Evaluation of a Histoplasma antigen Lateral Flow Assay for the rapid diagnosis of progressive disseminated histoplasmosis in AIDS patients

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

Resultado de la investigación: Tipos de Contribuciónes en ConferenciaAfiche

Resumen

Objetivo: La histoplasmosis es una causa importante de mortalidad en las personas que viven con el VIH y el SIDA (PVVS), especialmente en países donde los pacientes tienen un acceso limitado a las terapias antirretrovirales y a las pruebas de diagnóstico. En las PVVS, la forma progresiva diseminada de la histoplasmosis (HDP) puede ser mortal sin tratamiento. El diagnóstico temprano es crítico para proporcionar el tratamiento adecuado, sin embargo, el diagnóstico actual por cultivo puede tomar semanas y la serología puede ser falsamente negativa en las primeras etapas de la infección o como resultado de la inmunosupresión en estos pacientes. La detección del antígeno del histoplasma en las muestras de los pacientes mejora la sensibilidad y la puntualidad del diagnóstico, pero el método actual mediante inmunoensayo enzimático debe ser realizado por personal altamente capacitado en laboratorios especializados. Recientemente, el desarrollo de la tecnología de flujo lateral ha proporcionado un método que es fácil de usar y puede realizarse en un entorno más cercano al paciente. En este estudio, se evaluó un ensayo de flujo lateral (LFA) para la detección de antígeno de Histoplasma en sueros. Métodos: Utilizando un LFA de MiraVista Diagnostics para la detección del antígeno del histoplasma, se evaluaron 47 muestras de suero: 19 de pacientes con SIDA y PDH probada en cultivo y 28 de pacientes con otras infecciones micóticas y bacterianas, así como personas sanas. Los dispositivos LFA fueron leídos por el ojo humano y el lector automatizado. Resultados: Cuando la prueba de LFA fue leída por el ojo humano, la sensibilidad era del 95% y la especificidad del 82%. Utilizando un lector automatizado, la sensibilidad fue del 89% y la especificidad del 89%. El índice de Kappa comparado con el ojo humano y el lector automatizado fue de 0,87. Las reacciones cruzadas se observaron principalmente en muestras de pacientes con diagnóstico probado de paracoccidioidomicosis. Conclusión: El MiraVista Diagnostics LFA tuvo un alto rendimiento analítico y un buen acuerdo entre el ojo humano y el lector automatizado. Esta LFA permite realizar pruebas de antígenos de histoplasma con un mínimo de equipo de laboratorio y requisitos de infraestructura. Basado en estos resultados, este nuevo método es una opción viable para el diagnóstico rápido de la PDH. LFA proporciona resultados altamente sensibles en <1 hora, siendo más rápido y más sensible a la PDH que otros ensayos inmunológicos, como ELISA (de tres a cinco horas; >90% de sensibilidad), inmunodifusión y fijación del complemento (dos días; ∼% de sensibilidad), y pruebas microbiológicas convencionales, incluyendo examen histopatológico (uno a dos días; ∼% de sensibilidad) y cultivo (dos a cuatro semanas; ∼% de sensibilidad). El diagnóstico oportuno de la HDP podría tener un impacto en la salud pública al iniciar un tratamiento temprano, reduciendo así la mortalidad.
Idioma originalEnglish (US)
PáginasS1-S159
Número de páginas158
DOI
EstadoPublished - jun 5 2018
Evento20th Congress of the International Society for Human and Animal Mycology - Amsterdam
Duración: jun 30 2018jul 4 2018
https://www.isham2018.org/en/Home_10_6_12.html

Conference

Conference20th Congress of the International Society for Human and Animal Mycology
Título abreviado20th Congress ISHAM
PaísNetherlands
CiudadAmsterdam
Período6/30/187/4/18
Dirección de internet

Citar esto

Gómez, B. L. (2018). Evaluation of a Histoplasma antigen Lateral Flow Assay for the rapid diagnosis of progressive disseminated histoplasmosis in AIDS patients. S1-S159. Sesión de cárteles presentada en 20th Congress of the International Society for Human and Animal Mycology, Amsterdam, . https://doi.org/10.1093/mmy/myy036
Gómez, Beatriz L. / Evaluation of a Histoplasma antigen Lateral Flow Assay for the rapid diagnosis of progressive disseminated histoplasmosis in AIDS patients. Sesión de cárteles presentada en 20th Congress of the International Society for Human and Animal Mycology, Amsterdam, .158 p.
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abstract = "Objective: Histoplasmosis is an important cause of mortality in persons living with HIV and AIDS (PLWHA), especially in countries where patients have limited access to antiretroviral therapies and diagnostic testing. In PLWHA, the progressive disseminated form of histoplasmosis (PDH) can be fatal without treatment. Early diagnosis is critical for providing proper treatment, however, current diagnosis by culture can take weeks and serology may be falsely negative early in infection or as a result of immunosuppression in these patients. Detection of Histoplasma antigen in patient specimens improves sensitivity and timeliness of diagnosis, but the current method by enzyme immunoassay must be performed by highly trained personnel in specialty laboratories. Recently, the development of the lateral flow technology has provided a method that is simple to use and can be performed in a setting closer to the patient. In this study, a lateral flow assay (LFA) was evaluated for the detection of Histoplasma antigen in sera. Methods: Using a MiraVista Diagnostics LFA for detection of Histoplasma antigen, we evaluated 47 serum samples: 19 from patients with AIDS and culture-proven PDH and 28 from patients with other fungal and bacterial infections, as well as healthy people. LFA devices were read by human eye and automated reader. Results: When the LFA test was read by human eye, sensitivity was 95{\%} and specificity was 82{\%}. Using an automated reader, sensitivity was 89{\%} and specificity was 89{\%}. The Kappa index compared human eye and automated reader was 0.87. Cross-reactions were observed principally in samples from patients with proven diagnosis of paracoccidioidomycosis. Conclusion: The MiraVista Diagnostics LFA had high analytical performance and good agreement between human eye and automated reader. This LFA allows Histoplasma antigen testing with minimal laboratory equipment and infrastructure requirements. Based on these results, this new method is a viable option for rapid diagnosis of PDH. LFA provides highly sensitive results in <1 hour, being faster and more sensitive for PDH than other immunological assays, such as ELISA (three to five hours; >90{\%} sensitivity), immunodiffusion and complement fixation (two days; ∼65{\%} sensitivity), and conventional microbiological tests, including histopathologic examination (one to two days; ∼75{\%} sensitivity) and culture (two to four weeks; ∼80{\%} sensitivity). Prompt diagnosis of PDH could impact public health by initiating early treatment thereby reducing mortality.",
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Evaluation of a Histoplasma antigen Lateral Flow Assay for the rapid diagnosis of progressive disseminated histoplasmosis in AIDS patients. / Gómez, Beatriz L.

2018. S1-S159 Sesión de cárteles presentada en 20th Congress of the International Society for Human and Animal Mycology, Amsterdam, .

Resultado de la investigación: Tipos de Contribuciónes en ConferenciaAfiche

TY - CONF

T1 - Evaluation of a Histoplasma antigen Lateral Flow Assay for the rapid diagnosis of progressive disseminated histoplasmosis in AIDS patients

AU - Gómez, Beatriz L.

