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

Diego H Cáceres; Blanca E Samayoa; Narda G Medina; Angela M Tobón; Brenda J Guzmán; Danicela Mercado; Angela Restrepo; Tom Chiller; Eduardo E Arathoon; Beatriz L Gómez

doi:10.1128/JCM.01959-17

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

Diego H Cáceres, Blanca E Samayoa, Narda G Medina, Angela M Tobón, Brenda J Guzmán, Danicela Mercado, Angela Restrepo, Tom Chiller, Eduardo E Arathoon, Beatriz L Gómez

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Resumen

La histoplasmosis es una causa importante de mortalidad en pacientes con SIDA, especialmente en países con acceso limitado a terapias antirretrovirales y pruebas de diagnóstico. Sin embargo, muchas de las infecciones diseminadas en América Latina no son diagnosticadas. Un método simple y rápido para detectar la infección por Histoplasma capsulatum en regiones donde la histoplasmosis es endémica disminuiría drásticamente el tiempo de diagnóstico y tratamiento, reduciendo la morbilidad y la mortalidad. El objetivo de este estudio fue validar un ensayo comercial monoclonal de Histoplasma galactomanano (HGM) inmunoenzimático (Immuno-Mycologics[IMMY], Norman, OK, USA) en dos cohortes de personas que viven con VIH/SIDA (PVVIH). Analizamos muestras de orina de 589 personas (466 de Guatemala y 123 de Colombia), incluyendo 546 de PVVS y 43 de controles no relacionados con PVVS. Sesenta y tres de estas personas (35 de Guatemala y 28 de Colombia) habían confirmado la histoplasmosis mediante el aislamiento de H. capsulatum. Utilizando la curva estándar proporcionada por la prueba comercial cuantitativa, la sensibilidad fue del 98% (intervalo de confianza[IC] del 95%, 95 a 100%) y la especificidad fue del 97% (IC del 95%, 96 a 99%) (corte = 0,5 ng/ml). Los resultados semicuantitativos, utilizando un calibrador de 12,5 ng/ml de Histoplasma galactomannan para calcular un valor de índice de inmunoensayo enzimático (EIV) para las muestras, mostraron una sensibilidad del 95% (IC del 95%: 89 a 100%) y una especificidad del 98% (IC del 95%: 96 a 99%) (valor de corte ≥ 2,6 EIV). Esta prueba de antigenuria comercial relativamente fácil de realizar mostró un alto rendimiento con resultados reproducibles en ambos países, lo que sugiere que puede utilizarse para detectar la histoplasmosis diseminada progresiva en las PVVIH en una amplia gama de laboratorios clínicos en países donde la histoplasmosis es endémica.

Idioma original	Inglés estadounidense
Publicación	Journal of Clinical Microbiology
Volumen	56
N.º	6
DOI	https://doi.org/10.1128/JCM.01959-17
Estado	Publicada - jun. 2018

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Cáceres, D. H., Samayoa, B. E., Medina, N. G., Tobón, A. M., Guzmán, B. J., Mercado, D., Restrepo, A., Chiller, T., Arathoon, E. E., & 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). https://doi.org/10.1128/JCM.01959-17

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

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 endemic regions would dramatically decrease time to diagnosis and treatment, reducing morbidity and mortality. The aim of this study was to validate a commercial monoclonal Histoplasma galactomannan (HGM) ELISA (Immuno-Mycologics [IMMY], Norman, Oklahoma, 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, sensitivity was 98% (95% CI, 95-100) and specificity was 97% (95% CI, 96-99) (cutoff=0.5 ng/mL). Semi-quantitative results, using a calibrator of 12.5 ng/mL of Histoplasma galactomannan to calculate an EIA Index Value (EIV) of the samples, showed a sensitivity of 95% (95% CI, 89-100%) and specificity of 98% (95% CI, 96-99%) (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 used to detect progressive disseminated histoplasmosis in PLHIV in a wide range of clinical laboratories in countries where histoplasmosis is endemic.",

author = "C{\'a}ceres, {Diego H} and Samayoa, {Blanca E} and Medina, {Narda G} and Tob{\'o}n, {Angela M} and Guzm{\'a}n, {Brenda J} and Danicela Mercado and Angela Restrepo and Tom Chiller and Arathoon, {Eduardo E} and G{\'o}mez, {Beatriz L}",

note = "Copyright {\textcopyright} 2018 American Society for Microbiology.",

year = "2018",

month = jun,

doi = "10.1128/JCM.01959-17",

language = "English (US)",

volume = "56",

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Cáceres, DH, Samayoa, BE, Medina, NG, Tobón, AM, Guzmán, BJ, Mercado, D, Restrepo, A, Chiller, T, Arathoon, EE & Gómez, BL 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, vol. 56, n.º 6. https://doi.org/10.1128/JCM.01959-17

Multicenter Validation of Commercial Antigenuria Reagents To Diagnose Progressive Disseminated Histoplasmosis in People Living with HIV/AIDS in Two Latin American Countries. / Cáceres, Diego H; Samayoa, Blanca E; Medina, Narda G et al.
En: Journal of Clinical Microbiology, Vol. 56, N.º 6, 06.2018.

Producción científica: Contribución a una revista › Artículo de Investigación › revisión exhaustiva

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

PY - 2018/6

Y1 - 2018/6

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 endemic regions would dramatically decrease time to diagnosis and treatment, reducing morbidity and mortality. The aim of this study was to validate a commercial monoclonal Histoplasma galactomannan (HGM) ELISA (Immuno-Mycologics [IMMY], Norman, Oklahoma, 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, sensitivity was 98% (95% CI, 95-100) and specificity was 97% (95% CI, 96-99) (cutoff=0.5 ng/mL). Semi-quantitative results, using a calibrator of 12.5 ng/mL of Histoplasma galactomannan to calculate an EIA Index Value (EIV) of the samples, showed a sensitivity of 95% (95% CI, 89-100%) and specificity of 98% (95% CI, 96-99%) (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 used to detect progressive disseminated histoplasmosis in PLHIV in a wide range of clinical laboratories in countries where histoplasmosis is endemic.

AB - 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 endemic regions would dramatically decrease time to diagnosis and treatment, reducing morbidity and mortality. The aim of this study was to validate a commercial monoclonal Histoplasma galactomannan (HGM) ELISA (Immuno-Mycologics [IMMY], Norman, Oklahoma, 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, sensitivity was 98% (95% CI, 95-100) and specificity was 97% (95% CI, 96-99) (cutoff=0.5 ng/mL). Semi-quantitative results, using a calibrator of 12.5 ng/mL of Histoplasma galactomannan to calculate an EIA Index Value (EIV) of the samples, showed a sensitivity of 95% (95% CI, 89-100%) and specificity of 98% (95% CI, 96-99%) (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 used to detect progressive disseminated histoplasmosis in PLHIV in a wide range of clinical laboratories in countries where histoplasmosis is endemic.

U2 - 10.1128/JCM.01959-17

DO - 10.1128/JCM.01959-17

M3 - Research Article

C2 - 29563205

SN - 0095-1137

VL - 56

JO - Journal of Clinical Microbiology

JF - Journal of Clinical Microbiology

IS - 6

ER -

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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