Evaluation of a Histoplasma antigen lateral flow assay for the rapid diagnosis of progressive disseminated histoplasmosis in Colombian patients with AIDS.

Publisher: Grosse Verlag Country of Publication: Germany NLM ID: 8805008 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1439-0507 (Electronic) Linking ISSN: 09337407 NLM ISO Abbreviation: Mycoses Subsets: MEDLINE

Original Publication: Berlin : Grosse Verlag, [1988?-

Acquired Immunodeficiency Syndrome/*complications ; Antigens, Fungal/*blood ; Histoplasma/*immunology ; Histoplasmosis/*diagnosis ; Immunoassay/*standards; Animals ; Antigens, Fungal/immunology ; Colombia ; Confidence Intervals ; Cross Reactions ; Galactose/analogs & derivatives ; Histoplasmosis/immunology ; Humans ; Immunoassay/methods ; Mannans/blood ; Mannans/immunology ; Paracoccidioidomycosis/diagnosis ; Paracoccidioidomycosis/immunology ; Point-of-Care Systems/standards ; Predictive Value of Tests ; Rabbits ; Sensitivity and Specificity

Background: Progressive disseminated histoplasmosis (PDH) is an important cause of mortality in persons living with HIV (PLHIV), especially in countries where patients have limited access to antiretroviral therapies and diagnostic testing.
Objective: A lateral flow assay (LFA) to detect Histoplasma capsulatum antigen in serum developed by MiraVista ^® was evaluated.
Methods: We tested 75 serum samples: 24 from PLHIV and culture-proven PDH and 51 from PLHIV with other fungal and bacterial infections as well as people without HIV. LFA devices were read manually (read by eye) and by an automated reader.
Results: When the LFA was read manually, sensitivity was 96% and specificity was 90%. When an automated reader was used, sensitivity was 92% and specificity was 94%. The Kappa index comparing manual and automated reader was 0.90. Cross-reactions were observed principally in samples from patients with proven diagnosis of paracoccidioidomycosis.
Conclusions: The MiraVista ^® Diagnostics Histoplasma antigen LFA had high analytical performance and good agreement between manual and automated reader. This LFA allows Histoplasma antigen testing with minimal laboratory equipment and infrastructure requirements.
(© 2019 Blackwell Verlag GmbH.)

