{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,9]],"date-time":"2026-09-09T03:11:09Z","timestamp":1788923469841,"version":"build-2803163510"},"reference-count":34,"publisher":"MDPI AG","issue":"10","license":[{"start":{"date-parts":[[2021,9,24]],"date-time":"2021-09-24T00:00:00Z","timestamp":1632441600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JoF"],"abstract":"<jats:p>Histoplasmosis is a major cause of mortality in people living with HIV (PLHIV). Rapid methods to diagnose Histoplasma capsulatum disease could dramatically decrease the time to initiate treatment, resulting in reduced mortality. The aim of this study was to validate a MiraVista\u00ae Diagnostics (MVD) Histoplasma urine antigen lateral flow assay (MVD LFA) for the detection of H. capsulatum antigen (Ag) in urine and compare this LFA against the MVista\u00ae\u00a0Histoplasma Ag quantitative enzyme immunoassays (MVD EIA). We assessed the MVD LFA using a standardized reference panel of urine specimens from Colombia. We tested 100 urine specimens, 26 from PLHIV diagnosed with histoplasmosis, 42 from PLHIV with other infectious diseases, and 32 from non-HIV infected persons without histoplasmosis. Sensitivity and specificity of the MVD LFA was 96%, compared with 96% sensitivity and 77% specificity of the MVD EIA. Concordance analysis between MVD LFA and the MVD EIA displayed an 84% agreement, and a Kappa of 0.656. The MVD LFA evaluated in this study has several advantages, including a turnaround time for results of approximately 40 min, no need for complex laboratory infrastructure or highly trained laboratory personnel, use of urine specimens, and ease of performing.<\/jats:p>","DOI":"10.3390\/jof7100799","type":"journal-article","created":{"date-parts":[[2021,9,27]],"date-time":"2021-09-27T04:55:33Z","timestamp":1632718533000},"page":"799","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":33,"title":["Validation and Concordance Analysis of a New Lateral Flow Assay for Detection of Histoplasma Antigen in Urine"],"prefix":"10.3390","volume":"7","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8749-9809","authenticated-orcid":false,"given":"Diego H.","family":"C\u00e1ceres","sequence":"first","affiliation":[{"name":"Centers for Disease Control and Prevention CDC, Atlanta, GA 30329, USA"},{"name":"Center of Expertise in Mycology Radboudumc\/CWZ, 6525 Nijmegen, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Beatriz L.","family":"G\u00f3mez","sequence":"additional","affiliation":[{"name":"Studies in Translational Microbiology and Emerging Diseases (MICROS Research Group), School of Medicine and Health Sciences, Universidad del Rosario, Bogota 111221, Colombia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"\u00c1ngela M.","family":"Tob\u00f3n","sequence":"additional","affiliation":[{"name":"Hospital La Maria, Medell\u00edn 050040, Colombia"},{"name":"Instituto Colombiano de Medicina Tropical, Universidad CES, Medell\u00edn 050021, Colombia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Melissa","family":"Minderman","sequence":"additional","affiliation":[{"name":"MiraVista Diagnostics, Indianapolis, IN 46241, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicole","family":"Bridges","sequence":"additional","affiliation":[{"name":"MiraVista Diagnostics, Indianapolis, IN 46241, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2251-8033","authenticated-orcid":false,"given":"Tom","family":"Chiller","sequence":"additional","affiliation":[{"name":"Centers for Disease Control and Prevention CDC, Atlanta, GA 30329, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark D.","family":"Lindsley","sequence":"additional","affiliation":[{"name":"Centers for Disease Control and Prevention CDC, Atlanta, GA 30329, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2021,9,24]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"70","DOI":"10.1007\/s40475-015-0044-0","article-title":"Histoplasmosis infections worldwide: Thinking outside of the Ohio River valley","volume":"2","author":"Bahr","year":"2015","journal-title":"Curr. Trop. Med. Rep."