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Validation and Concordance Analysis of a New Lateral Flow Assay for Detection of <i>Histoplasma</i> Antigen in Urine
oleh: Diego H. Cáceres, Beatriz L. Gómez, Ángela M. Tobón, Melissa Minderman, Nicole Bridges, Tom Chiller, Mark D. Lindsley
| Format: | Article |
|---|---|
| Diterbitkan: | MDPI AG 2021-09-01 |
Deskripsi
Histoplasmosis is a major cause of mortality in people living with HIV (PLHIV). Rapid methods to diagnose <i>Histoplasma capsulatum</i> disease could dramatically decrease the time to initiate treatment, resulting in reduced mortality. The aim of this study was to validate a MiraVista<sup>®</sup> Diagnostics (MVD) <i>Histoplasma</i> urine antigen lateral flow assay (MVD LFA) for the detection of <i>H. capsulatum</i> antigen (Ag) in urine and compare this LFA against the MVista<sup>®</sup> <i>Histoplasma</i> 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.