Department of Laboratory Medicine, Korea University Hospital, Seoul, Korea.
Department of laboratory medicine, Eone Laboratories, Incheon, Korea.
J Clin Lab Anal. 2019 Jul;33(6):e22909. doi: 10.1002/jcla.22909. Epub 2019 May 6.
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.
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.
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).
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.
韩国献血者的人类 T 淋巴细胞病毒 I 和 II（HTLV-I/II）血清阳性率已知为 0.004%，自 2008 年以来，韩国一直在进行 HTLV-I/II Ab 筛查试验。韩国食品药品安全部（MFDS）批准了两种用于检测 HTLV-I/II 抗体的化学发光微粒子免疫分析（CMIA），即 ABBOTT PRISM HTLV-I/HTLV-II 和 ARCHITECT rHTLV-I/II。2017 年推出的用于 HTLV-I/II 抗体检测的新型电化学发光免疫分析（ECLIA） Elecsys HTLV-I/II 检测在欧洲和日本进行了多中心性能评估研究，但在韩国尚未推出。我们旨在评估 Elecsys HTLV-I/II 检测与 ARCHITECT rHTLV-I/II 检测用于检测韩国样本中的 HTLV-I/II 抗体的临床性能。
为了评估敏感性，使用了 100 份来自韩国红十字会的 HTLV-I/II 阳性韩国标准品和从 Seracure 购买的两份 HTLV-II 阳性样本。为了评估特异性，使用了来自韩国大学医院保健中心的 500 份潜在供体标本。两种 HTLV-I/II 检测，Elecsys HTLV-I/II 检测和 ARCHITECT rHTLV-I/II 检测同时对所有样本进行分析。
Elecsys HTLV-I/II 检测和 ARCHITECT rHTLV-I/II 检测完全一致。Elecsys HTLV-I/II 检测显示出 100%的敏感性（95%CI：96.38-100.0）和特异性（95%CI：99.26-100.0）。
Elecsys HTLV-I/II 检测与 ARCHITECT rTHLV-I/II 检测一样可靠，可在韩国作为 HTLV-I/II 的筛查试验使用。