},{"key":"ref_2","doi-asserted-by":"crossref","unstructured":"Lockhart, S.R., Toda, M., Benedict, K., Caceres, D.H., and Litvintseva, A.P. (2021). Endemic and Other Dimorphic Mycoses in The Americas. J. Fungi, 7.","DOI":"10.3390\/jof7020151"},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"918","DOI":"10.4269\/ajtmh.15-0837","article-title":"Clinical and Laboratory Profile of Persons Living with Human Immunodeficiency Virus\/Acquired Immune Deficiency Syndrome and Histoplasmosis from a Colombian Hospital","volume":"95","author":"Caceres","year":"2016","journal-title":"Am. J. Trop. Med. Hyg."},{"key":"ref_4","doi-asserted-by":"crossref","unstructured":"Deepe, G.S., Dolin, R., and Blaser, M.J. (2015). 265-Histoplasma capsulatum (Histoplasmosis) A2-Bennett, John E. Mandell, Douglas, and Bennett\u2019s Principles and Practice of Infectious Diseases, Content Repository Only. [9th ed.].","DOI":"10.1016\/B978-1-4557-4801-3.00265-4"},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"1150","DOI":"10.1016\/S1473-3099(18)30354-2","article-title":"Burden of HIV-associated histoplasmosis compared with tuberculosis in Latin America: A modelling study","volume":"18","author":"Adenis","year":"2018","journal-title":"Lancet Infect. Dis."},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"216","DOI":"10.4269\/ajtmh.13-0084","article-title":"Tuberculosis and histoplasmosis among human immunodeficiency virus-infected patients: A comparative study","volume":"90","author":"Adenis","year":"2014","journal-title":"Am. J. Trop. Med. Hyg."},{"key":"ref_7","doi-asserted-by":"crossref","unstructured":"Caceres, D.H., and Valdes, A. (2019). Histoplasmosis and Tuberculosis Co-Occurrence in People with Advanced HIV. J. Fungi, 5.","DOI":"10.3390\/jof5030073"},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"41","DOI":"10.1016\/j.mmcr.2017.07.004","article-title":"The important role of co-infections in patients with AIDS and progressive disseminated histoplasmosis (PDH): A cohort from Colombia","volume":"19","author":"Caceres","year":"2018","journal-title":"Med. Mycol. Case Rep."},{"key":"ref_9","doi-asserted-by":"crossref","unstructured":"Nacher, M., Leitao, T.S., Gomez, B.L., Couppie, P., Adenis, A., Damasceno, L., Demar, M., Samayoa, B., Caceres, D.H., and Pradinaud, R. (2019). The Fight against HIV-Associated Disseminated Histoplasmosis in the Americas: Unfolding the Different Stories of Four Centers. J. Fungi, 5.","DOI":"10.3390\/jof5020051"},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"44","DOI":"10.1016\/S0123-9392(12)70026-7","article-title":"Histoplasmosis y sida: Factores de riesgo cl\u00ednicos y de laboratorio asociados al pron\u00f3stico de la enfermedad","volume":"16","author":"Restrepo","year":"2012","journal-title":"Infectio"},{"key":"ref_11","doi-asserted-by":"crossref","unstructured":"Caceres, D.H., Knuth, M., Derado, G., and Lindsley, M.D. (2019). Diagnosis of Progressive Disseminated Histoplasmosis in Advanced HIV: A Meta-Analysis of Assay Analytical Performance. J. Fungi, 5.","DOI":"10.3390\/jof5030076"},{"key":"ref_12","unstructured":"PAHO\/WHO (2021, August 01). Guidelines for Diagnosing and Managing Disseminated Histoplasmosis among People Living with HIV. Available online: https:\/\/iris.paho.org\/bitstream\/handle\/10665.2\/52304\/9789275122495_eng.pdf?sequence=1&isAllowed=y."},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"396","DOI":"10.1016\/S0002-9343(89)80820-4","article-title":"Histoplasma capsulatum polysaccharide antigen detection in diagnosis and management of disseminated histoplasmosis in patients with acquired immunodeficiency syndrome","volume":"87","author":"Wheat","year":"1989","journal-title":"Am. J. Med."