\/jats:styled-content>anuary 2010 and <jats:styled-content style=\"fixed-case\">O<\/jats:styled-content>ctober 2012 in our <jats:styled-content style=\"fixed-case\">G<\/jats:styled-content>erman <jats:styled-content style=\"fixed-case\">R<\/jats:styled-content>ed <jats:styled-content style=\"fixed-case\">C<\/jats:styled-content>ross blood donation service. Four plasma specimens with false\u2010negative <jats:styled-content style=\"fixed-case\">NAT<\/jats:styled-content> results were comparatively investigated with 12 <jats:styled-content style=\"fixed-case\">CE<\/jats:styled-content>\u2010marked <jats:styled-content style=\"fixed-case\">NAT<\/jats:styled-content> assays. In two cases of putative <jats:styled-content style=\"fixed-case\">HIV<\/jats:styled-content>\u20101 variants the target region of the <jats:styled-content style=\"fixed-case\">NAT<\/jats:styled-content> assay was sequenced allowing comparison with the respective primers and probes.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Most of the <jats:styled-content style=\"fixed-case\">NAT<\/jats:styled-content> assays used in routine blood donor screening with the 5\u2032\u2010long terminal repeat (<jats:styled-content style=\"fixed-case\">LTR<\/jats:styled-content>) as target region demonstrated deficiencies in detecting the viral variants and the low\u2010viral\u2010carrier donations. Sequence analysis revealed in one case a deletion of 56 nucleotides within the 5\u2032\u2010<jats:styled-content style=\"fixed-case\">LTR<\/jats:styled-content> preventing the binding of the probe accompanied by a neighbored insertion of another 52 nucleotides and several primer mismatches in another case. No false\u2010negative results were obtained for these cases using dual\u2010target assays. The viral load of the remaining two false\u2010negative results was below the <jats:styled-content style=\"fixed-case\">NAT<\/jats:styled-content>'s limit of detection.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p><jats:styled-content style=\"fixed-case\">HIV<\/jats:styled-content>\u20101 is characterized by a high mutation rate and rapid generation of new viral variants. By the use of one target region for <jats:styled-content style=\"fixed-case\">HIV<\/jats:styled-content>\u20101 <jats:styled-content style=\"fixed-case\">NAT<\/jats:styled-content> assays there is a certain risk of false\u2010negative results. Employing <jats:styled-content style=\"fixed-case\">HIV<\/jats:styled-content>\u20101 multi\u2010 and dual\u2010target assays in routine blood donor screening seems to be a reasonable possibility to minimize this problem.<\/jats:p><\/jats:sec>","DOI":"10.1111\/trf.12298","type":"journal-article","created":{"date-parts":[[2013,6,20]],"date-time":"2013-06-20T03:25:53Z","timestamp":1371698753000},"page":"2422-2430","source":"Crossref","is-referenced-by-count":31,"title":["How safe is safe: new human immunodeficiency virus Type 1 variants missed by nucleic acid testing"],"prefix":"10.1111","volume":"53","author":[{"given":"Benjamin","family":"M\u00fcller","sequence":"first","affiliation":[{"name":"DRK Blutspendedienst West  Hagen Germany"},{"name":"Paul\u2010Ehrlich\u2010Institut  Langen Germany"},{"name":"GFE Blut mbH  Frankfurt am Main Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"C. Micha","family":"N\u00fcbling","sequence":"additional","affiliation":[{"name":"DRK Blutspendedienst West  Hagen Germany"},{"name":"Paul\u2010Ehrlich\u2010Institut  Langen Germany"},{"name":"GFE Blut mbH  Frankfurt am Main Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Julia","family":"Kress","sequence":"additional","affiliation":[{"name":"DRK Blutspendedienst West  Hagen Germany"},{"name":"Paul\u2010Ehrlich\u2010Institut  Langen Germany"},{"name":"GFE Blut mbH  Frankfurt am Main Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"W. Kurt","family":"Roth","sequence":"additional","affiliation":[{"name":"DRK Blutspendedienst West  Hagen Germany"},{"name":"Paul\u2010Ehrlich\u2010Institut  Langen Germany"},{"name":"GFE Blut mbH  Frankfurt am Main Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Silke","family":"De Zolt","sequence":"additional","affiliation":[{"name":"DRK Blutspendedienst West  Hagen Germany"},{"name":"Paul\u2010Ehrlich\u2010Institut  Langen Germany"},{"name":"GFE Blut mbH  Frankfurt am Main Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lutz","family":"Pichl","sequence":"additional","affiliation":[{"name":"DRK Blutspendedienst West  Hagen Germany"},{"name":"Paul\u2010Ehrlich\u2010Institut  Langen Germany"},{"name":"GFE Blut mbH  Frankfurt am Main Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2013,10,17]]},"reference":[{"key":"e_1_2_8_2_1","first-page":"256","article-title":"HIV\u2010infektionen