{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,17]],"date-time":"2026-06-17T14:42:17Z","timestamp":1781707337440,"version":"3.54.5"},"reference-count":18,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2011,8,2]],"date-time":"2011-08-02T00:00:00Z","timestamp":1312243200000},"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":[[2012,2]]},"abstract":"<jats:p><jats:bold>BACKGROUND:<\/jats:bold> Five cases of human immunodeficiency virus Type 1 (HIV\u20101) RNA\u2013positive blood donations are described that escaped detection by three different CE\u2010marked nucleic acid amplification technique (NAT) screening assays. These events were associated with two HIV\u20101 transmissions to recipients of blood components. The implicated NAT assays are monotarget assays and amplify in different viral genome regions (group\u2010specific antigen or long terminal repeat). Investigations into the cause of the false\u2010negative test results were initiated.<\/jats:p><jats:p><jats:bold>STUDY DESIGN AND METHODS:<\/jats:bold> Plasma specimens of the five NAT false\u2010negative cases were comparatively investigated in 12 CE\u2010marked HIV\u20101 NAT systems of differing design. The relative amplification efficiency for the HIV\u20101 variant was determined for each assay. Sequencing of the variants in the region targeted by each false\u2010negative NAT assay allowed comparison with the respective primers and probes.<\/jats:p><jats:p><jats:bold>RESULTS:<\/jats:bold> Some of the NAT assays designed in a similar way to false\u2010negative monotarget NATs also revealed deficiencies in detecting the viral variants. In each case sequencing of the assay target region in the variants demonstrated mismatches with primers and probes used by the assays. Some dual\u2010target assays showed decreased amplification efficiency, but not false\u2010negative results.<\/jats:p><jats:p><jats:bold>CONCLUSION:<\/jats:bold> HIV is characterized by its rapid evolution of new viral variants. The evolution of new sequences is unpredictable; NAT screening assays with a single target region appear to be more vulnerable to sequence variations than dual\u2010target assays. Based on this experience with false\u2010negative tests results by monotarget NAT assays, the Paul\u2010Ehrlich\u2010Institut is considering requesting dual\u2010target NAT assays for HIV\u20101 blood donation screening in Germany.<\/jats:p>","DOI":"10.1111\/j.1537-2995.2011.03281.x","type":"journal-article","created":{"date-parts":[[2011,8,2]],"date-time":"2011-08-02T20:23:56Z","timestamp":1312316636000},"page":"431-439","source":"Crossref","is-referenced-by-count":42,"title":["Blood screening nucleic acid amplification tests for human immunodeficiency virus Type 1 may require two different amplification targets"],"prefix":"10.1111","volume":"52","author":[{"given":"Michael","family":"Chudy","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marijke","family":"Weber\u2010Schehl","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lutz","family":"Pichl","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christine","family":"Jork","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julia","family":"Kress","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Margarethe","family":"Heiden","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Markus B.","family":"Funk","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"C. Micha","family":"N\u00fcbling","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2011,8,2]]},"reference":[{"key":"e_1_2_8_2_2","unstructured":"Joint United Nations Program on AIDS (UNAIDS).Report on the global AIDS epidemic. Chapter 2: Status of the global HIV epidemic.2008. [cited 01 Aug 2008]. Available from: URL:http:\/\/data.unaids.org\/pub\/GlobalReport\/2008\/jc1510_2008_global_report_pp29_62_en.pdf"},{"key":"e_1_2_8_3_2","doi-asserted-by":"publisher","DOI":"10.1007\/s00103-010-1152-6"},{"key":"e_1_2_8_4_2","unstructured":"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.Bundesanzeiger1998;53:12269\u201070."},{"key":"e_1_2_8_5_2","unstructured":"Verminderung des Risikos von HIV \u20101\u2014Infektionen durch zellul\u00e4re Blutprodukte und gefrorenes Frischplasma Anordnung der Testung auf HIV \u20101\u2010RNA mit Nukleins\u00e4ure\u2010Amplifikationstechniken.Bundesanzeiger2003;103:3835\u20106."},{"key":"e_1_2_8_6_2","doi-asserted-by":"publisher","DOI":"10.1006\/biol.1999.0223"},{"key":"e_1_2_8_7_2","unstructured":"Directive 98\/79\/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices. Official Journal of the European Communities1998; 7.12.98 L 331\/1\u201337. Available from: URL:http:\/\/eur\u2010lex.europa.eu\/LexUriServ\/site\/en\/oj\/1998\/l_331\/l_33119981207en00010037.pdf"},{"key":"e_1_2_8_8_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0166-0934(00)00283-4"},{"key":"e_1_2_8_9_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1537-2995.2009.02212.x"},{"key":"e_1_2_8_10_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1537-2995.2009.02203.x"},{"key":"e_1_2_8_11_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.00727-09"},{"key":"e_1_2_8_12_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.01832-09"},{"key":"e_1_2_8_13_2","doi-asserted-by":"publisher","DOI":"10.1373\/clinchem.2006.066498"},{"key":"e_1_2_8_14_2","doi-asserted-by":"publisher","DOI":"10.2353\/jmoldx.2010.090035"},{"key":"e_1_2_8_15_2","doi-asserted-by":"publisher","DOI":"10.1093\/nar\/25.3.654"},{"key":"e_1_2_8_16_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1537-2995.2010.02942.x"},{"key":"e_1_2_8_17_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1537-2995.2009.02477.x"},{"key":"e_1_2_8_18_2","first-page":"1335","article-title":"HIV transmission through transfusion\u2014Missouri and Colorado, 2008","volume":"59","author":"Laffoon B","year":"2010","journal-title":"MMWR"},{"key":"e_1_2_8_19_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1007644"}],"container-title":["Transfusion"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fj.1537-2995.2011.03281.x","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/j.1537-2995.2011.03281.x","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,10,14]],"date-time":"2023-10-14T12:28:09Z","timestamp":1697286489000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/j.1537-2995.2011.03281.x"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2011,8,2]]},"references-count":18,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2012,2]]}},"alternative-id":["10.1111\/j.1537-2995.2011.03281.x"],"URL":"https:\/\/doi.org\/10.1111\/j.1537-2995.2011.03281.x","archive":["Portico"],"relation":{},"ISSN":["0041-1132","1537-2995"],"issn-type":[{"value":"0041-1132","type":"print"},{"value":"1537-2995","type":"electronic"}],"subject":[],"published":{"date-parts":[[2011,8,2]]}}}