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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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Autores
Cáceres, Diego H.
Samayoa, Blanca E.
Medina, Narda G.
Tobón, Angela M.
Guzmán, Brenda J.
Mercado, Danicela
Restrepo, Angela
Chiller, Tom
Arathoon, Eduardo E.
Gómez, Beatriz L.
Fecha
2018
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American Society for Microbiology
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Resumen
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. Copyright © 2018 American Society for Microbiology. All Rights Reserved.
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Keywords
Galactomannan , Fungus antigen , Mannan , Acquired immune deficiency syndrome , Article , Cohort analysis , Colombia , Controlled study , Diagnostic accuracy , Diagnostic test accuracy study , Diagnostic value , Enzyme linked immunosorbent assay , Fungal detection , Fungus isolation , Guatemala , Histoplasmosis , Human , Human immunodeficiency virus infection , Major clinical study , Nonhuman , Predictive value , Priority journal , Progressive disseminated histoplasmosis , Reproducibility , Retrospective study , Sensitivity and specificity , South and central america , Urine sampling , Aids related complex , Clinical trial , Complication , Diagnostic kit , Enzyme linked immunosorbent assay , Hispanic , Histoplasma , Histoplasmosis , Immunology , Isolation and purification , Microbiology , Mixed infection , Multicenter study , Urine , Validation study , Virology , Aids-related opportunistic infections , Antigens , Cohort studies , Coinfection , Colombia , Enzyme-linked immunosorbent assay , Guatemala , Hispanic americans , Histoplasma , Histoplasmosis , Mannans , Reagent kits , Reproducibility of results , Retrospective studies , Sensitivity and specificity , Aids , Antigen , Elisa , Histoplasma capsulatum , Histoplasmosis