und AIDS\u2010erkrankungen in Deutschland","volume":"28","author":"Seedat J","year":"2012","journal-title":"Epidemiol Bull"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00103-012-1516-1"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1172\/JCI34706"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1537-2995.2011.03281.x"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1423-0410.2011.01506.x"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1537-2995.2002.00129.x"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1537-2995.2002.00128.x"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(98)06318-1"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1537-2995.2009.02203.x"},{"key":"e_1_2_8_11_1","first-page":"12269","article-title":"Bekanntmachung \u00fcber die Ergebnisse des Stufenplanverfahrens zur Verminderung des Risikos von Hepatitis B\u2010, Hepatitis C\u2010 und HIV\u2010Infektionen bei Empf\u00e4ngern von Erythrozytenkonzentraten (BAnz. Nr. 63 vom 04.04.97, S. 4477) vom 25. Februar 1998","volume":"53","author":"Paul\u2010Ehrlich\u2010Institut","year":"1998","journal-title":"Bundesanzeiger"},{"key":"e_1_2_8_12_1","first-page":"3835","article-title":"Verminderung des Risikos von HIV\u2010I\u2010Infektionen durch zellul\u00e4re Blutprodukte und gefrorenes Frischplasma. Anordnung der Testung auf HIV\u2010I\u2010RNA mit Nukleins\u00e4ure\u2010Amplifikationstechniken","volume":"103","author":"Paul\u2010Ehrlich\u2010Institut","year":"2003","journal-title":"Bundesanzeiger"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1537-2995.2008.01718.x"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.1128\/JVI.02660-07"},{"key":"e_1_2_8_15_1","article-title":"Anordnung von Ma\u00dfnahmen zur Risikominimierung beim Einsatz von HIV\u20101 NAT\u2010Testsystemen (BAnz AT 12.09.2012 B6)","author":"Paul\u2010Ehrlich\u2010Institut","year":"2012","journal-title":"Bundesanzeiger"},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.seminhematol.2006.09.016"},{"key":"e_1_2_8_17_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2516.2006.01194.x"},{"key":"e_1_2_8_18_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1537-2995.2006.00964.x"},{"key":"e_1_2_8_19_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jviromet.2005.10.013"},{"key":"e_1_2_8_20_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jviromet.2004.08.018"},{"key":"e_1_2_8_21_1","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.42.1.21-29.2004"},{"key":"e_1_2_8_22_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1537-2995.2008.01966.x"},{"key":"e_1_2_8_23_1","first-page":"87","article-title":"Evolving approaches to estimate risks of transfusion\u2010transmitted viral infections: incidence\u2010window period model after ten years","volume":"127","author":"Busch MR","year":"2007","journal-title":"Dev Biol (Basel)"},{"key":"e_1_2_8_24_1","doi-asserted-by":"publisher","DOI":"10.1097\/00002030-200309050-00005"},{"issue":"1","key":"e_1_2_8_25_1","first-page":"55","article-title":"Observed yield and projected residual risk using HIV individual donation (ID)\u2010NAT, minipool (MP)\u2010NAT or HIV p24 antigen (p24 Ag) screening in South Africa","volume":"95","author":"Vermeulen M","year":"2008","journal-title":"Vox Sang"},{"key":"e_1_2_8_26_1","doi-asserted-by":"publisher","DOI":"10.1093\/nar\/25.3.654"},{"key":"e_1_2_8_27_1","doi-asserted-by":"publisher","DOI":"10.2353\/jmoldx.2010.090035"},{"key":"e_1_2_8_28_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-2362.1999.00462.x"},{"key":"e_1_2_8_29_1","doi-asserted-by":"publisher","DOI":"10.1373\/clinchem.2006.066498"},{"key":"e_1_2_8_30_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1537-2995.2009.02322.x"},{"key":"e_1_2_8_31_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jviromet.2006.11.026"},{"key":"e_1_2_8_32_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jviromet.2006.01.012"}],"container-title":["Transfusion"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Ftrf.12298","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/trf.12298","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,13]],"date-time":"2023-09-13T11:28:27Z","timestamp":1694604507000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/trf.12298"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2013,10]]},"references-count":31,"journal-issue":{"issue":"10pt2","published-print":{"date-parts":[[2013,10]]}},"alternative-id":["10.1111\/trf.12298"],"URL":"https:\/\/doi.org\/10.1111\/trf.12298","archive":["Portico"],"relation":{},"ISSN":["0041-1132","1537-2995"],"issn-type":[{"value":"0041-1132","type":"print"},{"value":"1537-2995","type":"electronic"}],"subject":[],"published":{"date-parts":[[2013,10]]}}}