{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,19]],"date-time":"2026-02-19T00:33:30Z","timestamp":1771461210318,"version":"3.50.1"},"reference-count":32,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2015,4,20]],"date-time":"2015-04-20T00:00:00Z","timestamp":1429488000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Vox Sanguinis"],"published-print":{"date-parts":[[2015,8]]},"abstract":"<jats:sec><jats:title>Background<\/jats:title><jats:p>Mandatory screening of blood donations for hepatitis B and hepatitis C viruses and human immunodeficiency viruses 1 and 2 requires assays with exceptional sensitivity and specificity. This study reports the results from a direct head\u2010to\u2010head comparison of the Elecsys <jats:styled-content style=\"fixed-case\">HB<\/jats:styled-content>s<jats:styled-content style=\"fixed-case\">AG II<\/jats:styled-content>, Elecsys Anti\u2010<jats:styled-content style=\"fixed-case\">HB<\/jats:styled-content>c, Elecsys Anti\u2010<jats:styled-content style=\"fixed-case\">HCV II<\/jats:styled-content> and Elecsys <jats:styled-content style=\"fixed-case\">HIV<\/jats:styled-content> combi <jats:styled-content style=\"fixed-case\">PT<\/jats:styled-content> immunoassays with the respective <jats:styled-content style=\"fixed-case\">ABBOTT PRISM<\/jats:styled-content>\/Architect instrument immunoassays in a multicentre blood bank evaluation study.<\/jats:p><\/jats:sec><jats:sec><jats:title>Study Design and Methods<\/jats:title><jats:p>Assay validation was performed in the blood screening laboratories of four blood bank centres in Austria, Germany, Spain and Thailand, where both first\u2010time donor samples (approximately 6000 donors) and repeat donor samples (approximately 14\u00a0000 donors) were screened.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Of all screened donor samples, 93 (0\u00b746%) were confirmed to be positive using assays from both manufacturers. The specificity of all immunoassays was &gt;99\u00b75% and was comparable between first\u2010time and multiple\u2010time donors. A direct comparison between the assays from Roche and <jats:styled-content style=\"fixed-case\">ABBOTT<\/jats:styled-content>\u00a0according to Bland and Altman analysis demonstrated equivalent quality.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>These results suggest that the Elecsys immunoassays for <jats:styled-content style=\"fixed-case\">HBV<\/jats:styled-content>,<jats:styled-content style=\"fixed-case\"> HCV<\/jats:styled-content> and <jats:styled-content style=\"fixed-case\">HIV<\/jats:styled-content> infection, with a comparative sensitivity of 100% and a specificity exceeding the common technical specification threshold of &gt;99\u00b75%, meet the stringent performance criteria stipulated for blood donor screening for these infectious agents. Significant differences in the specificity between first\u2010time and repeat donors were not detectable.<\/jats:p><\/jats:sec>","DOI":"10.1111\/vox.12259","type":"journal-article","created":{"date-parts":[[2015,4,20]],"date-time":"2015-04-20T16:23:25Z","timestamp":1429547005000},"page":"114-121","source":"Crossref","is-referenced-by-count":11,"title":["Head\u2010to\u2010head comparison between two screening systems for <scp>HB<\/scp>s<scp>AG<\/scp>, anti\u2010<scp>HB<\/scp>c, anti\u2010<scp>HCV<\/scp> and <scp>HIV<\/scp> combination immunoassays in an international, multicentre evaluation study"],"prefix":"10.1111","volume":"109","author":[{"given":"M.","family":"Schmidt","sequence":"first","affiliation":[{"name":"DRK\u2010Blutspendedienst Baden\u2010W\u00fcrttemberg, Hessen Institut f\u00fcr Transfusionsmedizin und Immunh\u00e4matologie Frankfurt 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