Barwatt Joseph, Brown Lottie, Thu Nguyen Thi Mai, Gonzalez Paula, Venugopalan Sruthi, Sambath Heera Natesan, Hoa Ngo Thi, Cai Jian-Piao, Yuen Kwok-Yung, Chan Jasper Fuk-Woo, Ly Vo Trieu, Le Thuy
Division of Infectious Disease and International Health, Duke University School of Medicine, Durham, North Carolina, United States of America.
Institute of Infection and Immunity, City St George's University, School of Health & Medical Sciences, London, United Kingdom.
PLoS Negl Trop Dis. 2025 Aug 1;19(8):e0013248. doi: 10.1371/journal.pntd.0013248. eCollection 2025 Aug.
Several antigen-detection assays have been developed for the rapid diagnosis of talaromycosis, but their utility has been limited by a lack of commercial options. The aim of this study was to perform a head-to-head comparison of the performance of our in-house monoclonal antibody-based Mp1p antigen-detecting enzyme immunoassay (EIA) with its recently-developed commercial platform.
In this diagnostic accuracy, retrospective, case-cohort study, we compared the sensitivity, specificity, positive likelihood ratio (LR+) and negative likelihood ratio (LR-) of the commercial Wantai Mp1p EIA versus our in-house Mp1p EIA on paired plasma and urine samples from 424 hospitalized adults with advanced HIV disease, including 224 cases of proven talaromycosis, where Talaromyces marneffei was isolated in culture of blood or other clinical specimens, and 200 controls diagnosed with a range of other opportunistic infections. All participants were randomly selected from prospective cohorts recruited between 2011 and 2019 from five centers in Vietnam.
The sensitivity of the Wantai and in-house Mp1p EIAs were comparable in plasma (95.1% vs 92.4%, P = 0.11), in urine (91.5% vs 87.1% P = 0.07), and in combined testing of plasma and urine (96.4% vs 96.0%, P = 1.00), where talaromycosis was diagnosed based on the positivity of either specimen. The specificity of the Wantai and in-house Mp1p EIAs were consistently high in plasma, in urine, and in combined testing (93 - 97%). The Wantai and in-house Mp1p EIAs provided substantially higher sensitivity than blood culture detection (96.4% and 96.0% vs 78.6%, P < 0.001). For both EIAs, LR+ were greater than 10 and LR- were less than 0.1, which increases the confidence to rule in or rule out talaromycosis.
The diagnostic performance of the Wantai Mp1p EIA was comparable to our validated in-house Mp1p EIA, and significantly more sensitive than blood culture, offering a standardized tool for the rapid diagnosis of talaromycosis.
已经开发了几种抗原检测方法用于快速诊断马尔尼菲篮状菌病，但由于缺乏商业产品，其应用受到限制。本研究的目的是对我们基于单克隆抗体的内部Mp1p抗原检测酶免疫测定法（EIA）与最近开发的商业平台的性能进行直接比较。
在这项诊断准确性的回顾性病例队列研究中，我们比较了万泰Mp1p EIA与我们的内部Mp1p EIA在424例患有晚期HIV疾病的住院成人的配对血浆和尿液样本中的敏感性、特异性、阳性似然比（LR+）和阴性似然比（LR-），其中包括224例经证实的马尔尼菲篮状菌病病例，这些病例在血液或其他临床标本培养中分离出马尔尼菲篮状菌，以及200例被诊断患有一系列其他机会性感染的对照。所有参与者均从2011年至2019年期间从越南五个中心招募的前瞻性队列中随机选择。
万泰Mp1p EIA和内部Mp1p EIA在血浆中的敏感性相当（95.1%对92.4%，P = 0.11），在尿液中（91.5%对87.1%，P = 0.07），以及在血浆和尿液联合检测中（96.4%对96.0%，P = 1.00），其中马尔尼菲篮状菌病根据任一标本的阳性结果进行诊断。万泰Mp1p EIA和内部Mp1p EIA在血浆、尿液及联合检测中的特异性始终很高（93 - 97%）。万泰Mp1p EIA和内部Mp1p EIA提供的敏感性显著高于血培养检测（96.4%和96.0%对78.6%，P < 0.001）。对于两种EIA，LR+均大于10且LR-均小于0.1，这增加了确诊或排除马尔尼菲篮状菌病的信心。
万泰Mp1p EIA的诊断性能与我们经过验证的内部Mp1p EIA相当，且比血培养显著更敏感，为马尔尼菲篮状菌病的快速诊断提供了一种标准化工具。
