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Abstract：
Talaromycosis is an invasive mycosis endemic in Southeast Asia and causes substantial morbidity and mortality in individuals with advanced human immunodeficiency virus (HIV) disease. Current diagnosis relies on isolating Talaromyces marneffei in cultures, which takes up to 14 days and is detectable only during late-stage infection, leading to high mortality.
In this retrospective case-control study, we assessed the accuracy of a novel Mp1p antigen-detecting enzyme immunoassay (EIA) in stored plasma samples of 372 patients who had culture-proven talaromycosis from blood or sterile body fluids (reference standard) and 517 individuals without talaromycosis (338 healthy volunteers; 179 with other infections). All participants were recruited between 2011 and 2017 in Vietnam.
Of cases and controls, 66.1% and 75.4%, respectively, were male; the median age was 33 and 37, respectively. All cases were HIV infected; median CD4 count was 10 cells/μL. At an optical density cutoff of 0.5, the specificity was 98.1% (95% CI, 96.3%-99.0%); the sensitivity was superior to blood culture (86.3% [95% CI, 82.3%-89.5%] vs 72.8% [95% CI, 68.0%-77.2%]) (P < .001, McNemar test). The time to diagnosis was 6 hours vs 6.6 ± 3.0 days for blood culture. Paired plasma and urine testing in the same patients (n = 269) significantly increased sensitivity compared to testing plasma alone or testing urine alone (P < .001 and P = .02, respectively, McNemar test).
The Mp1p EIA is highly specific and is superior in sensitivity and time to diagnosis compared to blood culture for the diagnosis of talaromycosis. Paired plasma and urine testing further increases sensitivity, introducing a new tool for rapid diagnosis, enabling early treatment and potentially reducing mortality.
In this retrospective case-control study, we assessed the accuracy of a novel Mp1p antigen-detecting enzyme immunoassay (EIA) in stored plasma samples of 372 patients who had culture-proven talaromycosis from blood or sterile body fluids (reference standard) and 517 individuals without talaromycosis (338 healthy volunteers; 179 with other infections). All participants were recruited between 2011 and 2017 in Vietnam.
Of cases and controls, 66.1% and 75.4%, respectively, were male; the median age was 33 and 37, respectively. All cases were HIV infected; median CD4 count was 10 cells/μL. At an optical density cutoff of 0.5, the specificity was 98.1% (95% CI, 96.3%-99.0%); the sensitivity was superior to blood culture (86.3% [95% CI, 82.3%-89.5%] vs 72.8% [95% CI, 68.0%-77.2%]) (P < .001, McNemar test). The time to diagnosis was 6 hours vs 6.6 ± 3.0 days for blood culture. Paired plasma and urine testing in the same patients (n = 269) significantly increased sensitivity compared to testing plasma alone or testing urine alone (P < .001 and P = .02, respectively, McNemar test).
The Mp1p EIA is highly specific and is superior in sensitivity and time to diagnosis compared to blood culture for the diagnosis of talaromycosis. Paired plasma and urine testing further increases sensitivity, introducing a new tool for rapid diagnosis, enabling early treatment and potentially reducing mortality.
摘要：
塔拉真菌病是东南亚的一种侵袭性真菌病，在患有晚期人类免疫缺陷病毒（HIV）疾病的个体中引起大量发病率和死亡率。目前的诊断依赖于在培养物中分离马尔尼菲塔拉酵母，这需要长达14天，只有在晚期感染期间才能检测到，导致高死亡率。
在这项回顾性病例对照研究中，我们评估了一种新型Mp1p抗原检测酶免疫测定法(EIA)在储存的血浆样本中的准确性,该样本为372例经血液或无菌体液培养证实的塔拉真菌病患者(参考标准)和517例非塔拉真菌病患者(338例健康志愿者;179例其他感染).所有参与者都是在2011年至2017年期间在越南招募的。
案件和控制，66.1%和75.4%，分别,均为男性；中位年龄分别为33岁和37岁。所有病例均为HIV感染；中位CD4计数为10个细胞/μL。在0.5的光密度截止值下，特异性为98.1％（95％CI，96.3％-99.0％）；敏感性优于血培养（86.3％[95％CI，82.3％-89.5％]vs72.8％[95％CI，68.0％-77.2％]）（P<.001，McNemar检验）。诊断时间为6小时，而血液培养为6.6±3.0天。与单独检测血浆或单独检测尿液相比，同一患者（n=269）的血浆和尿液配对检测的敏感性显着提高（P<.001和P=.02，分别，McNemar测试)。
与血培养相比，Mp1pEIA具有高度特异性，诊断灵敏度和诊断时间优于血培养，可用于诊断真菌病。配对的血浆和尿液检测进一步提高了灵敏度，引入一种快速诊断的新工具，能够早期治疗并有可能降低死亡率。
在这项回顾性病例对照研究中，我们评估了一种新型Mp1p抗原检测酶免疫测定法(EIA)在储存的血浆样本中的准确性,该样本为372例经血液或无菌体液培养证实的塔拉真菌病患者(参考标准)和517例非塔拉真菌病患者(338例健康志愿者;179例其他感染).所有参与者都是在2011年至2017年期间在越南招募的。
案件和控制，66.1%和75.4%，分别,均为男性；中位年龄分别为33岁和37岁。所有病例均为HIV感染；中位CD4计数为10个细胞/μL。在0.5的光密度截止值下，特异性为98.1％（95％CI，96.3％-99.0％）；敏感性优于血培养（86.3％[95％CI，82.3％-89.5％]vs72.8％[95％CI，68.0％-77.2％]）（P<.001，McNemar检验）。诊断时间为6小时，而血液培养为6.6±3.0天。与单独检测血浆或单独检测尿液相比，同一患者（n=269）的血浆和尿液配对检测的敏感性显着提高（P<.001和P=.02，分别，McNemar测试)。
与血培养相比，Mp1pEIA具有高度特异性，诊断灵敏度和诊断时间优于血培养，可用于诊断真菌病。配对的血浆和尿液检测进一步提高了灵敏度，引入一种快速诊断的新工具，能够早期治疗并有可能降低死亡率。
