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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.
J Clin Microbiol 2018; 56(6)JC

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.

Authors+Show Affiliations

Medical and Experimental Mycology Group, Corporación para Investigaciones Biológicas (CIB), Medellín, Colombia. Mycotic Diseases Branch, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.Asociación de Salud Integral, Guatemala City, Guatemala. Facultad de Ciencias Químicas y Farmacia, Universidad de San Carlos de Guatemala, Guatemala City, Guatemala.Asociación de Salud Integral, Guatemala City, Guatemala. Clínica Familiar Luis Ángel García, Hospital General San Juan de Dios, Guatemala City, Guatemala.Medical and Experimental Mycology Group, Corporación para Investigaciones Biológicas (CIB), Medellín, Colombia. Hospital La María, Medellín, Colombia.Clínica Familiar Luis Ángel García, Hospital General San Juan de Dios, Guatemala City, Guatemala.Asociación de Salud Integral, Guatemala City, Guatemala. Clínica Familiar Luis Ángel García, Hospital General San Juan de Dios, Guatemala City, Guatemala.Medical and Experimental Mycology Group, Corporación para Investigaciones Biológicas (CIB), Medellín, Colombia.Mycotic Diseases Branch, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.Asociación de Salud Integral, Guatemala City, Guatemala. Clínica Familiar Luis Ángel García, Hospital General San Juan de Dios, Guatemala City, Guatemala.Medical and Experimental Mycology Group, Corporación para Investigaciones Biológicas (CIB), Medellín, Colombia beatriz.gomez@urosario.edu.co. School of Medicine and Health Sciences, Universidad del Rosario, Bogota, Colombia.

Pub Type(s)

Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, Non-P.H.S.
Research Support, U.S. Gov't, P.H.S.
Validation Studies

Language

eng

PubMed ID

29563205

Citation

Cáceres, Diego H., et al. "Multicenter Validation of Commercial Antigenuria Reagents to Diagnose Progressive Disseminated Histoplasmosis in People Living With HIV/AIDS in Two Latin American Countries." Journal of Clinical Microbiology, vol. 56, no. 6, 2018.
Cáceres DH, Samayoa BE, Medina NG, et al. Multicenter Validation of Commercial Antigenuria Reagents To Diagnose Progressive Disseminated Histoplasmosis in People Living with HIV/AIDS in Two Latin American Countries. J Clin Microbiol. 2018;56(6).
Cáceres, D. H., Samayoa, B. E., Medina, N. G., Tobón, A. M., Guzmán, B. J., Mercado, D., ... Gómez, B. L. (2018). Multicenter Validation of Commercial Antigenuria Reagents To Diagnose Progressive Disseminated Histoplasmosis in People Living with HIV/AIDS in Two Latin American Countries. Journal of Clinical Microbiology, 56(6), doi:10.1128/JCM.01959-17.
Cáceres DH, et al. Multicenter Validation of Commercial Antigenuria Reagents to Diagnose Progressive Disseminated Histoplasmosis in People Living With HIV/AIDS in Two Latin American Countries. J Clin Microbiol. 2018;56(6) PubMed PMID: 29563205.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Multicenter Validation of Commercial Antigenuria Reagents To Diagnose Progressive Disseminated Histoplasmosis in People Living with HIV/AIDS in Two Latin American Countries. AU - Cáceres,Diego H, AU - Samayoa,Blanca E, AU - Medina,Narda G, AU - Tobón,Angela M, AU - Guzmán,Brenda J, AU - Mercado,Danicela, AU - Restrepo,Angela, AU - Chiller,Tom, AU - Arathoon,Eduardo E, AU - Gómez,Beatriz L, Y1 - 2018/05/25/ PY - 2017/12/13/received PY - 2018/03/15/accepted PY - 2018/3/23/pubmed PY - 2019/4/16/medline PY - 2018/3/23/entrez KW - AIDS KW - ELISA KW - Histoplasma capsulatum KW - antigen KW - histoplasmosis JF - Journal of clinical microbiology JO - J. Clin. Microbiol. VL - 56 IS - 6 N2 - 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. SN - 1098-660X UR - https://www.unboundmedicine.com/medline/citation/29563205/Multicenter_Validation_of_Commercial_Antigenuria_Reagents_To_Diagnose_Progressive_Disseminated_Histoplasmosis_in_People_Living_with_HIV/AIDS_in_Two_Latin_American_Countries_ L2 - http://jcm.asm.org/cgi/pmidlookup?view=long&pmid=29563205 DB - PRIME DP - Unbound Medicine ER -