Integrated and Multidisciplinary HTLV Center, Bahiana School of Medicine and Public Health (EBMSP), Salvador, Bahia, Brazil.
Advanced Laboratory of Public Health, Gonçalo Moniz Institute (IGM), FIOCRUZ-BA, Salvador, Bahia, Brazil.
J Clin Microbiol. 2018 Nov 27;56(12). doi: 10.1128/JCM.00961-18. Print 2018 Dec.
Serological screening for human T-cell lymphotropic virus type 1 (HTLV-1) is usually performed using enzyme-linked immunosorbent assay (ELISA), particle agglutination, or chemiluminescence assay kits. Due to an antigen matrix improvement entailing the use of new HTLV antigens and changes in the format of HTLV screening tests, as well as newly introduced chemiluminescence assays (CLIAs), a systematic evaluation of the accuracy of currently available commercial tests is warranted. We aimed to assess the performance of commercially available screening tests for HTLV infection diagnosis. A diagnostic accuracy study was conducted on a panel of 397 plasma samples: 200 HTLV-negative plasma samples, 170 HTLV-positive plasma samples, and 27 plasma samples indeterminate by Western blotting (WB). WB-indeterminate samples (i.e., those yielding no specific bands for HTLV-1 and/or HTLV-2) were assessed by PCR, and the results were used to compare agreement among the commercially available ELISA screening tests. For performance analysis, WB-indeterminate samples were excluded, resulting in a final study panel of 370 samples. Three ELISA kits (Murex HTLV-1/2 [Murex], anti-HTLV-1/2 SYM Solution [SYM Solution], and Gold ELISA HTLV-1/2 [Gold ELISA]) and one CLIA kit (Architect rHTLV-1/2) were evaluated. All screening tests demonstrated 100% sensitivity. Concerning the HTLV-negative samples, the SYM Solution and Gold ELISA kits had specificity values of >99.5%, while the Architect rHTLV-1/2 test presented 98.1% specificity, followed by Murex, which had a specificity of 92.0%. Regarding the 27 samples with WB-indeterminate results, after PCR confirmation, all ELISA kits showed 100% sensitivity but low specificity. Accuracy findings were corroborated by the use of Cohen's kappa value, which evidenced slight and fair agreement between PCR analysis and ELISAs for HTLV infection diagnosis. Based on the data, we believe that all evaluated tests can be safely used for HTLV infection screening.
血清学筛查人 T 细胞嗜淋巴细胞病毒 1 型（HTLV-1）通常使用酶联免疫吸附试验（ELISA）、颗粒凝集或化学发光测定试剂盒进行。由于抗原基质的改进，涉及使用新的 HTLV 抗原和 HTLV 筛选试验格式的变化，以及新引入的化学发光测定法（CLIAs），有必要对当前可用的商业检测进行系统评估。我们旨在评估现有的用于 HTLV 感染诊断的商业筛选检测的性能。在一个 397 个血浆样本的小组中进行了诊断准确性研究：200 个 HTLV-阴性血浆样本、170 个 HTLV-阳性血浆样本和 27 个 Western 印迹（WB）不确定的血浆样本。WB 不确定样本（即未产生 HTLV-1 和/或 HTLV-2 特定条带的样本）通过 PCR 进行评估，并将结果用于比较市售 ELISA 筛选检测之间的一致性。对于性能分析，排除了 WB 不确定的样本，最终研究小组有 370 个样本。评估了三种 ELISA 试剂盒（Murex HTLV-1/2 [Murex]、anti-HTLV-1/2 SYM Solution [SYM Solution]和 Gold ELISA HTLV-1/2 [Gold ELISA]）和一种 CLIA 试剂盒（Architect rHTLV-1/2）。所有筛选试验均显示 100%的敏感性。对于 HTLV-阴性样本，SYM Solution 和 Gold ELISA 试剂盒的特异性值>99.5%，而 Architect rHTLV-1/2 试验的特异性为 98.1%，其次是 Murex，特异性为 92.0%。对于 27 个 WB 不确定结果的样本，在 PCR 确认后，所有 ELISA 试剂盒均显示 100%的敏感性，但特异性较低。准确性发现得到了 Cohen's kappa 值的证实，该值表明 PCR 分析与 ELISAs 之间对 HTLV 感染诊断具有轻微和适度的一致性。根据这些数据，我们认为所有评估的检测都可以安全地用于 HTLV 感染筛查。
