Validation and Concordance Analysis of a New Lateral Flow Assay for Detection of <i>Histoplasma</i> Antigen in Urine
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<...
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| Format: | Article |
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MDPI AG
2021-09-01
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| Series: | Journal of Fungi |
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| Online Access: | https://www.mdpi.com/2309-608X/7/10/799 |
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| author | Diego H. Cáceres Beatriz L. Gómez Ángela M. Tobón Melissa Minderman Nicole Bridges Tom Chiller Mark D. Lindsley |
| author_facet | Diego H. Cáceres Beatriz L. Gómez Ángela M. Tobón Melissa Minderman Nicole Bridges Tom Chiller Mark D. Lindsley |
| author_sort | Diego H. Cáceres |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-10T06:28:17Z |
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| institution | Directory Open Access Journal |
| issn | 2309-608X |
| language | English |
| last_indexed | 2024-03-10T06:28:17Z |
| publishDate | 2021-09-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Journal of Fungi |
| spelling | doaj.art-c9fa2ab0c92542e3992057cd2b0f7d4c2023-11-22T18:46:38ZengMDPI AGJournal of Fungi2309-608X2021-09-0171079910.3390/jof7100799Validation and Concordance Analysis of a New Lateral Flow Assay for Detection of <i>Histoplasma</i> Antigen in UrineDiego H. