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Diagnostic accuracy cohort study and clinical value of the Histoplasma urine antigen (ALPHA Histoplasma EIA) for disseminated histoplasmosis among HIV infected patients: A multicenter study.
PLoS Negl Trop Dis 2018; 12(11):e0006872PN

Abstract

BACKGROUND

The Histoplasma urine antigen (HUAg) is the preferred method to diagnose progressive disseminated histoplasmosis (PDH) in HIV patients. In 2007, IMMY ALPHA Histoplasma EIA was approved for clinical for on-site use, and therefore useful for regions outside the United States. However, ALPHA-HUAg is considered inferior to the MVista-HUAg which is only available on referral. We aim to evaluate the diagnostic accuracy of ALPHA-HUAg.

METHODOLOGY/PRINCIPAL FINDINGS

We conducted a multicenter, prospective, diagnostic test study in two secondary and eight tertiary-care facilities in Mexico. We included HIV patient with PDH suspicion and evaluated ALPHA-HUAg diagnostic accuracy using as reference standard the Histoplasma capsulatum growth on blood, bone marrow, and tissue cultures or compatible histopathologic exam (PDH-proven). We evaluated the results of 288 patients, 29.5% (85/288; 95% confidence interval [CI], 24.3-35.1) had PDH. The sensitivity of ALPHA-HUAg was 67.1% (95% CI, 56-76.8%) and the specificity was 97.5% (95% CI, 94.3%-99.1%). The positive likelihood ratio was 27.2 (95% CI; 11.6-74.4). In 10.5% of the PDH-proven patients, a co-existing opportunistic infection was diagnosed, mostly disseminated Mycobacterium avium complex infection.

CONCLUSIONS/SIGNIFICANCE

We observed a high specificity but low sensitivity of IMMY-HUAg. The test may be useful to start early antifungals, but a culture-based approach is necessary since co-infections are frequent and a negative IMMY-HUAg result does not rule out PDH.

Authors+Show Affiliations

Department of Infectious Diseases, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Tlalpan, Mexico City, Mexico.Department of Infectious Diseases, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Tlalpan, Mexico City, Mexico.Department of Infectious Diseases, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Tlalpan, Mexico City, Mexico.Centro de Investigación en Enfermedades Infecciosas, Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas, Tlalpan, Mexico City, Mexico.HIV Unit, Hospital Civil de Guadalajara "Fray Antonio Alcalde", Guadalajara, Jalisco, Mexico.Department of Internal Medicine, Hospital Central Dr. Ignacio Morones Prieto, San Luis Potosí, San Luis Potosí, Mexico.Adult Infectious Diseases Department, Hospital de Infectología del Centro Médico Nacional "La Raza", Instituto Mexicano del Seguro Social, Atzcapotzalco, Mexico City, Mexico.Department of Infectious Diseases, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Tlalpan, Mexico City, Mexico.Department of Infectious Diseases, Hospital Regional de Alta Especialidad de Oaxaca, HRAEO, San Bartolo Coyotepec, Oaxaca, Mexico.Department of Pathology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubiran, Tlalpan, Mexico City, Mexico.Intensive Care Unit, Department of Internal Medicine, Hospital "Dr. Juan Graham Casasus", Villahermosa, Tabasco, Mexico.Adult Infectious Diseases Department, Hospital de Infectología del Centro Médico Nacional "La Raza", Instituto Mexicano del Seguro Social, Atzcapotzalco, Mexico City, Mexico.HIV Unit, Hospital Civil de Guadalajara "Fray Antonio Alcalde", Guadalajara, Jalisco, Mexico.Area of Infectious Diseases, Department of Internal Medicine, Hospital General de Puebla "Dr. Eduardo Vazquez Navarro", Puebla, Puebla, Mexico.Centro de Investigación en Enfermedades Infecciosas, Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas, Tlalpan, Mexico City, Mexico.Department of Internal Medicine, Hospital de Alta Especialidad de Veracruz, Veracruz, Veracruz, Mexico.Department of Internal Medicine, Hospital Central Dr. Ignacio Morones Prieto, San Luis Potosí, San Luis Potosí, Mexico.HIV Unit, Hospital Civil de Guadalajara "Fray Antonio Alcalde", Guadalajara, Jalisco, Mexico.Infectious Diseases Department, Hospital General Dr. Manuel Gea González, Tlalpan, Mexico City, Mexico.Department of Infectious Diseases, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Tlalpan, Mexico City, Mexico.Department of Infectious Diseases, Hospital Regional de Alta Especialidad de Oaxaca, HRAEO, San Bartolo Coyotepec, Oaxaca, Mexico.Department of Pathology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubiran, Tlalpan, Mexico City, Mexico.Centro de Investigación en Enfermedades Infecciosas, Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas, Tlalpan, Mexico City, Mexico.Infectious Diseases Department, Hospital General Dr. Manuel Gea González, Tlalpan, Mexico City, Mexico.Intensive Care Unit, Department of Internal Medicine, Hospital "Dr. Juan Graham Casasus", Villahermosa, Tabasco, Mexico.Department of Infectious Diseases, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Tlalpan, Mexico City, Mexico.Department of Infectious Diseases, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Tlalpan, Mexico City, Mexico.Department of Medicine, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Tlalpan, Mexico City, Mexico.Department of Infectious Diseases, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Tlalpan, Mexico City, Mexico.

