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Diagnostic accuracy of antigen detection in urine and molecular assays testing in different clinical samples for the diagnosis of progressive disseminated histoplasmosis in patients living with HIV/AIDS: A prospective multicenter study in Mexico.
PLoS Negl Trop Dis. 2021 03; 15(3):e0009215.PN

Abstract

BACKGROUND

The progressive disseminated histoplasmosis (PDH) has been associated with severe disease and high risk of death among people living with HIV (PLWHIV). Therefore, the purpose of this multicenter, prospective, double-blinded study done in ten Mexican hospitals was to determine the diagnostic accuracy of detecting Histoplasma capsulatum antigen in urine using the IMMY ALPHA Histoplasma EIA kit (IAHE), clarus Histoplasma GM Enzyme Immunoassay (cHGEI IMMY) and MiraVista Histoplasma Urine Antigen LFA (MVHUALFA); as well as the Hcp100 and 1281-1283220SCAR nested PCRs in blood, bone-marrow, tissue biopsies and urine.

METHODOLOGY/PRINCIPAL FINDINGS

We included 415 PLWHIV older than 18 years of age with suspicion of PDH. Using as diagnostic standard recovery of H. capsulatum in blood, bone marrow or tissue cultures, or histopathological exam compatible, detected 108 patients (26%, [95%CI, 21.78-30.22]) with proven-PDH. We analyzed 391 urine samples by the IAHE, cHGEI IMMY and MVHUALFA; the sensitivity/specificity values obtained were 67.3% (95% CI, 57.4-76.2) / 96.2% (95% CI, 93.2-98.0) for IAHE, 91.3% (95% CI, 84.2-96.0) / 90.9% (95% CI, 87.0-94.0) for cHGEI IMMY and 90.4% (95% CI, 83.0-95.3) / 92.3% (95% CI, 88.6-95.1) for MVHUALFA. The Hcp100 nested PCR was performed on 393, 343, 75 and 297, blood, bone marrow, tissue and urine samples respectively; the sensitivity/specificity values obtained were 62.9% (95%CI, 53.3-72.5)/ 89.5% (95%CI, 86.0-93.0), 65.9% (95%CI, 56.0-75.8)/ 89.0% (95%CI, 85.2-92.9), 62.1% (95%CI, 44.4-79.7)/ 82.6% (95%CI, 71.7-93.6) and 34.9% (95%CI, 24.8-46.2)/ 67.3% (95%CI, 60.6-73.5) respectively; and 1281-1283220SCAR nested PCR was performed on 392, 344, 75 and 291, respectively; the sensitivity/specificity values obtained were 65.3% (95% CI, 55.9-74.7)/ 58.8% (95%CI, 53.2-64.5), 70.8% (95%CI, 61.3-80.2)/ 52.9% (95%CI, 46.8-59.1), 71.4% (95%CI, 54.7-88.2)/ 40.4% (95%CI, 26.4-54.5) and 18.1% (95%CI, 10.5-28.1)/ 90.4% (95%CI, 85.5-94.0), respectively.

CONCLUSIONS/SIGNIFICANCE

The cHGEI IMMY and MVHUALFA tests showed excellent performance for the diagnosis of PDH in PLWHIV. The integration of these tests in clinical laboratories will certainly impact on early diagnosis and treatment.

