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首页> 外文期刊>Journal of Clinical Microbiology >Performance of Commercially Available Serological Screening Tests for Human T-Cell Lymphotropic Virus Infection in Brazil
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Performance of Commercially Available Serological Screening Tests for Human T-Cell Lymphotropic Virus Infection in Brazil

机译：在巴西对人T细胞淋巴病毒感染的市售血清学筛查测试的性能

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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. ABSTRACT 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.
机译：通常使用酶联免疫吸附测定（ELISA），颗粒凝集或化学发光测定试剂盒对1型人T细胞淋巴病毒（HTLV-1）进行血清学筛查。由于抗原基质的改进，需要使用新的HTLV抗原，并且HTLV筛选测试的格式有所变化，以及新引入的化学发光分析（CLIA），因此有必要对目前可用的商业测试的准确性进行系统评估。摘要通常使用酶联免疫吸附测定（ELISA），颗粒凝集或化学发光测定试剂盒对1型人T细胞淋巴病毒（HTLV-1）进行血清学筛查。由于抗原基质的改进，需要使用新的HTLV抗原，并且HTLV筛选测试的格式有所变化，以及新引入的化学发光分析（CLIA），因此有必要对目前可用的商业测试的准确性进行系统评估。我们旨在评估用于HTLV感染诊断的市售筛选测试的性能。对397个血浆样品进行了诊断准确性研究：200个HTLV阴性血浆样品，170个HTLV阳性血浆样品和27个通过Western blotting（WB）不确定的血浆样品。通过PCR评估WB不确定的样品（即那些不产生HTLV-1和/或HTLV-2特异性条带的样品），并将结果用于比较市售ELISA筛选测试之间的一致性。为了进行性能分析，排除了WB不确定的样品，从而形成了370个样品的最终研究小组。三种ELISA试剂盒（Murex HTLV-1 / 2 [Murex]，抗HTLV-1 / 2 SYM溶液[SYM Solution]和Gold ELISA HTLV-1 / 2 [Gold ELISA]）和一种CLIA试剂盒（Architect rHTLV-1 / 2）。所有筛选测试均显示100％的敏感性。关于HTLV阴性样品，SYM溶液和Gold ELISA试剂盒的特异性值为＞ 99.5％，而Architect rHTLV-1 / 2测试的特异性为98.1％，其次是Murex，其特异性为92.0％。对于具有WB不确定结果的27个样品，PCR确认后，所有ELISA试剂盒均显示出100％的敏感性，但特异性较低。使用Cohen的kappa值证实了准确性的发现，这证明了PCR分析和ELISA在HTLV感染诊断中的轻微和合理的一致性。根据这些数据，我们认为所有评估的测试都可以安全地用于HTLV感染筛查。

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