{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,2]],"date-time":"2026-09-02T11:18:57Z","timestamp":1788347937544,"version":"build-2803163510"},"reference-count":23,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2019,4,22]],"date-time":"2019-04-22T00:00:00Z","timestamp":1555891200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Vox Sanguinis"],"published-print":{"date-parts":[[2019,7]]},"abstract":"Background and Objectives<\/jats:title>In Germany, in addition to standard blood donor screening, further mandatory tests were introduced for HCV<\/jats:styled-content>\u2010RNA<\/jats:styled-content>, HIV<\/jats:styled-content>\u20101\u2010RNA<\/jats:styled-content> and for anti\u2010HB<\/jats:styled-content>c. Screening for HBV<\/jats:styled-content>\u2010DNA<\/jats:styled-content> is optional. This study investigates the benefits of these additional tests for the detection of HIV<\/jats:styled-content>, HCV<\/jats:styled-content>, and HBV<\/jats:styled-content> infections among German blood donors.<\/jats:p><\/jats:sec>Materials and Methods<\/jats:title>From 2008 to 2015 we collected data on blood donations exclusively testing NAT<\/jats:styled-content> positive (NAT<\/jats:styled-content> yield) or reactive in only one of the screening assays. Assuming a Poisson distribution, we calculated NAT<\/jats:styled-content> yield\/reactive only rates on a per donation basis (number of yield\/reactive only cases divided by the number of donations tested in the period under review) with 95% confidence intervals.<\/jats:p><\/jats:sec>Results<\/jats:title>Responding establishments covered 95% of the donations. We identified 20 HIV<\/jats:styled-content>\u20101\u2010NAT<\/jats:styled-content>, 61 HCV<\/jats:styled-content>\u2010NAT<\/jats:styled-content> and 29 HBV<\/jats:styled-content>\u2010NAT<\/jats:styled-content> yield cases among approximately 46 million blood donations tested corresponding to 0\u00b743 HIV<\/jats:styled-content>\u20101 NAT<\/jats:styled-content>, 1\u00b732 HCV<\/jats:styled-content>\u2010NAT<\/jats:styled-content>, and 0\u00b764 HBV<\/jats:styled-content>\u2010NAT<\/jats:styled-content> yield cases per million blood donations tested. For one HB<\/jats:styled-content>sAg reactive only case and 23 anti\u2010HB<\/jats:styled-content>c reactive only cases in repeat donors, infection was confirmed by ID<\/jats:styled-content>\u2010NAT<\/jats:styled-content> which translates into 0\u00b702 and 0\u00b755 cases per million donations tested. During the 8\u2010year\u2010observation period, one HIV<\/jats:styled-content>\u20101, no HCV<\/jats:styled-content> and four HBV<\/jats:styled-content> transmissions associated with donations in the viremic pre\u2010seroconversion window period were reported.<\/jats:p><\/jats:sec>Conclusion<\/jats:title>Annually, NAT screening alone detected 2\u00b75 HIV<\/jats:styled-content>\u20101, 7\u00b76 HCV<\/jats:styled-content>, and 3\u00b76 HBV<\/jats:styled-content> infectious donations; anti\u2010HBc screening alone identified 2\u00b79 infectious donations of repeat donors with occult HBV<\/jats:styled-content> infection. Overall, the survey results support that the currently practiced donor HIV\/HCV\/HBV screening strategy in Germany does ensure a high standard of blood safety.<\/jats:p><\/jats:sec>","DOI":"10.1111\/vox.12770","type":"journal-article","created":{"date-parts":[[2019,4,23]],"date-time":"2019-04-23T00:04:31Z","timestamp":1555977871000},"page":"443-450","source":"Crossref","is-referenced-by-count":31,"title":["Effectiveness of blood donor screening by HIV, HCV, HBV\u2010NAT assays, as well as HBsAg and anti\u2010HBc immunoassays in Germany (2008\u20132015)"],"prefix":"10.1111","volume":"114","author":[{"given":"Sarah A.","family":"Fiedler","sequence":"first","affiliation":[{"name":"Safety of Medicinal Products and Medical Devices Paul\u2010Ehrlich\u2010Institut Langen Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Doris","family":"Oberle","sequence":"additional","affiliation":[{"name":"Safety of Medicinal Products and Medical Devices Paul\u2010Ehrlich\u2010Institut Langen Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Chudy","sequence":"additional","affiliation":[{"name":"Testing Laboratory for in\u00a0vitro<\/i> diagnostic devices Section\u00a0of Molecular Virology Paul\u2010Ehrlich\u2010Institut Langen Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Heinrich","family":"Scheiblauer","sequence":"additional","affiliation":[{"name":"Testing Laboratory for in\u00a0vitro<\/i> diagnostic devices Section\u00a0of Molecular Virology Paul\u2010Ehrlich\u2010Institut Langen Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olaf","family":"Henseler","sequence":"additional","affiliation":[{"name":"Section\u00a0of Transfusion Medicine Paul\u2010Ehrlich\u2010Institut Langen Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jochen","family":"Halbauer","sequence":"additional","affiliation":[{"name":"Safety of Medicinal Products and Medical Devices Paul\u2010Ehrlich\u2010Institut Langen Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Margarethe","family":"Heiden","sequence":"additional","affiliation":[{"name":"Safety of Medicinal Products and Medical Devices Paul\u2010Ehrlich\u2010Institut Langen Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8642-1276","authenticated-orcid":false,"given":"Markus","family":"Funk","sequence":"additional","affiliation":[{"name":"Safety of Medicinal Products and Medical Devices Paul\u2010Ehrlich\u2010Institut Langen Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2019,4,22]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12985-016-0492-8"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/trf.13858"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1537-2995.2008.01966.x"},{"key":"e_1_2_8_5_1","unstructured":"Official Journal of the European Union:Directive 2002\/98\/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection testing processing storage and distribution of human blood and blood components and amending Directive 2001\/83\/EC.2003"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1423-0410.2007.01026.x"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1386-6532(06)80005-3"},{"key":"e_1_2_8_8_1","unstructured":"WHO Expert Committee on Biological Standardization:Guidelines on estimation of residual risk of HIV HBV or HCV infections via cellular blood components and plasma 2017"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1537-2995.2009.02212.x"},{"key":"e_1_2_8_10_1","unstructured":"German Drug Law:https:\/\/www.gesetze-im-internet.de\/amg_1976\/index.html. 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