Diagnosis of Histoplasmosis Using the MVista Histoplasma Galactomannan Antigen Qualitative Lateral Flow–Based Immunoassay: A Multicenter Study

dc.contributor.authorAbdallah, Wassim
dc.contributor.authorMyint, Thein
dc.contributor.authorLaRue, Richard
dc.contributor.authorMinderman, Melissa
dc.contributor.authorGunn, Suphansa
dc.contributor.authorWheat, L. Joseph
dc.contributor.authorHage, Chadi A.
dc.contributor.departmentMedicine, School of Medicineen_US
dc.date.accessioned2023-03-08T10:53:16Z
dc.date.available2023-03-08T10:53:16Z
dc.date.issued2021-08-31
dc.description.abstractBackground: Accurate and timely methods for the diagnosis of histoplasmosis in resource-limited countries are lacking. Histoplasma antigen detection by enzyme immunoassay (EIA) is widely used in the United States (US) but not in resource-limited countries, leading to missed or delayed diagnoses and poor outcomes. Lateral flow assays (LFAs) can be used in this setting. Methods: Frozen urine specimens were submitted to MiraVista diagnostics for antigen testing from 3 medical centers in endemic areas of the US. They were blinded and tested for the MVista Histoplasma LFA. Patients were classified as controls or cases of histoplasmosis. Cases were divided into proven or probable; pulmonary or disseminated; immunocompetent or immunosuppressed; and mild, moderate, or severe. Results: Three hundred fifty-two subjects were enrolled, including 66 cases (44 proven, 22 probable) and 286 controls. Most of the cases were immunocompromised (71%), and 46 had disseminated and 20 had pulmonary histoplasmosis. Four cases were mild, 42 moderate, and 20 severe. LFA and EIA were highly concordant (κ = 0.84). Sensitivity and specificity of the LFA were 78.8% and 99.3%, respectively. LFA sensitivity was higher in proven cases (93.2%), patients with disseminated (91.3%), moderate (78.6%), and severe disease (80%), and those with galactomannan levels >1.8 ng/mL (97.8%). Specificity was 99.3% in proven cases, 99.3% in patients with moderate or severe disease, and 96.8% in those with galactomannan levels >1.8 ng/mL. Cross-reactivity was noted with other endemic mycoses. Conclusions: The MVista Histoplasma LFA meets the need for accurate rapid diagnosis of histoplasmosis in resource-limited countries, especially in patients with high disease burden, potentially reducing morbidity and mortality.en_US
dc.eprint.versionFinal published versionen_US
dc.identifier.citationAbdallah W, Myint T, LaRue R, et al. Diagnosis of Histoplasmosis Using the MVista Histoplasma Galactomannan Antigen Qualitative Lateral Flow-Based Immunoassay: A Multicenter Study. Open Forum Infect Dis. 2021;8(9):ofab454. Published 2021 Aug 31. doi:10.1093/ofid/ofab454en_US
dc.identifier.urihttps://hdl.handle.net/1805/31707
dc.language.isoen_USen_US
dc.publisherOxford University Pressen_US
dc.relation.isversionof10.1093/ofid/ofab454en_US
dc.relation.journalOpen Forum Infectious Diseasesen_US
dc.rightsAttribution-NonCommercial-NoDerivatives 4.0 International*
dc.rights.urihttps://creativecommons.org/licenses/by-nc-nd/4.0*
dc.sourcePMCen_US
dc.subjectAntigenen_US
dc.subjectDiagnosisen_US
dc.subjectHistoplasmosisen_US
dc.titleDiagnosis of Histoplasmosis Using the MVista Histoplasma Galactomannan Antigen Qualitative Lateral Flow–Based Immunoassay: A Multicenter Studyen_US
dc.typeArticleen_US
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