Evaluation of the New Multi-HTLV Serological Assay: Improvement for HTLV-2 Detection.

IF 1.5 4区 医学 Q4 IMMUNOLOGY
AIDS research and human retroviruses Pub Date : 2024-03-01 Epub Date: 2023-09-27 DOI:10.1089/AID.2022.0174
Victor Ângelo Folgosi, Shirley Vasconcelos Konminakis, Felipe Dias da Silva, Pedro Domingos Leite Junior, Michel Elyas Jung Haziot, Augusto C P Oliveira, Jerusa Smid, Maan Zrein, Florent Salvador, Jorge Casseb
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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.

新的多HTLV血清学检测的评价:HTLV-2检测的改进。
尽管证实性测试对人类T细胞嗜淋巴病毒(HTLV)的诊断是准确的,但在诊断人类T细胞趋淋巴病毒2型(HTLV-2)阳性患者时,仍会出现不确定或假阴性的结果。本研究的目的是评估一种验证性免疫测定法,即多HTLV测定法的灵敏度和准确性。共有246份血浆样本通过实时聚合酶链式反应(qPCR)进行了检测,并用于计算多HTLV测定的灵敏度和分型准确性。在246份血浆样本中,127份人T细胞嗜淋巴病毒1型(HTLV-1)呈阳性,112份HTLV-2呈阳性,7份HTLV-1和HTLV-2均呈阳性。此后,使用非参数Mann-Whitney U检验来计算12个qPCR结果不一致和不确定的样本的qPCR检验和多HTLV测定之间的一致性。多HTLV测定在鉴定HTLV-1和HTLV-2方面表现出高性能,灵敏度分别为97%[95%置信区间(CI):0.92-0.98]和94%(0.87-0.96)。然而,由于分型性能(HTLV-1为98%,HTLV-2为94%),它与阳性的HTLV-1qPCR结果有95%的一致性(95%CI:90.07-97.81),86%(78.04-91.01)的HTLV-2qPCR结果呈阳性。此外,该测试能够识别80%的不确定样本和所有显示假阴性qPCR结果的HTLV-2阳性样本。我们的研究结果来自大量HTLV阳性样本,强调了多重HTLV检测的内在可靠性和可行性,无论分子检测设施如何。此外,该检测的独特多参数性质,加上其直接的程序执行,为分析每位患者的特定血清学特征以及免疫监测疾病进展的潜力引入了新的视角。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
3.10
自引率
6.70%
发文量
201
审稿时长
3-6 weeks
期刊介绍: AIDS Research and Human Retroviruses was the very first AIDS publication in the field over 30 years ago, and today it is still the critical resource advancing research in retroviruses, including AIDS. The Journal provides the broadest coverage from molecular biology to clinical studies and outcomes research, focusing on developments in prevention science, novel therapeutics, and immune-restorative approaches. Cutting-edge papers on the latest progress and research advances through clinical trials and examination of targeted antiretroviral agents lead to improvements in translational medicine for optimal treatment outcomes. AIDS Research and Human Retroviruses coverage includes: HIV cure research HIV prevention science - Vaccine research - Systemic and Topical PreP Molecular and cell biology of HIV and SIV Developments in HIV pathogenesis and comorbidities Molecular biology, immunology, and epidemiology of HTLV Pharmacology of HIV therapy Social and behavioral science Rapid publication of emerging sequence information.
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