Evaluation of Sensitivity and Specificity Performance of Elecsys HTLV-I/II Assay in a Multicenter Study in Europe and Japan.

Autor:	Laperche S; Institut National de la Transfusion Sanguine (INTS), Département des agents transmissibles par le sang, Centre National de Référence Risques Infectieux Transfusionnels, Paris, France slaperche@ints.fr., Sauleda S; Banc de Sang i Teixits, Barcelona, Spain., Piron M; Banc de Sang i Teixits, Barcelona, Spain., Mühlbacher A; Central Institute for Blood Transfusion and Immunology, University Hospital, Innsbruck, Austria., Schennach H; Central Institute for Blood Transfusion and Immunology, University Hospital, Innsbruck, Austria., Schottstedt V; DRK Blutspendedienst West Central Laboratory, Hagen, Germany., Queirós L; Instituto Português do Sangue e da Transplantação, Porto, Portugal., Uno N; Department of Laboratory Medicine, Nagasaki University Hospital, Nagasaki, Japan., Yanagihara K; Department of Laboratory Medicine, Nagasaki University Hospital, Nagasaki, Japan., Imdahl R; Labor Schottdorf MVZ, Augsburg, Germany., Hey A; Labor Schottdorf MVZ, Augsburg, Germany., Klinkicht M; Roche Diagnostics, Penzberg, Germany., Melchior W; Roche Diagnostics, Penzberg, Germany., Muench P; Roche Diagnostics, Penzberg, Germany., Watanabe T; Graduate School of Frontier Sciences, University of Tokyo, Tokyo, Japan.; Department of Advanced Medical Innovation, St. Marianna University Graduate School of Medicine, Kanagawa, Japan.
Jazyk:	angličtina
Zdroj:	Journal of clinical microbiology [J Clin Microbiol] 2017 Jul; Vol. 55 (7), pp. 2180-2187. Date of Electronic Publication: 2017 May 03.
DOI:	10.1128/JCM.00169-17
Abstrakt:	Screening of blood for human T-cell lymphotropic virus type 1 and type 2 (HTLV-1 and -2, respectively) is important to diagnose and prevent infection and ensure the safety of blood supplies. The Elecsys HTLV-I/II assay is a newly developed, electrochemiluminescence screening assay for the detection of HTLV-1/2 infection. The sensitivity and specificity of the Elecsys HTLV-I/II assay were determined using well-characterized HTLV-1/2-positive serum and plasma samples and routine diagnostic and blood donor samples expected to be HTLV negative, respectively. These results were compared with those for at least one of the following CE-marked assays at seven independent laboratories and the Roche Diagnostics facility in Penzberg, Germany: Abbott Architect rHTLV-I/II, Ortho Avioq HTLV-I/II Microelisa system, Abbott Prism HTLV-I/HTLV-II, and DiaSorin Murex HTLV I+II. Fujirebio INNO-LIA HTLV-I/II Score was used as a confirmatory assay. The Elecsys HTLV-I/II, Abbott Architect rHTLV-I/II, and Abbott Prism HTLV-I/HTLV-II assays detected all HTLV-1/2-positive samples (sensitivity, 100%). Sensitivity for Ortho Avioq HTLV-I/II was 98.63%. The Elecsys HTLV-I/II assay had a specificity of 99.95% in blood donor samples, which was comparable to results for the other assays (range, 99.91 to 100%). In routine diagnostic samples, the specificity of the Elecsys HTLV-I/II assay was 99.83%, compared with 99.70% for Abbott Architect rHTLV-I/II. Specificity for the Elecsys HTLV-I/II assay in potentially cross-reactive samples was 100%, compared with 99.0% for Ortho Avioq HTLV-I/II and 99.2% for DiaSorin Murex HTLV I+II. The Elecsys HTLV-I/II assay has the sensitivity and specificity to support its use as a routine screening assay for detecting HTLV infection. (Copyright © 2017 Laperche et al.)
Databáze:	MEDLINE
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