Evaluation of a Histoplasma antigen lateral flow assay for the rapid diagnosis of progressive disseminated histoplasmosis in Colombian patients with AIDS

Diego H. Cáceres; Beatriz L. Gómez; Angela M. Tobón; Tom M. Chiller; Mark D. Lindsley

doi:10.1111/myc.13023

Evaluation of a Histoplasma antigen lateral flow assay for the rapid diagnosis of progressive disseminated histoplasmosis in Colombian patients with AIDS

Título traducido de la contribución: Evaluación de un ensayo de flujo lateral de antígeno de Histoplasma para el diagnóstico rápido de histoplasmosis diseminada progresiva en pacientes colombianos con SIDA

Diego H. Cáceres
, Beatriz L. Gómez
, Angela M. Tobón
, Tom M. Chiller
, Mark D. Lindsley

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

60 Citas (Scopus)

Resumen

Antecedentes: La histoplasmosis diseminada progresiva (HDP) es una causa importante de mortalidad en personas que viven con VIH (PVVIH), especialmente en países donde los pacientes tienen acceso limitado a terapias antirretrovirales y pruebas diagnósticas. Objetivo: Se evaluó un ensayo de flujo lateral (LFA) para detectar el antígeno de Histoplasma capsulatum en suero desarrollado por MiraVista®. Métodos: Se analizaron 75 muestras de suero: 24 de PVVIH y HDP comprobada por cultivo y 51 de PVVIH con otras infecciones fúngicas y bacterianas, así como personas sin VIH. Los dispositivos LFA se leyeron manualmente (a simple vista) y con un lector automático. Resultados: Cuando el LFA se leyó manualmente, la sensibilidad fue del 96% y la especificidad fue del 90%. Cuando se utilizó un lector automático, la sensibilidad fue del 92% y la especificidad fue del 94%. El índice Kappa comparando el lector manual y el automático fue de 0,90. Se observaron reacciones cruzadas principalmente en muestras de pacientes con diagnóstico comprobado de paracoccidioidomicosis. Conclusiones: El analizador de antígenos de histoplasma MiraVista® Diagnostics presentó un alto rendimiento analítico y una buena concordancia entre el lector manual y el automático. Este analizador de antígenos de histoplasma permite realizar pruebas de antígenos de histoplasma con requisitos mínimos de infraestructura y equipo de laboratorio.

Título traducido de la contribución	Evaluación de un ensayo de flujo lateral de antígeno de Histoplasma para el diagnóstico rápido de histoplasmosis diseminada progresiva en pacientes colombianos con SIDA
Idioma original	Inglés estadounidense
Páginas (desde-hasta)	139-144
Número de páginas	6
Publicación	Mycoses
Volumen	63
N.º	2
DOI	https://doi.org/10.1111/myc.13023
Estado	Publicada - feb. 1 2020

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ODS 3: Salud y bienestar

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Dermatología
Enfermedades infecciosas

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@article{e6068f24251b4c31837f0a9e6db54f38,

title = "Evaluation of a Histoplasma antigen lateral flow assay for the rapid diagnosis of progressive disseminated histoplasmosis in Colombian patients with AIDS",

abstract = "Background: Progressive disseminated histoplasmosis (PDH) is an important cause of mortality in persons living with HIV (PLHIV), especially in countries where patients have limited access to antiretroviral therapies and diagnostic testing. Objective: A lateral flow assay (LFA) to detect Histoplasma capsulatum antigen in serum developed by MiraVista{\textregistered} was evaluated. Methods: We tested 75 serum samples: 24 from PLHIV and culture-proven PDH and 51 from PLHIV with other fungal and bacterial infections as well as people without HIV. LFA devices were read manually (read by eye) and by an automated reader. Results: When the LFA was read manually, sensitivity was 96\% and specificity was 90\%. When an automated reader was used, sensitivity was 92\% and specificity was 94\%. The Kappa index comparing manual and automated reader was 0.90. Cross-reactions were observed principally in samples from patients with proven diagnosis of paracoccidioidomycosis. Conclusions: The MiraVista{\textregistered} Diagnostics Histoplasma antigen LFA had high analytical performance and good agreement between manual and automated reader. This LFA allows Histoplasma antigen testing with minimal laboratory equipment and infrastructure requirements.",

author = "C{\'a}ceres, \{Diego H.\} and G{\'o}mez, \{Beatriz L.\} and Tob{\'o}n, \{Angela M.\} and Chiller, \{Tom M.\} and Lindsley, \{Mark D.\}",

note = "Funding Information: The work presented here was supported in part by the Global Disease Detection Program, CDC, Atlanta, GA, USA, by the Corporaci{\'o}n para Investigaciones Biol{\'o}gicas (CIB), Medellin, Colombia, by Colciencias, Bogot{\'a}, Colombia via the Program for Young Investigators and Innovators, by the Fondo de Investigaciones de la Universidad del Rosario (FIUR), Bogota, Colombia, and by the Oak Ridge Institute for Science and Education (ORISE), Oak Ridge, TN, USA. The authors report no conflicts of interest. Reagents were provided by MiraVista {\textregistered} Diagnostics (IN, USA). The findings and conclusions in this article are those of the authors and do not necessarily represent the official position of the CDC. Publisher Copyright: {\textcopyright} 2019 Blackwell Verlag GmbH Copyright: Copyright 2020 Elsevier B.V., All rights reserved.",

