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Evaluation of Elecsys HTLV‐I/II assay in comparison with ARCHITECT rHTLV‐I/II assay with Korean samples
BACKGROUND: The seroprevalence rate of human T‐lymphotropic virus I and II (HTLV‐I/II) in Korean blood donors has been known as 0.004%, and HTLV‐I/II Ab screening test has been performed since 2008 in Korea. Korea Ministry of Food and Drug Safety (MFDS) approved two chemiluminescent microparticle im...
Autores principales: | , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6642323/ https://www.ncbi.nlm.nih.gov/pubmed/31059152 http://dx.doi.org/10.1002/jcla.22909 |
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author | Yun, Seung Gyu Kim, Sang‐wook Sohn, Ji Yeon Cho, Yunjung |
author_facet | Yun, Seung Gyu Kim, Sang‐wook Sohn, Ji Yeon Cho, Yunjung |
author_sort | Yun, Seung Gyu |
collection | PubMed |
description | BACKGROUND: The seroprevalence rate of human T‐lymphotropic virus I and II (HTLV‐I/II) in Korean blood donors has been known as 0.004%, and HTLV‐I/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‐I/II antibody, ABBOTT PRISM HTLV‐I/HTLV‐II and ARCHITECT rHTLV‐I/II. A multicenter performance evaluation study in Europe and Japan was carried out with the new electrochemiluminescence immunoassay (ECLIA) for HTLV‐I/II antibody detection, Elecsys HTLV‐I/II assay which launched in 2017, but not in Korea. We aimed to evaluate the clinical performance of Elecsys HTLV‐I/II assay in comparison with ARCHITECT rHTLV‐I/II for the detection of HTLV‐I/II antibody with Korean samples. METHODS: For sensitivity evaluation, 100 HTLV‐I/II‐positive Korean standards from Korean Red Cross and two HTLV‐II‐positive samples that were purchased 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‐I/II assays, Elecsys HTLV‐I/II assay and ARCHITECT rHTLV‐I/II assay. RESULTS: Elecsys HTLV‐I/II assay and ARCHITECT rHTLV‐I/II assay showed a complete agrement. Elecsys HTLV‐I/II assay showed 100% sensitivity (95% CI: 96.38‐100.0) and specificity (95% CI: 99.26‐100.0). CONCLUSIONS: Elecsys HTLV‐I/II assay is as reliable as ARCHITECT rTHLV‐I/II assay, and can be used as a screening test for HTLV‐I/II in Korea. |
format | Online Article Text |
id | pubmed-6642323 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-66423232019-11-12 Evaluation of Elecsys HTLV‐I/II assay in comparison with ARCHITECT rHTLV‐I/II assay with Korean samples Yun, Seung Gyu Kim, Sang‐wook Sohn, Ji Yeon Cho, Yunjung J Clin Lab Anal Research Articles BACKGROUND: The seroprevalence rate of human T‐lymphotropic virus I and II (HTLV‐I/II) in Korean blood donors has been known as 0.004%, and HTLV‐I/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‐I/II antibody, ABBOTT PRISM HTLV‐I/HTLV‐II and ARCHITECT rHTLV‐I/II. A multicenter performance evaluation study in Europe and Japan was carried out with the new electrochemiluminescence immunoassay (ECLIA) for HTLV‐I/II antibody detection, Elecsys HTLV‐I/II assay which launched in 2017, but not in Korea. We aimed to evaluate the clinical performance of Elecsys HTLV‐I/II assay in comparison with ARCHITECT rHTLV‐I/II for the detection of HTLV‐I/II antibody with Korean samples. METHODS: For sensitivity evaluation, 100 HTLV‐I/II‐positive Korean standards from Korean Red Cross and two HTLV‐II‐positive samples that were purchased 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‐I/II assays, Elecsys HTLV‐I/II assay and ARCHITECT rHTLV‐I/II assay. RESULTS: Elecsys HTLV‐I/II assay and ARCHITECT rHTLV‐I/II assay showed a complete agrement. Elecsys HTLV‐I/II assay showed 100% sensitivity (95% CI: 96.38‐100.0) and specificity (95% CI: 99.26‐100.0). CONCLUSIONS: Elecsys HTLV‐I/II assay is as reliable as ARCHITECT rTHLV‐I/II assay, and can be used as a screening test for HTLV‐I/II in Korea. John Wiley and Sons Inc. 2019-05-06 /pmc/articles/PMC6642323/ /pubmed/31059152 http://dx.doi.org/10.1002/jcla.22909 Text en © 2019 The Authors. Journal of Clinical Laboratory Analysis Published by Wiley Periodicals, Inc. This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes. |
spellingShingle | Research Articles Yun, Seung Gyu Kim, Sang‐wook Sohn, Ji Yeon Cho, Yunjung Evaluation of Elecsys HTLV‐I/II assay in comparison with ARCHITECT rHTLV‐I/II assay with Korean samples |
title | Evaluation of Elecsys HTLV‐I/II assay in comparison with ARCHITECT rHTLV‐I/II assay with Korean samples |
title_full | Evaluation of Elecsys HTLV‐I/II assay in comparison with ARCHITECT rHTLV‐I/II assay with Korean samples |
title_fullStr | Evaluation of Elecsys HTLV‐I/II assay in comparison with ARCHITECT rHTLV‐I/II assay with Korean samples |
title_full_unstemmed | Evaluation of Elecsys HTLV‐I/II assay in comparison with ARCHITECT rHTLV‐I/II assay with Korean samples |
title_short | Evaluation of Elecsys HTLV‐I/II assay in comparison with ARCHITECT rHTLV‐I/II assay with Korean samples |
title_sort | evaluation of elecsys htlv‐i/ii assay in comparison with architect rhtlv‐i/ii assay with korean samples |
topic | Research Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6642323/ https://www.ncbi.nlm.nih.gov/pubmed/31059152 http://dx.doi.org/10.1002/jcla.22909 |
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