Multicenter Validation of Commercial Antigenuria Reagents To Diagnose Progressive Disseminated Histoplasmosis in People Living with HIV/AIDS in Two Latin American Countries
Multicenter Validation of Commercial Antigenuria Reagents To Diagnose Progressive Disseminated Histoplasmosis in People Living with HIV/AIDS in Two Latin American Countries
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DOI：
10.1128/jcm.01959-17
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发表时间：
2018-06-01
影响因子：
9.4
通讯作者：
Gomez, Beatriz L.
中科院分区：
文献类型：
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作者：
Caceres, Diego H.;Samayoa, Blanca E.;Gomez, Beatriz L.
组织胞浆菌病是艾滋病患者死亡的一个重要原因，特别是在获得抗逆转录病毒治疗和诊断检测的机会有限的国家。然而，拉丁美洲的许多播散性感染未得到诊断。在组织浆菌病流行的地区，一种简单、快速的检测荚膜组织浆菌感染的方法将大大缩短诊断和治疗时间，降低发病率和死亡率。本研究的目的是验证商业单克隆半乳甘露聚糖（HGM）酶联免疫吸附试验（immune - myologics [IMMY], Norman， OK， USA）在两个HIV/AIDS （PLHIV）患者队列中的有效性。我们分析了589人的尿液样本（466人来自危地马拉，123人来自哥伦比亚），其中546人来自艾滋病病毒感染者，43人来自非艾滋病病毒感染者。其中63人（35人来自危地马拉，28人来自哥伦比亚）通过分离荚膜胞囊菌证实了组织胞浆菌病。使用定量商业试验提供的标准曲线，灵敏度为98%(95%置信区间[Cl]， 95 ~ 100%)，特异性为97% (95% Cl, 96 ~ 99%)（截止点= 0.5 ng/ml）。半定量结果显示，使用12.5 ng/ml半乳甘露聚糖校准器计算样品的酶免疫测定指数值（EIV），灵敏度为95% (95% Cl, 89 ~ 100%)，特异性为98% (95% Cl, 96 ~ 99%)（截止值bb0 = 2.6 EIV）。这种操作相对简单的商业抗原尿试验在这两个国家都显示出高性能和可重复的结果，这表明它可以在组织胞浆菌病流行的国家的广泛临床实验室中用于检测PLHIV的进行性播散性组织胞浆菌病。
Histoplasmosis is an important cause of mortality in patients with AIDS, especially in countries with limited access to antiretroviral therapies and diagnostic tests. However, many disseminated infections in Latin America go undiagnosed. A simple, rapid method to detect Histoplasma capsulatum infection in regions where histoplasmosis is endemic would dramatically decrease the time to diagnosis and treatment, reducing morbidity and mortality. The aim of this study was to validate a commercial monoclonal Histoplasma galactomannan (HGM) enzyme-linked immunosorbent assay (Immuno-Mycologics [IMMY], Norman, OK, USA) in two cohorts of people living with HIV/AIDS (PLHIV). We analyzed urine samples from 589 people (466 from Guatemala and 123 from Colombia), including 546 from PLHIV and 43 from non-PLHIV controls. Sixty-three of these people (35 from Guatemala and 28 from Colombia) had confirmed histoplasmosis by isolation of H. capsulatum. Using the standard curve provided by the quantitative commercial test, the sensitivity was 98% (95% confidence interval [Cl], 95 to 100%) and the specificity was 97% (95% Cl, 96 to 99%) (cutoff = 0.5 ng/ml). Semiquantitative results, using a calibrator of 12.5 ng/ml of Histoplasma galactomannan to calculate an enzyme immunoassay index value (EIV) for the samples, showed a sensitivity of 95% (95% Cl, 89 to 100%) and a specificity of 98% (95% Cl, 96 to 99%) (cutoff >= 2.6 EIV). This relatively simple-toperform commercial antigenuria test showed a high performance with reproducible results in both countries, suggesting that it can be used to detect progressive disseminated histoplasmosis in PLHIV in a wide range of clinical laboratories in countries where histoplasmosis is endemic.