year = "2020",

month = feb,

day = "1",

doi = "10.1111/myc.13023",

language = "English (US)",

volume = "63",

pages = "139--144",

journal = "Mycoses",

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}

Evaluation of a Histoplasma antigen lateral flow assay for the rapid diagnosis of progressive disseminated histoplasmosis in Colombian patients with AIDS. / Cáceres, Diego H.; Gómez, Beatriz L.; Tobón, Angela M. et al.
En: Mycoses, Vol. 63, N.º 2, 01.02.2020, p. 139-144.

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

TY - JOUR

T1 - Evaluation of a Histoplasma antigen lateral flow assay for the rapid diagnosis of progressive disseminated histoplasmosis in Colombian patients with AIDS

AU - Cáceres, Diego H.

AU - Gómez, Beatriz L.

AU - Tobón, Angela M.

AU - Chiller, Tom M.

AU - Lindsley, Mark D.

N1 - Funding Information: The work presented here was supported in part by the Global Disease Detection Program, CDC, Atlanta, GA, USA, by the Corporación para Investigaciones Biológicas (CIB), Medellin, Colombia, by Colciencias, Bogotá, Colombia via the Program for Young Investigators and Innovators, by the Fondo de Investigaciones de la Universidad del Rosario (FIUR), Bogota, Colombia, and by the Oak Ridge Institute for Science and Education (ORISE), Oak Ridge, TN, USA. The authors report no conflicts of interest. Reagents were provided by MiraVista ® Diagnostics (IN, USA). The findings and conclusions in this article are those of the authors and do not necessarily represent the official position of the CDC. Publisher Copyright: © 2019 Blackwell Verlag GmbH Copyright: Copyright 2020 Elsevier B.V., All rights reserved.

PY - 2020/2/1

Y1 - 2020/2/1

N2 - Background: Progressive disseminated histoplasmosis (PDH) is an important cause of mortality in persons living with HIV (PLHIV), especially in countries where patients have limited access to antiretroviral therapies and diagnostic testing. Objective: A lateral flow assay (LFA) to detect Histoplasma capsulatum antigen in serum developed by MiraVista® was evaluated. Methods: We tested 75 serum samples: 24 from PLHIV and culture-proven PDH and 51 from PLHIV with other fungal and bacterial infections as well as people without HIV. LFA devices were read manually (read by eye) and by an automated reader. Results: When the LFA was read manually, sensitivity was 96% and specificity was 90%. When an automated reader was used, sensitivity was 92% and specificity was 94%. The Kappa index comparing manual and automated reader was 0.90. Cross-reactions were observed principally in samples from patients with proven diagnosis of paracoccidioidomycosis. Conclusions: The MiraVista® Diagnostics Histoplasma antigen LFA had high analytical performance and good agreement between manual and automated reader. This LFA allows Histoplasma antigen testing with minimal laboratory equipment and infrastructure requirements.

AB - Background: Progressive disseminated histoplasmosis (PDH) is an important cause of mortality in persons living with HIV (PLHIV), especially in countries where patients have limited access to antiretroviral therapies and diagnostic testing. Objective: A lateral flow assay (LFA) to detect Histoplasma capsulatum antigen in serum developed by MiraVista® was evaluated. Methods: We tested 75 serum samples: 24 from PLHIV and culture-proven PDH and 51 from PLHIV with other fungal and bacterial infections as well as people without HIV. LFA devices were read manually (read by eye) and by an automated reader. Results: When the LFA was read manually, sensitivity was 96% and specificity was 90%. When an automated reader was used, sensitivity was 92% and specificity was 94%. The Kappa index comparing manual and automated reader was 0.90. Cross-reactions were observed principally in samples from patients with proven diagnosis of paracoccidioidomycosis. Conclusions: The MiraVista® Diagnostics Histoplasma antigen LFA had high analytical performance and good agreement between manual and automated reader. This LFA allows Histoplasma antigen testing with minimal laboratory equipment and infrastructure requirements.

UR - https://www.scopus.com/pages/publications/85075746317

UR - https://www.scopus.com/pages/publications/85075746317#tab=citedBy

U2 - 10.1111/myc.13023

DO - 10.1111/myc.13023

M3 - Research Article

C2 - 31625627

AN - SCOPUS:85075746317

SN - 0933-7407

VL - 63

SP - 139

EP - 144

JO - Mycoses

JF - Mycoses

IS - 2

ER -

Evaluation of a Histoplasma antigen lateral flow assay for the rapid diagnosis of progressive disseminated histoplasmosis in Colombian patients with AIDS

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