{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,13]],"date-time":"2025-11-13T12:35:22Z","timestamp":1763037322952,"version":"3.41.2"},"reference-count":15,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2019,5,6]],"date-time":"2019-05-06T00:00:00Z","timestamp":1557100800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Laboratory Analysis"],"published-print":{"date-parts":[[2019,7]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>The seroprevalence rate of human T\u2010lymphotropic virus I and II (HTLV\u2010I\/II) in Korean blood donors has been known as 0.004%, and HTLV\u2010I\/II Ab screening test has been performed since 2008 in Korea. Korea Ministry of Food and Drug Safety (MFDS) approved two chemiluminescent microparticle immunoassays (CMIA) for testing HTLV\u2010I\/II antibody, ABBOTT PRISM HTLV\u2010I\/HTLV\u2010II and ARCHITECT rHTLV\u2010I\/II. A multicenter performance evaluation\u00a0study in Europe and Japan was carried out with\u00a0the new electrochemiluminescence immunoassay (ECLIA)\u00a0for HTLV\u2010I\/II antibody detection, Elecsys HTLV\u2010I\/II assay\u00a0which launched in 2017, but not in Korea. We aimed to evaluate the clinical performance of Elecsys HTLV\u2010I\/II assay in comparison with ARCHITECT rHTLV\u2010I\/II for the detection of HTLV\u2010I\/II\u00a0antibody with Korean samples.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>For sensitivity evaluation, 100 HTLV\u2010I\/II\u2010positive Korean standards from Korean Red Cross and two HTLV\u2010II\u2010positive samples that were\u00a0purchased from Seracure were used. For the specificity, 500 potential donor specimens from Korea University Hospital healthcare center were used. All the samples were simultaneously analyzed by the two HTLV\u2010I\/II assays, Elecsys HTLV\u2010I\/II assay and ARCHITECT rHTLV\u2010I\/II assay.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Elecsys HTLV\u2010I\/II assay and ARCHITECT rHTLV\u2010I\/II assay showed a complete agrement.\u00a0Elecsys HTLV\u2010I\/II assay showed 100% sensitivity (95% CI: 96.38\u2010100.0) and specificity (95% CI: 99.26\u2010100.0).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Elecsys HTLV\u2010I\/II assay is as reliable as ARCHITECT rTHLV\u2010I\/II assay, and can be used as a screening test for HTLV\u2010I\/II in Korea.<\/jats:p><\/jats:sec>","DOI":"10.1002\/jcla.22909","type":"journal-article","created":{"date-parts":[[2019,5,6]],"date-time":"2019-05-06T22:27:24Z","timestamp":1557181644000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["Evaluation of Elecsys HTLV\u2010I\/II assay in comparison with ARCHITECT rHTLV\u2010I\/II assay with Korean samples"],"prefix":"10.1002","volume":"33","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9915-9681","authenticated-orcid":false,"given":"Seung Gyu","family":"Yun","sequence":"first","affiliation":[{"name":"Department of Laboratory Medicine Korea University Hospital Seoul Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sang\u2010wook","family":"Kim","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine Korea University Hospital Seoul Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ji Yeon","family":"Sohn","sequence":"additional","affiliation":[{"name":"Department of laboratory medicine Eone Laboratories Incheon Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6942-8385","authenticated-orcid":false,"given":"Yunjung","family":"Cho","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine Korea University Hospital Seoul Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2019,5,6]]},"reference":[{"key":"e_1_2_6_2_1","doi-asserted-by":"publisher","DOI":"10.1073\/pnas.77.12.7415"},{"issue":"4","key":"e_1_2_6_3_1","doi-asserted-by":"crossref","first-page":"2456","DOI":"10.1128\/jvi.66.4.2456-2463.1992","article-title":"Multiple isolates and characteristics of human T\u2010cell leukemia virus type II","volume":"66","author":"Hall WW","year":"1992","journal-title":"J 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