{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,13]],"date-time":"2026-01-13T15:40:48Z","timestamp":1768318848003,"version":"3.49.0"},"reference-count":37,"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":"Background<\/jats:title>This study assessed the clinical sensitivity of three fully automated, human immunodeficiency virus (HIV<\/jats:styled-content>), hepatitis\u2009C virus (HCV<\/jats:styled-content>), and hepatitis\u2009B virus (HBV<\/jats:styled-content>) triplex nucleic acid test (NAT<\/jats:styled-content>) assays by individual donation (ID<\/jats:styled-content>\u2010NAT<\/jats:styled-content>) and at operational minipool (MP<\/jats:styled-content>\u2010NAT<\/jats:styled-content>) sizes used worldwide.<\/jats:p><\/jats:sec>Study Design and Methods<\/jats:title>MPX<\/jats:styled-content>, U<\/jats:styled-content>ltrio, and U<\/jats:styled-content>ltrio P<\/jats:styled-content>lus were used to test 2222 pedigreed, marker\u2010positive samples with varying viral loads, each from a unique US<\/jats:styled-content> blood donor. NAT<\/jats:styled-content>\u2010positive, seronegative yield samples (16 HBV<\/jats:styled-content>, 156 HCV<\/jats:styled-content>, and 23 HIV<\/jats:styled-content>) were tested in replicates of three; undiluted; and in 1:6, 1:8, and 1:16 dilutions (MP<\/jats:styled-content>6, MP<\/jats:styled-content>8, and MP<\/jats:styled-content>16), simulating various MP<\/jats:styled-content> sizes. Seropositive samples (1276 HBV<\/jats:styled-content>, 488 HCV<\/jats:styled-content>, and 263 HIV<\/jats:styled-content>) were tested by ID<\/jats:styled-content>\u2010NAT<\/jats:styled-content> in singlet.<\/jats:p><\/jats:sec>Results<\/jats:title>MPX<\/jats:styled-content>\u2010MP<\/jats:styled-content>6 and U<\/jats:styled-content>ltrio P<\/jats:styled-content>lus\u2010MP<\/jats:styled-content>16 had equivalent HCV<\/jats:styled-content> sensitivity. Although U<\/jats:styled-content>ltrio P<\/jats:styled-content>lus\u2010MP<\/jats:styled-content>16 for HIV<\/jats:styled-content> trended toward lesser sensitivity, this was not corroborated in a large substudy of low\u2010viral\u2010load samples in which U<\/jats:styled-content>ltrio P<\/jats:styled-content>lus\u2010MP<\/jats:styled-content>8\/MP<\/jats:styled-content>16 showed 100% reactivity. MPX<\/jats:styled-content>\u2010ID<\/jats:styled-content> and U<\/jats:styled-content>ltrio P<\/jats:styled-content>lus\u2010ID HBV<\/jats:styled-content> clinical sensitivity were identical, but MPX<\/jats:styled-content>\u2010MP<\/jats:styled-content>6 was significantly more sensitive than U<\/jats:styled-content>ltrio P<\/jats:styled-content>lus\u2010MP<\/jats:styled-content>16; the differential yield projected to one HBV NAT<\/jats:styled-content> yield per 4.72 million US<\/jats:styled-content> donations. U<\/jats:styled-content>ltrio P<\/jats:styled-content>lus HBV<\/jats:styled-content> sensitivity did not increase at MP<\/jats:styled-content>8 versus MP<\/jats:styled-content>16. U<\/jats:styled-content>ltrio P<\/jats:styled-content>lus versus U<\/jats:styled-content>ltrio sensitivity was significantly increased in HBV<\/jats:styled-content>\u2010infected donors with early acute, late acute or chronic, and occult infections. No difference in sensitivity was noted for any virus for MPX<\/jats:styled-content>\u2010MP<\/jats:styled-content>6 versus U<\/jats:styled-content>ltrio P<\/jats:styled-content>lus\u2010ID<\/jats:styled-content>.<\/jats:p><\/jats:sec>Conclusions<\/jats:title>Our data support US<\/jats:styled-content> donation screening with MPX<\/jats:styled-content>\u2010MP<\/jats:styled-content>6 or U<\/jats:styled-content>ltrio P<\/jats:styled-content>lus\u2010MP<\/jats:styled-content>16 since the HBV DNA<\/jats:styled-content> detection of U<\/jats:styled-content>ltrio P<\/jats:styled-content>lus was significantly enhanced (vs. U<\/jats:styled-content>ltrio) without compromising HIV<\/jats:styled-content> or HCV RNA<\/jats:styled-content> detection.