Evaluation of Elecsys HTLV-I/II assay in comparison with ARCHITECT rHTLV-I/II assay with Korean samples

Seung Gyu Yun, Sang wook Kim, Ji Yeon Sohn, Yunjung Cho

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish
Article numbere22909
JournalJournal of Clinical Laboratory Analysis
Volume33
Issue number6
DOIs
Publication statusPublished - 2019 Jul 1

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Human T-lymphotropic virus 2
Viruses
Assays
Korea
HTLV-II Antibodies
Human T-lymphotropic virus 1
Immunoassay
Screening
Red Cross
Antibodies
Food Safety
Seroepidemiologic Studies
Blood Donors

Keywords

  • blood donor screening
  • clinical performance
  • HTLV-I/II
  • Korean

ASJC Scopus subject areas

  • Immunology and Allergy
  • Hematology
  • Public Health, Environmental and Occupational Health
  • Clinical Biochemistry
  • Medical Laboratory Technology
  • Biochemistry, medical
  • Microbiology (medical)

Cite this

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.

In: Journal of Clinical Laboratory Analysis, Vol. 33, No. 6, e22909, 01.07.2019.

Research output: Contribution to journalArticle

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title = "Evaluation of Elecsys HTLV-I/II assay in comparison with ARCHITECT rHTLV-I/II assay with Korean samples",
abstract = "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.",
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AU - Yun, Seung Gyu

AU - Kim, Sang wook

AU - Sohn, Ji Yeon

AU - Cho, Yunjung

PY - 2019/7/1

Y1 - 2019/7/1

N2 - 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.

AB - 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.

KW - blood donor screening

KW - clinical performance

KW - HTLV-I/II

KW - Korean

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JO - Journal of Clinical Laboratory Analysis

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