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

Autor: Alfredo Ponce de León, Luz A. González-Hernández, Marisol Manríquez-Reyes, Brenda Crabtree-Ramírez, Jesús Gaytán-Martínez, Norma Erendira Rivera-Martínez, Edgardo Reyes-Gutiérrez, Janeth Santiago-Cruz, Pedro Torres-González, Pedro Martínez-Ayala, Andrea Rangel-Cordero, Nancy Guadalupe Velázquez-Zavala, Oscar I. Flores-Barrientos, Jesús Arturo Ruiz-Quiñones, Christian Hernández-León, Armando Gamboa-Domínguez, Sofia Cruz-Martínez, Alberto Chaparro-Sánchez, Areli Martínez-Gamboa, José Sifuentes-Osornio, Víctor Hugo Lozano-Fernandez, Gustavo Reyes-Terán, Martín Magaña-Aquino, Jaime Andrade-Villanueva, Patricia Rodríguez-Zulueta, Víctor Hugo Ahumada-Topete, Javier Araujo-Meléndez, Juan Pablo Ramírez-Hinojosa, María Dolores Niembro-Ortega
Jazyk: angličtina
Rok vydání: 2018
Předmět:
0301 basic medicine
Male
Opportunistic infection
Physiology
HIV Infections
Urine
Pathology and Laboratory Medicine
Likelihood ratios in diagnostic testing
0302 clinical medicine
Bone Marrow
Immune Physiology
Epidemiology
Medicine
030212 general & internal medicine
Prospective Studies
Prospective cohort study
Histoplasmosis
Fungal Pathogens
biology
lcsh:Public aspects of medicine
Fungal Diseases
Progressive disseminated histoplasmosis
HIV diagnosis and management
Body Fluids
Infectious Diseases
Blood
Medical Microbiology
Tuberculosis Diagnosis and Management
Histoplasma Capsulatum
Female
Anatomy
Pathogens
Cohort study
Research Article
Adult
medicine.medical_specialty
lcsh:Arctic medicine. Tropical medicine
Antigens
Fungal
lcsh:RC955-962
030106 microbiology
Immunology
Histoplasma
Mycology
Microbiology
03 medical and health sciences
Internal medicine
Humans
Microbial Pathogens
Mexico
Medicine and health sciences
business.industry
Diagnostic Tests
Routine
Public Health
Environmental and Occupational Health
Biology and Life Sciences
lcsh:RA1-1270
biology.organism_classification
medicine.disease
Diagnostic medicine
Immune System
business
Zdroj: PLoS Neglected Tropical Diseases
PLoS Neglected Tropical Diseases, Vol 12, Iss 11, p e0006872 (2018)
ISSN: 1935-2735
1935-2727
Popis: 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.
Author summary Histoplasmosis is an endemic mycosis in many regions of Latin America. In the HIV population it manifests as progressive disseminated histoplasmosis (PDH), an entity hard to diagnose since the causative fungi—Histoplasma capsulatum—is slow growing and requires advance biosafety for its handling. As an alternative, the diagnosis can be made by detecting the histoplasma urinary antigen, but only one kit is commercially available outside the US. We evaluated this kit (IMMY ALPHA Histoplasma EIA) among HIV patients with suspected and found a high specificity but low sensitivity (i.e., a positive histoplasma urine antigen is almost unequivocal, but a negative result does not rule out the PDH). However, we believe the test is useful since the positive likelihood rates show that a patient with PDH is 27 times more likely to have an IMMY-HUAg positive result; this may allow early targeted treatment.
Databáze: OpenAIRE
Externí odkaz:
Nepřihlášeným uživatelům se plný text nezobrazuje