Deepe GS. Histoplasma capsulatum. In: Bennett JE, Dolin R, Blaser MJ, eds. Principles and Practice of Infectious Diseases, 8th edn. Philadelphia, PA: Elsevier; 2015:2949-2962.
Caceres DH, Tobón ÁM, Restrepo Á, Chiller T, Gómez BL. The important role of co-infections in patients with AIDS and progressive disseminated histoplasmosis (PDH): a cohort from Colombia. Med Mycol Case Rep. 2018;19:41-44. https://www.ncbi.nlm.nih.gov/pubmed/29379705.
Nacher M, Adenis A, Sambourg E, et al. Histoplasmosis or tuberculosis in HIV-infected patients in the amazon: what should be treated first? PLoS Negl Trop Dis. 2014;8:e3290. https://www.ncbi.nlm.nih.gov/pubmed/25474641.
Adenis A, Nacher M, Hanf M, et al. Tuberculosis and histoplasmosis among human immunodeficiency virus-infected patients: a comparative study. Am J Trop Med Hyg. 2014;90:216-223. https://www.ncbi.nlm.nih.gov/pubmed/?term=Tuberculosis+and+histoplasmosis+among+human+immunodeficiency+virus-infected+patients%3A+a+comparative+study.
Caceres DH, Valdes A. Histoplasmosis and tuberculosis co-occurrence in people with advanced HIV. J Fungi (Basel). 2019;5:E73. https://www.ncbi.nlm.nih.gov/pubmed/31404979.
Kauffman CA. Diagnosis of histoplasmosis in immunosuppressed patients. Curr Opin Infect Dis. 2008;21:421-425. https://www.ncbi.nlm.nih.gov/pubmed/18594296.
Pfeiffer CD, Wong B. Diagnostic immunology. In: Hospenthal DR, Rinaldi MG, eds. Diagnosis and Treatment of Human Mycoses, 2nd edn. Basel, Switzerland: Springer International Publishing; 2015:45-64.
Almeida MA, Damasceno LS, Pizzini CV, Muniz MM, Almeida-Paes R, Zancopé-Oliveira RM. Role of western blot assay for the diagnosis of histoplasmosis in AIDS patients from a National Institute of Infectious Diseases in Rio de Janeiro, Brazil. Mycoses. 2019;62:261-267. https://onlinelibrary.wiley.com/doi/full/10.1111/myc.12877.
Cáceres DH, Samayoa BE, Medina NG, et al. Multicenter validation of commercial antigenuria reagents to diagnose progressive disseminated histoplasmosis in people living with HIV/AIDS in two Latin American Countries. J Clin Microbiol. 2018;56(6):e01959-e2017. https://www.ncbi.nlm.nih.gov/pubmed/29563205.
Caceres DH, Scheel C, Tobón AM, et al. Validation of an enzyme-linked immunosorbent assay that detects Histoplasma capsulatum antigenuria in Colombian patients with AIDS for diagnosis and follow-up during therapy. Clin Vaccine Immunol. 2014;21:1364-1368. https://www.ncbi.nlm.nih.gov/pubmed/?term=Validation+of+an+enzyme-linked+immunosorbent+assay+that+detects+Histoplasma+capsulatum+antigenuria+in+Colombian+patients+with+AIDS+for+diagnosis+and+follow-up+during+therapy.
Orozco LC. Validación de criterio o de la sensibilidad específica para predecir la calidad de las probabilidades, chapter 7, In: Orozco LC, ed. Medición en salud: diagnóstico y evaluación de resultados: un manual critico más allá de lo básico, 1st ed. Bucaramanga, Colombia: Universidad Industrial de Santander. 2010:115-157.
Brilhante RS, Fechine MA, Cordeiro Rde A, et al. In vitro effect of sulfamethoxazole-trimethoprim against Histoplasma capsulatum var. capsulatum. Antimicrob Agents Chemother. 2010;54(9):3978-3979. https://www.ncbi.nlm.nih.gov/pubmed/?term=In+Vitro+Effect+of+Sulfamethoxazole-Trimethoprim+against+Histoplasma+capsulatum+var.+capsulatum.+Antimicrob+Agents+Chemother.
Wheat J, Wheat H, Connolly P, et al. Cross-reactivity in Histoplasma capsulatum variety capsulatum antigen assays of urine samples from patients with endemic mycoses. Clin Infect Dis. 1997;24:1169-1171. https://www.ncbi.nlm.nih.gov/pubmed/?term=Cross-reactivity+in+Histoplasma+capsulatum+variety+capsulatum+antigen+assays+of+urine+samples+from+patients+with+endemic+mycoses.
Colombo AL, Tobon A, Restrepo A, Queiroz-Telles F, Nucci M. Epidemiology of endemic systemic fungal infections in Latin America. Med Mycol. 2011;49:785-798. https://www.ncbi.nlm.nih.gov/pubmed/21539506.
Boyce MR, Menya D, Turner EL, Laktabai J, Prudhomme-O'Meara W. Evaluation of malaria rapid diagnostic test (RDT) use by community health workers: a longitudinal study in western Kenya. Malar J. 2018;18:206. https://www.ncbi.nlm.nih.gov/pubmed/29776359.

0 (Antigens, Fungal)
0 (Mannans)
11078-30-1 (galactomannan)
X2RN3Q8DNE (Galactose)

Date Created: 20191019 Date Completed: 20200831 Latest Revision: 20211204

20250114

10.1111/myc.13023

31625627