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.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.Department of Infectious Diseases, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán; Tlalpan, Mexico City, Mexico.Department of Pathology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Tlalpan, Mexico City, Mexico.Department of Pathology, 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 Cosio Villegas; Tlalpan, Mexico City, Mexico.Centro de Investigación en Enfermedades Infecciosas, Instituto Nacional de Enfermedades Respiratorias Ismael Cosio Villegas; Tlalpan, Mexico City, Mexico.Centro de Investigación en Enfermedades Infecciosas, Instituto Nacional de Enfermedades Respiratorias Ismael Cosio Villegas; Tlalpan, Mexico City, Mexico.HIV Unit, Hospital Civil de Guadalajara "Fray Antonio Alcalde"; Guadalajara, Jalisco, Mexico.Department of Internal Medicine, Hospital de Alta Especialidad de Veracruz; Veracruz, Veracruz, Mexico.Department of Infectious Diseases, Hospital General Dr. Manuel Gea González; Tlalpan, Mexico City, Mexico.Department of Infectious Diseases, Hospital General Dr. Manuel Gea González; Tlalpan, Mexico City, Mexico.Area of Infectious Diseases, Department of Internal Medicine, Hospital General de Puebla "Dr. Eduardo Vázquez Navarro"; Puebla, Puebla, Mexico.Intensive Care Unit, Department of Internal Medicine, Hospital "Dr. Juan Graham Casasus"; Villahermosa, Tabasco, Mexico.Adult Infectious Diseases Department, Hospital Regional de Alta Especialidad de Oaxaca, HRAEO; San Bartolo Coyotepec, Oaxaca, Mexico.Department of Infectious Diseases, Hospital de Infectología del Centro Médico Nacional "La Raza", Instituto Mexicano del Seguro Social; Azcapotzalco, Mexico City, Mexico.HIV Unit, Hospital Civil de Guadalajara "Fray Antonio Alcalde"; Guadalajara, Jalisco, Mexico.HIV Unit, Hospital Civil de Guadalajara "Fray Antonio Alcalde"; Guadalajara, Jalisco, Mexico.Adult Infectious Diseases Department, Hospital Regional de Alta Especialidad de Oaxaca, HRAEO; San Bartolo Coyotepec, Oaxaca, Mexico.Intensive Care Unit, Department of Internal Medicine, Hospital "Dr. Juan Graham Casasus"; Villahermosa, Tabasco, Mexico.Department of Infectious Diseases, Hospital de Infectología del Centro Médico Nacional "La Raza", Instituto Mexicano del Seguro Social; Azcapotzalco, Mexico City, Mexico.Department of Internal Medicine, Hospital Central Dr. Ignacio Morones Prieto; San Luis Potosí, San Luis Potosí, 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 Internal Medicine, Hospital Central Dr. Ignacio Morones Prieto; San Luis Potosí, San Luis Potosí, Mexico.Mycology Unit, Department of Microbiology and Parasitology, Facultad de Medicina, Universidad Nacional Autónoma de México, Mexico City, Mexico.Mycology Unit, Department of Microbiology and Parasitology, Facultad de Medicina, Universidad Nacional Autónoma de México, Mexico City, Mexico.Research unit, Hospital Regional de Alta Especialidad de Ixtapaluca, Mexico State, Mexico.Mycology Unit, Department of Microbiology and Parasitology, Facultad de Medicina, Universidad Nacional Autónoma de México, Mexico City, Mexico.Mycology Unit, Department of Microbiology and Parasitology, Facultad de Medicina, Universidad Nacional Autónoma de México, 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.