},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"320","DOI":"10.1128\/CVI.00409-08","article-title":"Improved detection of Histoplasma antigenemia following dissociation of immune complexes","volume":"16","author":"Swartzentruber","year":"2009","journal-title":"Clin. Vaccine Immunol."},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"1587","DOI":"10.1128\/CVI.00071-07","article-title":"Detection of histoplasma antigen by a quantitative enzyme immunoassay","volume":"14","author":"Connolly","year":"2007","journal-title":"Clin. Vaccine Immunol."},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"e01959-17","DOI":"10.1128\/JCM.01959-17","article-title":"Multicenter Validation of Commercial Antigenuria Reagents To Diagnose Progressive Disseminated Histoplasmosis in People Living with HIV\/AIDS in Two Latin American Countries","volume":"56","author":"Caceres","year":"2018","journal-title":"J. Clin. Microbiol."},{"key":"ref_17","doi-asserted-by":"crossref","unstructured":"Mart\u00ednez-Gamboa, A., Niembro-Ortega, M.D., Torres-Gonz\u00e1lez, P., Santiago-Cruz, J., Vel\u00e1zquez-Zavala, N.G., Rangel-Cordero, A., Crabtree-Ram\u00edrez, B., Gamboa-Dom\u00ednguez, A., Reyes-Guti\u00e9rrez, E., and Reyes-Ter\u00e1n, G. (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 Negl. Trop. Dis., 15.","DOI":"10.1371\/journal.pntd.0009215"},{"key":"ref_18","doi-asserted-by":"crossref","unstructured":"Caceres, D.H., Arauz, A.B., Flores, C., Santiago, E., Montoya, S., Saenz, C., Torres-Meneses, F.A., Peralta, H., Zuniga-Moya, J.C., and Lainez Arteaga, I.Z. (2021). Implementation of rapid diagnostics assays for detection of histoplasmosis and cryptococcosis in central american people living with HIV. Mycoses.","DOI":"10.1111\/myc.13303"},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"1625","DOI":"10.1097\/QAD.0000000000002631","article-title":"Comparative performance of the laboratory assays used by a Diagnostic Laboratory Hub for opportunistic infections in people living with HIV","volume":"34","author":"Medina","year":"2020","journal-title":"Aids"},{"key":"ref_20","doi-asserted-by":"crossref","first-page":"ofz073","DOI":"10.1093\/ofid\/ofz073","article-title":"Histoplasmosis, An Underdiagnosed Disease Affecting People Living With HIV\/AIDS in Brazil: Results of a Multicenter Prospective Cohort Study Using Both Classical Mycology Tests and Histoplasma Urine Antigen Detection","volume":"6","author":"Falci","year":"2019","journal-title":"Open Forum Infect. Dis."},{"key":"ref_21","doi-asserted-by":"crossref","first-page":"20","DOI":"10.1111\/myc.12536","article-title":"Disseminated histoplasmosis and AIDS: A prospective and multicentre study to evaluate the performance of different diagnostic tests","volume":"60","author":"Hoffmann","year":"2017","journal-title":"Mycoses"},{"key":"ref_22","doi-asserted-by":"crossref","first-page":"916","DOI":"10.1093\/mmy\/myab022","article-title":"Combining urine antigen and blood polymerase chain reaction for the diagnosis of disseminated histoplasmosis in hospitalized patients with advanced HIV disease","volume":"59","author":"Vidal","year":"2021","journal-title":"Med. Mycol."},{"key":"ref_23","doi-asserted-by":"crossref","first-page":"502","DOI":"10.1111\/myc.12902","article-title":"Can urinary histoplasma antigen test improve the diagnosis of histoplasmosis in a tuberculosis endemic region?","volume":"62","author":"Bansal","year":"2019","journal-title":"Mycoses"},{"key":"ref_24","doi-asserted-by":"crossref","first-page":"51","DOI":"10.1186\/s12981-021-00377-5","article-title":"Closing gaps in histoplasmosis: Clinical characteristics and factors associated with probable\/histoplasmosis in HIV\/AIDS hospitalized patients, a retrospective cross-sectional study in two tertiary centers in Pereira, Colombia","volume":"18","year":"2021","journal-title":"AIDS Res. Ther."