PY - 2018/6/5

Y1 - 2018/6/5

N2 - Objective: Histoplasmosis is an important cause of mortality in persons living with HIV and AIDS (PLWHA), especially in countries where patients have limited access to antiretroviral therapies and diagnostic testing. In PLWHA, the progressive disseminated form of histoplasmosis (PDH) can be fatal without treatment. Early diagnosis is critical for providing proper treatment, however, current diagnosis by culture can take weeks and serology may be falsely negative early in infection or as a result of immunosuppression in these patients. Detection of Histoplasma antigen in patient specimens improves sensitivity and timeliness of diagnosis, but the current method by enzyme immunoassay must be performed by highly trained personnel in specialty laboratories. Recently, the development of the lateral flow technology has provided a method that is simple to use and can be performed in a setting closer to the patient. In this study, a lateral flow assay (LFA) was evaluated for the detection of Histoplasma antigen in sera. Methods: Using a MiraVista Diagnostics LFA for detection of Histoplasma antigen, we evaluated 47 serum samples: 19 from patients with AIDS and culture-proven PDH and 28 from patients with other fungal and bacterial infections, as well as healthy people. LFA devices were read by human eye and automated reader. Results: When the LFA test was read by human eye, sensitivity was 95% and specificity was 82%. Using an automated reader, sensitivity was 89% and specificity was 89%. The Kappa index compared human eye and automated reader was 0.87. Cross-reactions were observed principally in samples from patients with proven diagnosis of paracoccidioidomycosis. Conclusion: The MiraVista Diagnostics LFA had high analytical performance and good agreement between human eye and automated reader. This LFA allows Histoplasma antigen testing with minimal laboratory equipment and infrastructure requirements. Based on these results, this new method is a viable option for rapid diagnosis of PDH. LFA provides highly sensitive results in <1 hour, being faster and more sensitive for PDH than other immunological assays, such as ELISA (three to five hours; >90% sensitivity), immunodiffusion and complement fixation (two days; ∼65% sensitivity), and conventional microbiological tests, including histopathologic examination (one to two days; ∼75% sensitivity) and culture (two to four weeks; ∼80% sensitivity). Prompt diagnosis of PDH could impact public health by initiating early treatment thereby reducing mortality.

AB - Objective: Histoplasmosis is an important cause of mortality in persons living with HIV and AIDS (PLWHA), especially in countries where patients have limited access to antiretroviral therapies and diagnostic testing. In PLWHA, the progressive disseminated form of histoplasmosis (PDH) can be fatal without treatment. Early diagnosis is critical for providing proper treatment, however, current diagnosis by culture can take weeks and serology may be falsely negative early in infection or as a result of immunosuppression in these patients. Detection of Histoplasma antigen in patient specimens improves sensitivity and timeliness of diagnosis, but the current method by enzyme immunoassay must be performed by highly trained personnel in specialty laboratories. Recently, the development of the lateral flow technology has provided a method that is simple to use and can be performed in a setting closer to the patient. In this study, a lateral flow assay (LFA) was evaluated for the detection of Histoplasma antigen in sera. Methods: Using a MiraVista Diagnostics LFA for detection of Histoplasma antigen, we evaluated 47 serum samples: 19 from patients with AIDS and culture-proven PDH and 28 from patients with other fungal and bacterial infections, as well as healthy people. LFA devices were read by human eye and automated reader. Results: When the LFA test was read by human eye, sensitivity was 95% and specificity was 82%. Using an automated reader, sensitivity was 89% and specificity was 89%. The Kappa index compared human eye and automated reader was 0.87. Cross-reactions were observed principally in samples from patients with proven diagnosis of paracoccidioidomycosis. Conclusion: The MiraVista Diagnostics LFA had high analytical performance and good agreement between human eye and automated reader. This LFA allows Histoplasma antigen testing with minimal laboratory equipment and infrastructure requirements. Based on these results, this new method is a viable option for rapid diagnosis of PDH. LFA provides highly sensitive results in <1 hour, being faster and more sensitive for PDH than other immunological assays, such as ELISA (three to five hours; >90% sensitivity), immunodiffusion and complement fixation (two days; ∼65% sensitivity), and conventional microbiological tests, including histopathologic examination (one to two days; ∼75% sensitivity) and culture (two to four weeks; ∼80% sensitivity). Prompt diagnosis of PDH could impact public health by initiating early treatment thereby reducing mortality.

U2 - 10.1093/mmy/myy036

DO - 10.1093/mmy/myy036

M3 - Poster

SP - S1-S159

ER -

Gómez BL. Evaluation of a Histoplasma antigen Lateral Flow Assay for the rapid diagnosis of progressive disseminated histoplasmosis in AIDS patients. 2018. Sesión de cárteles presentada en 20th Congress of the International Society for Human and Animal Mycology, Amsterdam, . https://doi.org/10.1093/mmy/myy036