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

33684128

Citation

Martínez-Gamboa, Areli, et al. "Diagnostic Accuracy of Antigen Detection in Urine and Molecular Assays Testing in Different Clinical Samples for the Diagnosis of Progressive Disseminated Histoplasmosis in Patients Living With HIV/AIDS: a Prospective Multicenter Study in Mexico." PLoS Neglected Tropical Diseases, vol. 15, no. 3, 2021, pp. e0009215.
Martínez-Gamboa A, Niembro-Ortega MD, Torres-González P, et al. Diagnostic accuracy of antigen detection in urine and molecular assays testing in different clinical samples for the diagnosis of progressive disseminated histoplasmosis in patients living with HIV/AIDS: A prospective multicenter study in Mexico. PLoS Negl Trop Dis. 2021;15(3):e0009215.
Martínez-Gamboa, A., Niembro-Ortega, M. D., Torres-González, P., Santiago-Cruz, J., Velázquez-Zavala, N. G., Rangel-Cordero, A., Crabtree-Ramírez, B., Gamboa-Domínguez, A., Reyes-Gutiérrez, E., Reyes-Terán, G., Lozano-Fernandez, V. H., Ahumada-Topete, V. H., Martínez-Ayala, P., Manríquez-Reyes, M., Ramírez-Hinojosa, J. P., Rodríguez-Zulueta, P., Hernández-León, C., Ruíz-Quiñones, J., Rivera-Martínez, N. E., ... Sifuentes-Osornio, J. (2021). Diagnostic accuracy of antigen detection in urine and molecular assays testing in different clinical samples for the diagnosis of progressive disseminated histoplasmosis in patients living with HIV/AIDS: A prospective multicenter study in Mexico. PLoS Neglected Tropical Diseases, 15(3), e0009215. https://doi.org/10.1371/journal.pntd.0009215
Martínez-Gamboa A, et al. Diagnostic Accuracy of Antigen Detection in Urine and Molecular Assays Testing in Different Clinical Samples for the Diagnosis of Progressive Disseminated Histoplasmosis in Patients Living With HIV/AIDS: a Prospective Multicenter Study in Mexico. PLoS Negl Trop Dis. 2021;15(3):e0009215. PubMed PMID: 33684128.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Diagnostic accuracy of antigen detection in urine and molecular assays testing in different clinical samples for the diagnosis of progressive disseminated histoplasmosis in patients living with HIV/AIDS: A prospective multicenter study in Mexico. AU - Martínez-Gamboa,Areli, AU - Niembro-Ortega,María Dolores, AU - Torres-González,Pedro, AU - Santiago-Cruz,Janeth, AU - Velázquez-Zavala,Nancy Guadalupe, AU - Rangel-Cordero,Andrea, AU - Crabtree-Ramírez,Brenda, AU - Gamboa-Domínguez,Armando, AU - Reyes-Gutiérrez,Edgardo, AU - Reyes-Terán,Gustavo, AU - Lozano-Fernandez,Víctor Hugo, AU - Ahumada-Topete,Víctor Hugo, AU - Martínez-Ayala,Pedro, AU - Manríquez-Reyes,Marisol, AU - Ramírez-Hinojosa,Juan Pablo, AU - Rodríguez-Zulueta,Patricia, AU - Hernández-León,Christian, AU - Ruíz-Quiñones,Jesús, AU - Rivera-Martínez,Norma Eréndira, AU - Chaparro-Sánchez,Alberto, AU - Andrade-Villanueva,Jaime, AU - González-Hernández,Luz Alicia, AU - Cruz-Martínez,Sofia, AU - Flores-Barrientos,Oscar, AU - Gaytán-Martínez,Jesús Enrique, AU - Magaña-Aquino,Martín, AU - Cervantes-Sánchez,Axel, AU - Olivas-Martínez,Antonio, AU - Araujo-Meléndez,Javier, AU - Del Rocío Reyes-Montes,María, AU - Duarte-Escalante,Esperanza, AU - Frías-De León,María Guadalupe, AU - Ramírez,José Antonio, AU - Taylor,María Lucia, AU - de León-Garduño,Alfredo Ponce, AU - Sifuentes-Osornio,José, Y1 - 2021/03/08/ PY - 2020/09/12/received PY - 2021/02/06/accepted PY - 2021/03/18/revised PY - 2021/3/9/pubmed PY - 2021/6/25/medline PY - 2021/3/8/entrez SP - e0009215 EP - e0009215 JF - PLoS neglected tropical diseases JO - PLoS Negl Trop Dis VL - 15 IS - 3 N2 - BACKGROUND: The progressive disseminated histoplasmosis (PDH) has been associated with severe disease and high risk of death among people living with HIV (PLWHIV). Therefore, the purpose of this multicenter, prospective, double-blinded study done in ten Mexican hospitals was to determine the diagnostic accuracy of detecting Histoplasma capsulatum antigen in urine using the IMMY ALPHA Histoplasma EIA kit (IAHE), clarus Histoplasma GM Enzyme Immunoassay (cHGEI IMMY) and MiraVista Histoplasma Urine Antigen LFA (MVHUALFA); as well as the Hcp100 and 1281-1283220SCAR nested PCRs in blood, bone-marrow, tissue biopsies and urine. METHODOLOGY/PRINCIPAL FINDINGS: We included 415 PLWHIV older than 18 years of age with suspicion of PDH. Using as diagnostic standard recovery of H. capsulatum in blood, bone marrow or tissue cultures, or histopathological exam compatible, detected 108 patients (26%, [95%CI, 21.78-30.22]) with proven-PDH. We analyzed 391 urine samples by the IAHE, cHGEI IMMY and MVHUALFA; the sensitivity/specificity values obtained were 67.3% (95% CI, 57.4-76.2) / 96.2% (95% CI, 93.2-98.0) for IAHE, 91.3% (95% CI, 84.2-96.0) / 90.9% (95% CI, 87.0-94.0) for cHGEI IMMY and 90.4% (95% CI, 83.0-95.3) / 92.3% (95% CI, 88.6-95.1) for MVHUALFA. The Hcp100 nested PCR was performed on 393, 343, 75 and 297, blood, bone marrow, tissue and urine samples respectively; the sensitivity/specificity values obtained were 62.9% (95%CI, 53.3-72.5)/ 89.5% (95%CI, 86.0-93.0), 65.9% (95%CI, 56.0-75.8)/ 89.0% (95%CI, 85.2-92.9), 62.1% (95%CI, 44.4-79.7)/ 82.6% (95%CI, 71.7-93.6) and 34.9% (95%CI, 24.8-46.2)/ 67.3% (95%CI, 60.6-73.5) respectively; and 1281-1283220SCAR nested PCR was performed on 392, 344, 75 and 291, respectively; the sensitivity/specificity values obtained were 65.3% (95% CI, 55.9-74.7)/ 58.8% (95%CI, 53.2-64.5), 70.8% (95%CI, 61.3-80.2)/ 52.9% (95%CI, 46.8-59.1), 71.4% (95%CI, 54.7-88.2)/ 40.4% (95%CI, 26.4-54.5) and 18.1% (95%CI, 10.5-28.1)/ 90.4% (95%CI, 85.5-94.0), respectively. CONCLUSIONS/SIGNIFICANCE: The cHGEI IMMY and MVHUALFA tests showed excellent performance for the diagnosis of PDH in PLWHIV. The integration of these tests in clinical laboratories will certainly impact on early diagnosis and treatment. SN - 1935-2735 UR - https://www.unboundmedicine.com/medline/citation/33684128/Diagnostic_accuracy_of_antigen_detection_in_urine_and_molecular_assays_testing_in_different_clinical_samples_for_the_diagnosis_of_progressive_disseminated_histoplasmosis_in_patients_living_with_HIV/AIDS:_A_prospective_multicenter_study_in_Mexico_ L2 - https://dx.plos.org/10.1371/journal.pntd.0009215 DB - PRIME DP - Unbound Medicine ER -