Pub Type(s)

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

Language

eng

PubMed ID

30395572

Citation

Torres-González, Pedro, et al. "Diagnostic Accuracy Cohort Study and Clinical Value of the Histoplasma Urine Antigen (ALPHA Histoplasma EIA) for Disseminated Histoplasmosis Among HIV Infected Patients: a Multicenter Study." PLoS Neglected Tropical Diseases, vol. 12, no. 11, 2018, pp. e0006872.
Torres-González P, Niembro-Ortega MD, Martínez-Gamboa A, et al. Diagnostic accuracy cohort study and clinical value of the Histoplasma urine antigen (ALPHA Histoplasma EIA) for disseminated histoplasmosis among HIV infected patients: A multicenter study. PLoS Negl Trop Dis. 2018;12(11):e0006872.
Torres-González, P., Niembro-Ortega, M. D., Martínez-Gamboa, A., Ahumada-Topete, V. H., Andrade-Villanueva, J., Araujo-Meléndez, J., ... Ponce de León, A. (2018). Diagnostic accuracy cohort study and clinical value of the Histoplasma urine antigen (ALPHA Histoplasma EIA) for disseminated histoplasmosis among HIV infected patients: A multicenter study. PLoS Neglected Tropical Diseases, 12(11), pp. e0006872. doi:10.1371/journal.pntd.0006872.
Torres-González P, et al. Diagnostic Accuracy Cohort Study and Clinical Value of the Histoplasma Urine Antigen (ALPHA Histoplasma EIA) for Disseminated Histoplasmosis Among HIV Infected Patients: a Multicenter Study. PLoS Negl Trop Dis. 2018;12(11):e0006872. PubMed PMID: 30395572.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Diagnostic accuracy cohort study and clinical value of the Histoplasma urine antigen (ALPHA Histoplasma EIA) for disseminated histoplasmosis among HIV infected patients: A multicenter study. AU - Torres-González,Pedro, AU - Niembro-Ortega,María Dolores, AU - Martínez-Gamboa,Areli, AU - Ahumada-Topete,Víctor Hugo, AU - Andrade-Villanueva,Jaime, AU - Araujo-Meléndez,Javier, AU - Chaparro-Sánchez,Alberto, AU - Crabtree-Ramírez,Brenda, AU - Cruz-Martínez,Sofia, AU - Gamboa-Domínguez,Armando, AU - Flores-Barrientos,Oscar I, AU - Gaytán-Martínez,Jesús Enrique, AU - González-Hernández,Luz Alicia, AU - Hernández-León,Christian, AU - Lozano-Fernandez,Víctor Hugo, AU - Manríquez-Reyes,Marisol, AU - Magaña-Aquino,Martin, AU - Martínez-Ayala,Pedro, AU - Ramírez-Hinojosa,Juan Pablo, AU - Rangel-Cordero,Andrea, AU - Rivera-Martínez,Norma Erendira, AU - Reyes-Gutiérrez,Edgardo, AU - Reyes-Terán,Gustavo, AU - Rodríguez-Zulueta,Patricia, AU - Ruíz-Quiñones,Jesús, AU - Santiago-Cruz,Janeth, AU - Velázquez-Zavala,Nancy Guadalupe, AU - Sifuentes-Osornio,José, AU - Ponce de León,Alfredo, Y1 - 2018/11/05/ PY - 2018/04/04/received PY - 2018/09/25/accepted PY - 2018/11/15/revised PY - 2018/11/6/pubmed PY - 2019/1/22/medline PY - 2018/11/6/entrez SP - e0006872 EP - e0006872 JF - PLoS neglected tropical diseases JO - PLoS Negl Trop Dis VL - 12 IS - 11 N2 - BACKGROUND: The Histoplasma urine antigen (HUAg) is the preferred method to diagnose progressive disseminated histoplasmosis (PDH) in HIV patients. In 2007, IMMY ALPHA Histoplasma EIA was approved for clinical for on-site use, and therefore useful for regions outside the United States. However, ALPHA-HUAg is considered inferior to the MVista-HUAg which is only available on referral. We aim to evaluate the diagnostic accuracy of ALPHA-HUAg. METHODOLOGY/PRINCIPAL FINDINGS: We conducted a multicenter, prospective, diagnostic test study in two secondary and eight tertiary-care facilities in Mexico. We included HIV patient with PDH suspicion and evaluated ALPHA-HUAg diagnostic accuracy using as reference standard the Histoplasma capsulatum growth on blood, bone marrow, and tissue cultures or compatible histopathologic exam (PDH-proven). We evaluated the results of 288 patients, 29.5% (85/288; 95% confidence interval [CI], 24.3-35.1) had PDH. The sensitivity of ALPHA-HUAg was 67.1% (95% CI, 56-76.8%) and the specificity was 97.5% (95% CI, 94.3%-99.1%). The positive likelihood ratio was 27.2 (95% CI; 11.6-74.4). In 10.5% of the PDH-proven patients, a co-existing opportunistic infection was diagnosed, mostly disseminated Mycobacterium avium complex infection. CONCLUSIONS/SIGNIFICANCE: We observed a high specificity but low sensitivity of IMMY-HUAg. The test may be useful to start early antifungals, but a culture-based approach is necessary since co-infections are frequent and a negative IMMY-HUAg result does not rule out PDH. SN - 1935-2735 UR - https://www.unboundmedicine.com/medline/citation/30395572/Diagnostic_accuracy_cohort_study_and_clinical_value_of_the_Histoplasma_urine_antigen__ALPHA_Histoplasma_EIA__for_disseminated_histoplasmosis_among_HIV_infected_patients:_A_multicenter_study_ L2 - http://dx.plos.org/10.1371/journal.pntd.0006872 DB - PRIME DP - Unbound Medicine ER -