{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T06:00:35Z","timestamp":1790834435739,"version":"4.1.0"},"reference-count":37,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2017,12,17]],"date-time":"2017-12-17T00:00:00Z","timestamp":1513468800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2017,12,17]],"date-time":"2017-12-17T00:00:00Z","timestamp":1513468800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Transfusion"],"published-print":{"date-parts":[[2018,3]]},"abstract":"<jats:sec>\n                    <jats:title>BACKGROUND<\/jats:title>\n                    <jats:p>Use of nucleic acid testing (NAT) in donor infectious disease screening improves transfusion safety. Advances in NAT technology include improvements in assay sensitivity and system automation, and real\u2010time viral target discrimination in multiplex assays. This article describes the sensitivity and specificity of cobas MPX, a multiplex assay for detection of human immunodeficiency virus (HIV)\u20101 Group M, HIV\u20102 and HIV\u20101 Group O RNA, HCV RNA, and HBV DNA, for use on the cobas 6800\/8800 Systems.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>STUDY DESIGN AND METHODS<\/jats:title>\n                    <jats:p>The specificity of cobas MPX was evaluated in samples from donors of blood and source plasma in the United States. Analytic sensitivity was determined with reference standards. Infectious window periods (WPs) before NAT detectability were calculated for current donor screening assays.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS<\/jats:title>\n                    <jats:p>The specificity of cobas MPX was 99.946% (99.883%\u201099.980%) in 11,203 blood donor samples tested individually (IDT), 100% (99.994%\u2010100%) in 63,012 donor samples tested in pools of 6, and 99.994% (99.988%\u201099.998%) in 108,306 source plasma donations tested in pools of 96. Seven HCV NAT\u2010yield donations and one seronegative occult HBV infection were detected. Ninety\u2010five percent and 50% detection limits in plasma (IU\/mL) were 25.7 and 3.8 for HIV\u20101M, 7.0 and 1.3 for HCV, and 1.4 and 0.3 for HBV. The HBV WP was 1 to 4 days shorter than other donor screening assays by IDT.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>CONCLUSION<\/jats:title>\n                    <jats:p>cobas MPX demonstrated high specificity in blood and source plasma donations tested individually and in pools. High sensitivity, in particular for HBV, shortens the WP and may enhance detection of occult HBV.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/trf.14457","type":"journal-article","created":{"date-parts":[[2017,12,17]],"date-time":"2017-12-17T23:18:46Z","timestamp":1513552726000},"page":"649-659","source":"Crossref","is-referenced-by-count":37,"title":["Sensitivity and specificity of a new automated system for the detection of hepatitis B virus, hepatitis C virus, and human immunodeficiency virus nucleic acid in blood and plasma donations"],"prefix":"10.1111","volume":"58","author":[{"given":"Susan A.","family":"Galel","sequence":"first","affiliation":[{"name":"Roche Molecular Systems, Inc. Pleasanton California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Toby L.","family":"Simon","sequence":"additional","affiliation":[{"name":"CSL Plasma Laboratory Knoxville Tennessee"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Phillip C.","family":"Williamson","sequence":"additional","affiliation":[{"name":"Creative Testing Solutions Tempe Arizona"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7976-6871","authenticated-orcid":false,"given":"James P.","family":"AuBuchon","sequence":"additional","affiliation":[{"name":"Bloodworks Northwest"},{"name":"Departments of Medicine and Laboratory Medicine University of Washington Seattle Washington"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dan A.","family":"Waxman","sequence":"additional","affiliation":[{"name":"Indiana Blood Center Indianapolis Indiana"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yasuko","family":"Erickson","sequence":"additional","affiliation":[{"name":"Mississippi Valley Regional Blood Center Davenport Iowa"},{"name":"Department of Pathology University of Iowa Iowa City Iowa."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rasa","family":"Bertuzis","sequence":"additional","affiliation":[{"name":"Roche Molecular Systems, Inc. Pleasanton California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John R.","family":"Duncan","sequence":"additional","affiliation":[{"name":"Roche Molecular Systems, Inc. Pleasanton California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Khushbeer","family":"Malhotra","sequence":"additional","affiliation":[{"name":"Roche Molecular Systems, Inc. Pleasanton California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeffrey","family":"Vaks","sequence":"additional","affiliation":[{"name":"Roche Molecular Systems, Inc. Pleasanton California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nancy","family":"Huynh","sequence":"additional","affiliation":[{"name":"Roche Molecular Systems, Inc. Pleasanton California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lisa Lee","family":"Pate","sequence":"additional","affiliation":[{"name":"Roche Molecular Systems, Inc. Pleasanton California"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2017,12,17]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1423-0410.2011.01506.x"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1537-2995.2010.02622.x"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1537-2995.2004.04215.x"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1537-2995.2005.04390.x"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1537-2995.2003.00424.x"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1537-2995.2009.02322.x"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1111\/trf.12657"},{"key":"e_1_2_8_9_1","unstructured":"Procleix Ultrio Plus Assay Package Insert 502186EN Rev B (ex\u2010US)."