<\/jats:p><\/jats:sec>","DOI":"10.1111\/trf.12178","type":"journal-article","created":{"date-parts":[[2013,4,3]],"date-time":"2013-04-03T10:21:40Z","timestamp":1364984500000},"page":"2525-2537","source":"Crossref","is-referenced-by-count":54,"title":["Comparative analysis of triplex nucleic acid test assays in United States blood donors"],"prefix":"10.1111","volume":"53","author":[{"given":"Susan L.","family":"Stramer","sequence":"first","affiliation":[{"name":"Scientific Support Office American Red Cross Gaithersburg Maryland"},{"name":"Quality Analytics Riverwoods Illinois"},{"name":"Creative Testing Solutions Tampa Florida"},{"name":"Holland Laboratory American Red Cross Rockville Maryland"},{"name":"University of British Columbia Victoria British Columbia Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David E.","family":"Krysztof","sequence":"additional","affiliation":[{"name":"Scientific Support Office American Red Cross Gaithersburg Maryland"},{"name":"Quality Analytics Riverwoods Illinois"},{"name":"Creative Testing Solutions Tampa Florida"},{"name":"Holland Laboratory American Red Cross Rockville Maryland"},{"name":"University of British Columbia Victoria British Columbia Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jaye P.","family":"Brodsky","sequence":"additional","affiliation":[{"name":"Scientific Support Office American Red Cross Gaithersburg Maryland"},{"name":"Quality Analytics Riverwoods Illinois"},{"name":"Creative Testing Solutions Tampa Florida"},{"name":"Holland Laboratory American Red Cross Rockville Maryland"},{"name":"University of British Columbia Victoria British Columbia Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tracy A.","family":"Fickett","sequence":"additional","affiliation":[{"name":"Scientific Support Office American Red Cross Gaithersburg Maryland"},{"name":"Quality Analytics Riverwoods Illinois"},{"name":"Creative Testing Solutions Tampa Florida"},{"name":"Holland Laboratory American Red Cross Rockville Maryland"},{"name":"University of British Columbia Victoria British Columbia Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Benjamin","family":"Reynolds","sequence":"additional","affiliation":[{"name":"Scientific Support Office American Red Cross Gaithersburg Maryland"},{"name":"Quality Analytics Riverwoods Illinois"},{"name":"Creative Testing Solutions Tampa Florida"},{"name":"Holland Laboratory American Red Cross Rockville Maryland"},{"name":"University of British Columbia Victoria British Columbia Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Roger Y.","family":"Dodd","sequence":"additional","affiliation":[{"name":"Scientific Support Office American Red Cross Gaithersburg Maryland"},{"name":"Quality Analytics Riverwoods Illinois"},{"name":"Creative Testing Solutions Tampa Florida"},{"name":"Holland Laboratory American Red Cross Rockville Maryland"},{"name":"University of British Columbia Victoria British Columbia Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Steven H.","family":"Kleinman","sequence":"additional","affiliation":[{"name":"Scientific Support Office American Red Cross Gaithersburg Maryland"},{"name":"Quality Analytics Riverwoods Illinois"},{"name":"Creative Testing Solutions Tampa Florida"},{"name":"Holland Laboratory American Red Cross Rockville Maryland"},{"name":"University of British Columbia Victoria British Columbia Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2013,10,17]]},"reference":[{"key":"e_1_2_8_2_1","unstructured":"Roche Molecular Systems Inc.cobas\u00ae TaqScreen MPX Test for use on the cobas s 201 System product insert: 1636 Rev4.2009. 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