{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,25]],"date-time":"2025-10-25T12:00:48Z","timestamp":1761393648354},"reference-count":49,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2008,1,18]],"date-time":"2008-01-18T00:00:00Z","timestamp":1200614400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Journal of Medical Virology"],"published-print":{"date-parts":[[2008,3]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Screening blood donations for human T\u2010lymphotropic virus types I and II (HTLV\u2010I\/II) continues to be important in protecting the safety of blood products and controlling the global spread of these retroviruses. We have developed a fully automated, third generation chemiluminescent immunoassay, ARCHITECT rHTLV\u2010I\/II, for detection of antibodies to HTLV\u2010I\/II. The assay utilizes recombinant proteins and synthetic peptides and is configured in a double antigen sandwich assay format. Specificity of the assay was 99.98% (9,254\/9,256, 95% CI\u2009=\u200999.92\u2013100%) with the negative specimens from the general population including blood donors, hospital patients and pregnant women from the US, Japan and Nicaragua. The assay demonstrated 100% sensitivity by detecting 498 specimens from individuals infected with HTLV\u2010I (n\u2009=\u2009385) and HTLV\u2010II (n\u2009=\u2009113). ARCHITECT rHTLV\u2010I\/II results were in complete agreement with the Murex HTLV\u2010I\/II reference assay and 99.7% agreement with the Genelabs HTLV Blot 2.4 confirmatory assay. Analytical sensitivity of the assay was equivalent to Murex HTLV\u2010I\/II assay based on end point dilutions. Furthermore, using a panel of 397 specimens from Japan, the ARCHITECT rHTLV\u2010I\/II assay exhibited distinct discrimination between the antibody negative (Delta Value\u2009=\u2009\u22127.6) and positive (Delta Value\u2009=\u20097.6) populations. Based on the excellent specificity and sensitivity, the new ARCHITECT rHTLV\u2010I\/II assay should be an effective test for the diagnosis of HTLV\u2010I\/II infection and also for blood donor screening. J. Med. Virol. 80:484\u2013493, 2008. \u00a9 2008 Wiley\u2010Liss, Inc.<\/jats:p>","DOI":"10.1002\/jmv.21083","type":"journal-article","created":{"date-parts":[[2008,1,19]],"date-time":"2008-01-19T01:46:31Z","timestamp":1200707191000},"page":"484-493","source":"Crossref","is-referenced-by-count":27,"title":["Evaluation of a new, fully automated immunoassay for detection of HTLV\u2010I and HTLV\u2010II 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