},{"key":"e_1_2_8_10_1","unstructured":"Procleix Ultrio Elite Assay Package Insert 503049EN Rev A (ex\u2010US)."},{"key":"e_1_2_8_11_1","unstructured":"Roche Molecular Systems Inc. Internal documents. Pleasanton (CA): Roche Molecular Systems Inc."},{"key":"e_1_2_8_12_1","unstructured":"cobas\u00ae TaqScreen MPX Test. Version 2.0 for use on the cobas s 201 system 06327052001\u201005EN (CE\u2010IVD)."},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1537-2995.2010.02804.x"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1537-2995.2010.02732.x"},{"key":"e_1_2_8_15_1","unstructured":"Food and Drug Administration. Guidance for industry: nucleic acid testing (NAT) for human immunodeficiency virus type 1 (HIV\u20101) and hepatitis C virus (HCV): testing product disposition and donor deferral and reentry (May 2010) [Internet]. Rockville (MD): CBER Office of Communication Outreach and Development; 2010 [cited 2010 Dec 8]. Available from:http:\/\/www.fda.gov\/downloads\/BiologicsBloodVaccines\/GuidanceComplianceRegulatoryInformation\/Guidances\/Blood\/UCM210270.pdf."},{"key":"e_1_2_8_16_1","unstructured":"Food and Drug Administration. Guidance for industry: use of nucleic acid tests on pooled and individual samples from donors of whole blood and blood components including source plasma to reduce the risk of transmission of hepatitis B virus (October 2012) [Internet]. Rockville (MD): CBER Office of Communication Outreach and Development;2012. Available from:http:\/\/www.fda.gov\/BiologicsBloodVaccines\/GuidanceComplianceRegulatoryInformation\/Guidances\/Blood\/ucm327850.htm."},{"key":"e_1_2_8_17_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1423-0410.2012.01624.x"},{"key":"e_1_2_8_18_1","doi-asserted-by":"publisher","DOI":"10.1111\/trf.12213"},{"key":"e_1_2_8_19_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa040085"},{"key":"e_1_2_8_20_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1537-2995.2002.00236.x"},{"key":"e_1_2_8_21_1","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.01229-07"},{"key":"e_1_2_8_22_1","doi-asserted-by":"publisher","DOI":"10.1111\/trf.13759"},{"key":"e_1_2_8_23_1","doi-asserted-by":"publisher","DOI":"10.1111\/trf.13819"},{"key":"e_1_2_8_24_1","doi-asserted-by":"publisher","DOI":"10.1111\/trf.12902"},{"key":"e_1_2_8_25_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1537-2995.2008.02041.x"},{"key":"e_1_2_8_26_1","doi-asserted-by":"publisher","DOI":"10.1111\/trf.12299"},{"key":"e_1_2_8_27_1","doi-asserted-by":"publisher","DOI":"10.1111\/trf.13024"},{"key":"e_1_2_8_28_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1537-2995.2010.03023.x"},{"key":"e_1_2_8_29_1","doi-asserted-by":"publisher","DOI":"10.1111\/trf.12694"},{"key":"e_1_2_8_30_1","doi-asserted-by":"publisher","DOI":"10.1111\/vox.12075"},{"key":"e_1_2_8_31_1","doi-asserted-by":"publisher","DOI":"10.1111\/trf.12178"},{"key":"e_1_2_8_32_1","doi-asserted-by":"publisher","DOI":"10.1111\/trf.12962"},{"key":"e_1_2_8_33_1","first-page":"147","article-title":"HIV\u20101 Group O origin, evolution, pathogenesis, and treatment: unraveling the complexity of an outlier 25 years later","volume":"17","author":"Bush S","year":"2015","journal-title":"AIDS Rev"},{"key":"e_1_2_8_34_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.meegid.2016.08.010"},{"key":"e_1_2_8_35_1","doi-asserted-by":"publisher","DOI":"10.1097\/00042560-199806010-00014"},{"key":"e_1_2_8_36_1","doi-asserted-by":"publisher","DOI":"10.1111\/trf.13600"},{"key":"e_1_2_8_37_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00430-012-0250-5"},{"key":"e_1_2_8_38_1","doi-asserted-by":"publisher","DOI":"10.1080\/14737159.2017.1275962"}],"container-title":["Transfusion"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Ftrf.14457","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/trf.14457","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/trf.14457","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/trf.14457","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,3,8]],"date-time":"2026-03-08T11:28:56Z","timestamp":1772969336000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/trf.14457"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2017,12,17]]},"references-count":37,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2018,3]]}},"alternative-id":["10.1111\/trf.14457"],"URL":"https:\/\/doi.org\/10.1111\/trf.14457","archive":["Portico"],"relation":{},"ISSN":["0041-1132","1537-2995"],"issn-type":[{"value":"0041-1132","type":"print"},{"value":"1537-2995","type":"electronic"}],"subject":[],"published":{"date-parts":[[2017,12,17]]}}}