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.

• Main Authors: Pedro Torres-González (Author), María Dolores Niembro-Ortega (Author), Areli Martínez-Gamboa (Author), Víctor Hugo Ahumada-Topete (Author), Jaime Andrade-Villanueva (Author), Javier Araujo-Meléndez (Author), Alberto Chaparro-Sánchez (Author), Brenda Crabtree-Ramírez (Author), Sofia Cruz-Martínez (Author), Armando Gamboa-Domínguez (Author), Oscar I Flores-Barrientos (Author), Jesús Enrique Gaytán-Martínez (Author), Luz Alicia González-Hernández (Author), Christian Hernández-León (Author), Víctor Hugo Lozano-Fernandez (Author), Marisol Manríquez-Reyes (Author), Martin Magaña-Aquino (Author), Pedro Martínez-Ayala (Author), Juan Pablo Ramírez-Hinojosa (Author), Andrea Rangel-Cordero (Author), Norma Erendira Rivera-Martínez (Author), Edgardo Reyes-Gutiérrez (Author), Gustavo Reyes-Terán (Author), Patricia Rodríguez-Zulueta (Author), Jesús Ruíz-Quiñones (Author), Janeth Santiago-Cruz (Author), Nancy Guadalupe Velázquez-Zavala (Author), José Sifuentes-Osornio (Author), Alfredo Ponce de León (Author)
• Format: Book
• Published: Public Library of Science (PLoS), 2018-11-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.
• Notes: 1935-2727; 1935-2735; 10.1371/journal.pntd.0006872
• Keywords: Arctic medicine. Tropical medicine; RC955-962; Public aspects of medicine; RA1-1270
• Source: PLoS Neglected Tropical Diseases, Vol 12, Iss 11, p e0006872 (2018)

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.