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Diagnostic accuracy cohort study and clinical value of the Histoplasma urine antigen (ALPHA Histoplasma EIA) for disseminated histoplasmosis among HIV infected patients: A multicenter study
PLOS Neglected Tropical Diseases ( IF 3.4 ) Pub Date : 2018-11-05 , DOI: 10.1371/journal.pntd.0006872
Pedro Torres-González , María Dolores Niembro-Ortega , Areli Martínez-Gamboa , Víctor Hugo Ahumada-Topete , Jaime Andrade-Villanueva , Javier Araujo-Meléndez , Alberto Chaparro-Sánchez , Brenda Crabtree-Ramírez , Sofia Cruz-Martínez , Armando Gamboa-Domínguez , Oscar I. Flores-Barrientos , Jesús Enrique Gaytán-Martínez , Luz Alicia González-Hernández , Christian Hernández-León , Víctor Hugo Lozano-Fernandez , Marisol Manríquez-Reyes , Martin Magaña-Aquino , Pedro Martínez-Ayala , Juan Pablo Ramírez-Hinojosa , Andrea Rangel-Cordero , Norma Erendira Rivera-Martínez , Edgardo Reyes-Gutiérrez , Gustavo Reyes-Terán , Patricia Rodríguez-Zulueta , Jesús Ruíz-Quiñones , Janeth Santiago-Cruz , Nancy Guadalupe Velázquez-Zavala , José Sifuentes-Osornio , Alfredo Ponce de León

Background

The Histoplasma urine antigen (HUAg) is the preferred method to diagnose progressive disseminated histoplasmosis (PDH) in HIV patients. In 2007, IMMY ALPHA Histoplasma EIA was approved for clinical for on-site use, and therefore useful for regions outside the United States. However, ALPHA-HUAg is considered inferior to the MVista-HUAg which is only available on referral. We aim to evaluate the diagnostic accuracy of ALPHA-HUAg.

Methodology/Principal findings

We conducted a multicenter, prospective, diagnostic test study in two secondary and eight tertiary-care facilities in Mexico. We included HIV patient with PDH suspicion and evaluated ALPHA-HUAg diagnostic accuracy using as reference standard the Histoplasma capsulatum growth on blood, bone marrow, and tissue cultures or compatible histopathologic exam (PDH–proven). We evaluated the results of 288 patients, 29.5% (85/288; 95% confidence interval [CI], 24.3–35.1) had PDH. The sensitivity of ALPHA-HUAg was 67.1% (95% CI, 56–76.8%) and the specificity was 97.5% (95% CI, 94.3%-99.1%). The positive likelihood ratio was 27.2 (95% CI; 11.6–74.4). In 10.5% of the PDH–proven patients, a co-existing opportunistic infection was diagnosed, mostly disseminated Mycobacterium avium complex infection.

Conclusions/Significance

We observed a high specificity but low sensitivity of IMMY-HUAg. The test may be useful to start early antifungals, but a culture-based approach is necessary since co-infections are frequent and a negative IMMY-HUAg result does not rule out PDH.



中文翻译:

一项多中心研究:组织浆尿抗原(ALPHA组织浆EIA)对HIV感染者中传播性组织病的诊断准确性队列研究和临床价值

背景

组织浆尿抗原(HUAg)是诊断HIV患者进行性播散性组织胞浆病(PDH)的首选方法。2007年,IMMY ALPHA组织胞浆EIA被批准用于临床现场使用,因此可用于美国以外的地区。但是,ALPHA-HUAg被认为不如MVista-HUAg逊色,后者仅在转诊时才可用。我们旨在评估ALPHA-HUAg的诊断准确性。

方法/主要发现

我们在墨西哥的两个二级和八个三级医疗机构中进行了一项多中心,前瞻性,诊断性测试研究。我们将怀疑患有PDH的HIV患者纳入研究范围,并使用血液,骨髓和组织培养上的组织胞浆囊生长或经过组织病理学检查(PDH验证)作为参考标准,对ALPHA-HUAg的诊断准确性进行了评估。我们评估了288例患者的结果,其中29.5%(85/288; 95%置信区间[CI],24.3–35.1)有PDH。ALPHA-HUAg的敏感性为67.1%(95%CI,56–76.8%),特异性为97.5%(95%CI,94.3%-99.1%)。阳性似然比为27.2(95%CI; 11.6–74.4)。在经过PDH验证的10.5%的患者中,诊断出存在并存的机会性感染,其中多数为鸟分枝杆菌复合感染。

结论/意义

我们观察到IMMY-HUAg的高特异性但低敏感性。该测试对于开始早期抗真菌药可能是有用的,但是基于培养的方法是必要的,因为合并感染很频繁,IMMY-HUAg阴性结果不能排除PDH。

更新日期:2018-11-06
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