Abstract：
Despite the accuracy of confirmatory tests for the diagnosis of human T cell lymphotropic virus (HTLV), inconclusive or false-negative results still occur when diagnosing human T cell lymphotropic virus type 2 (HTLV-2)-positive patients. The goal of this study was to evaluate the sensitivity and accuracy of a confirmatory immunoassay, the Multi-HTLV assay. A total of 246 plasma samples were tested by real-time polymerase chain reaction (qPCR) and used to calculate the sensitivity and typing accuracy of the Multi-HTLV assay. Of the 246 plasma samples, 127 were positive for human T cell lymphotropic virus type 1 (HTLV-1), 112 were positive for HTLV-2, and 7 were positive for both HTLV-1 and HTLV-2. Thereafter, the nonparametric Mann-Whitney U test was used to calculate the concordance between the qPCR test and Multi-HTLV assay in 12 samples with discrepant and inconclusive qPCR results. The Multi-HTLV assay showed high performance in identifying HTLV-1 and HTLV-2 with sensitivities of 97% [95% confidence interval (CI): 0.92-0.98] and 94% (0.87-0.96), respectively. However, due to typing performance (98% for HTLV-1 and 94% for HTLV-2), it had 95% agreement with positive HTLV-1 qPCR results (95% CI: 90.07-97.81) and 86% (78.04-91.01) of HTLV-2 qPCR results were positive. Moreover, this test was able to recognize 80% of indeterminate samples and all HTLV-2 positive samples that showed false-negative qPCR results. Our findings, derived from a substantial number of HTLV-positive samples, underscore the inherent reliability and feasibility of the Multi-HTLV assay, regardless of the molecular testing facilities. Furthermore, the distinctive multiparametric nature of this assay, combined with its straightforward procedural execution, introduces novel perspectives for analyzing specific serological profiles in each patient, as well as the potential for immunological monitoring of disease progression.
摘要：
背景：尽管用于诊断HTLV的确证试验的准确性，在诊断HTLV-2阳性患者时，仍然会出现不确定的或假阴性的结果。这项研究的目的是评估验证性免疫测定的敏感性和准确性，多HTLV测试。
方法：通过qPCR测试了总共246个血浆样品，并用于计算Multi-HTLV测试的灵敏度和分型准确性。在246名患者中，有127名HTLV-1阳性，112名HTLV-2阳性，7名HTLV-1和HTLV-2阳性。此后,非参数Mann-WhitneyU检验用于计算qPCR检验和Multi-HTLV在12个qPCR结果不一致和不确定的样本中的一致性.
结果：Multi-HTLV分析显示出鉴定HTLV-1和HTLV-2的高性能，敏感性为97％（95％CI：0.92-0.98）和94％（0.87-0.96），分别。然而,由于分型性能（HTLV-1为98％，HTLV-2为94％），它与HTLV-1qPCR结果阳性（95％CI：90.07-97.81）和HTLV-2qPCR结果阳性的86％（78.04-91.01）具有95％的一致性。此外，这项检测能够识别80%的不确定样本和所有显示假阴性qPCR结果的HTLV-2阳性.
结论：本研究旨在评估Multi-HTLV测试的敏感性和准确性。这项研究的结果表明，与包括Multi-HTLV的血清学技术相比，qPCR对HTLV-1/2的诊断更准确。研究表明，与相同的诊断技术相比，确认血清学结果（WB或LIA），呈现与多重/ELISA相似或较差的结果，主要在HTLV-2的诊断。多HTLV测试，由于它的多参数性质，并且由于它易于执行，为研究每位患者的特定血清学特征和疾病进展的免疫监测提供了新的见解。
方法：通过qPCR测试了总共246个血浆样品，并用于计算Multi-HTLV测试的灵敏度和分型准确性。在246名患者中，有127名HTLV-1阳性，112名HTLV-2阳性，7名HTLV-1和HTLV-2阳性。此后,非参数Mann-WhitneyU检验用于计算qPCR检验和Multi-HTLV在12个qPCR结果不一致和不确定的样本中的一致性.
结果：Multi-HTLV分析显示出鉴定HTLV-1和HTLV-2的高性能，敏感性为97％（95％CI：0.92-0.98）和94％（0.87-0.96），分别。然而,由于分型性能（HTLV-1为98％，HTLV-2为94％），它与HTLV-1qPCR结果阳性（95％CI：90.07-97.81）和HTLV-2qPCR结果阳性的86％（78.04-91.01）具有95％的一致性。此外，这项检测能够识别80%的不确定样本和所有显示假阴性qPCR结果的HTLV-2阳性.
结论：本研究旨在评估Multi-HTLV测试的敏感性和准确性。这项研究的结果表明，与包括Multi-HTLV的血清学技术相比，qPCR对HTLV-1/2的诊断更准确。研究表明，与相同的诊断技术相比，确认血清学结果（WB或LIA），呈现与多重/ELISA相似或较差的结果，主要在HTLV-2的诊断。多HTLV测试，由于它的多参数性质，并且由于它易于执行，为研究每位患者的特定血清学特征和疾病进展的免疫监测提供了新的见解。
