Abstract
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® 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® Histoplasma 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.
Highlights
Study specimens: For use in this study, a standardized reference panel of 100 remnant urine specimens were selected from specimens obtained during a study of histoplasmosis in people living with HIV (PLHIV) conducted at the Hospital La María in Medellín, Colombia [26]
All patients from this study [26] were tested using multiple laboratory assays for fungal and mycobacteria infections. These testing was performed at the Medical and Experimental Mycology Unit at Corporación para Investigaciones Biológicas (CIB), a Colombian laboratory specialized in medical mycology, certified by the International Organization for Standardization (ISO) 9001:2015 and the Colombian regulatory agencies for medical services
lateral flow assay (LFA) result was observed from a patient who was diagnosed with culture-confirmed histoplasmosis (Table 1)
Summary
Publisher’s Note: MDPI stays neutral with regard to jurisdictional claims in published maps and institutional affiliations. Histoplasmosis is a disease caused by Histoplasma capsulatum, a thermally dimorphic fungus. Infection is most frequently diagnosed in the Americas, but histoplasmosis has been reported worldwide [1,2]. H. capsulatum is associated with soil contaminated with bird excreta and bat guano, and infection occurs when the host inhales the infectious fungal microconidia and mycelial fragments after disruption or aeration of the contaminated soil [1,2]. Histoplasmosis is primarily a pulmonary disease but may secondarily spread to other organs, especially those of the reticuloendothelial system [3,4]
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