},{"key":"ref_25","doi-asserted-by":"crossref","first-page":"672","DOI":"10.1093\/mmy\/myaa100","article-title":"Cross-reactivity of a Histoplasma capsulatum antigen enzyme immunoassay in urine specimens from persons with emergomycosis in South Africa","volume":"59","author":"Maphanga","year":"2021","journal-title":"Med. Mycol."},{"key":"ref_26","doi-asserted-by":"crossref","first-page":"1364","DOI":"10.1128\/CVI.00101-14","article-title":"Validation of an enzyme-linked immunosorbent assay that detects Histoplasma capsulatum antigenuria in Colombian patients with AIDS for diagnosis and follow-up during therapy","volume":"21","author":"Caceres","year":"2014","journal-title":"Clin. Vaccine Immunol."},{"key":"ref_27","doi-asserted-by":"crossref","first-page":"1367","DOI":"10.1093\/cid\/ciz1008","article-title":"Revision and Update of the Consensus Definitions of Invasive Fungal Disease From the European Organization for Research and Treatment of Cancer and the Mycoses Study Group Education and Research Consortium","volume":"71","author":"Donnelly","year":"2019","journal-title":"Clin. Infect. Dis."},{"key":"ref_28","unstructured":"Diagnostics, M. (2021, August 01). Histoplasma Quantitative EIA Test. Available online: https:\/\/miravistalabs.com\/medical-fungal-infection-testing\/antigen-detection\/histoplasma-quantitative-eia-test\/."},{"key":"ref_29","unstructured":"Orozco-Vargas, L.C. (2010). Medicion en Salud : Diagnostico y Evaluacion de Resultados: Un Manual Critico mas Alla de lo Basic, Universidad Industrial de Santander."},{"key":"ref_30","doi-asserted-by":"crossref","first-page":"139","DOI":"10.1111\/myc.13023","article-title":"Evaluation of a Histoplasma antigen lateral flow assay for the rapid diagnosis of progressive disseminated histoplasmosis in Colombian patients with AIDS","volume":"63","author":"Caceres","year":"2020","journal-title":"Mycoses"},{"key":"ref_31","doi-asserted-by":"crossref","first-page":"3978","DOI":"10.1128\/AAC.00793-10","article-title":"In vitro effect of sulfamethoxazole-trimethoprim against Histoplasma capsulatum var. capsulatum","volume":"54","author":"Brilhante","year":"2010","journal-title":"Antimicrob. Agents Chemother."},{"key":"ref_32","doi-asserted-by":"crossref","first-page":"29","DOI":"10.1016\/S0732-8893(02)00367-X","article-title":"Diagnosis of histoplasmosis by antigen detection based upon experience at the histoplasmosis reference laboratory","volume":"43","author":"Wheat","year":"2002","journal-title":"Diagn Microbiol Infect. Dis."},{"key":"ref_33","doi-asserted-by":"crossref","first-page":"1169","DOI":"10.1086\/513647","article-title":"Cross-reactivity in Histoplasma capsulatum variety capsulatum antigen assays of urine samples from patients with endemic mycoses","volume":"24","author":"Wheat","year":"1997","journal-title":"Clin. Infect. Dis."},{"key":"ref_34","doi-asserted-by":"crossref","first-page":"868","DOI":"10.1093\/mmy\/myv062","article-title":"Evaluation of two new enzyme immunoassay reagents for diagnosis of histoplasmosis in a cohort of clinically characterized patients","volume":"53","author":"Zhang","year":"2015","journal-title":"Med. Mycol."}],"container-title":["Journal of Fungi"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2309-608X\/7\/10\/799\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,11]],"date-time":"2025-10-11T07:04:44Z","timestamp":1760166284000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2309-608X\/7\/10\/799"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,9,24]]},"references-count":34,"journal-issue":{"issue":"10","published-online":{"date-parts":[[2021,10]]}},"alternative-id":["jof7100799"],"URL":"https:\/\/doi.org\/10.3390\/jof7100799","relation":{},"ISSN":["2309-608X"],"issn-type":[{"value":"2309-608X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,9,24]]}}}