Multicenter Validation of Commercial Antigenuria Reagents To Diagnose Progressive Disseminated Histoplasmosis in People Living with HIV/AIDS in Two Latin American Countries

Author:

Cáceres Diego H.12ORCID,Samayoa Blanca E.34,Medina Narda G.35,Tobón Angela M.16,Guzmán Brenda J.5,Mercado Danicela35,Restrepo Angela1,Chiller Tom2,Arathoon Eduardo E.35,Gómez Beatriz L.17ORCID

Affiliation:

1. Medical and Experimental Mycology Group, Corporación para Investigaciones Biológicas (CIB), Medellín, Colombia

2. Mycotic Diseases Branch, Centers for Disease Control and Prevention, Atlanta, Georgia, USA

3. Asociación de Salud Integral, Guatemala City, Guatemala

4. Facultad de Ciencias Químicas y Farmacia, Universidad de San Carlos de Guatemala, Guatemala City, Guatemala

5. Clínica Familiar Luis Ángel García, Hospital General San Juan de Dios, Guatemala City, Guatemala

6. Hospital La María, Medellín, Colombia

7. School of Medicine and Health Sciences, Universidad del Rosario, Bogota, Colombia

Abstract

ABSTRACT 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 [CI], 95 to 100%) and the specificity was 97% (95% CI, 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% CI, 89 to 100%) and a specificity of 98% (95% CI, 96 to 99%) (cutoff ≥ 2.6 EIV). This relatively simple-to-perform 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.

Publisher

American Society for Microbiology

Subject

Microbiology (medical)

Reference34 articles.

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5. Implementation of a Training Course Increased the Diagnosis of Histoplasmosis in Colombia

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