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

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

Research output: Contribution to journal › Research Article › peer-review

47 Scopus citations

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^® 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.

Translated title of the contribution	Evaluación de un ensayo de flujo lateral de antígeno de Histoplasma para el diagnóstico rápido de histoplasmosis diseminada progresiva en pacientes colombianos con SIDA
Original language	English (US)
Pages (from-to)	139-144
Number of pages	6
Journal	Mycoses
Volume	63
Issue number	2
DOIs	https://doi.org/10.1111/myc.13023
State	Published - Feb 1 2020

All Science Journal Classification (ASJC) codes

Dermatology
Infectious Diseases

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10.1111/myc.13023

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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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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.

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U2 - 10.1111/myc.13023

DO - 10.1111/myc.13023

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JO - Mycoses

JF - Mycoses

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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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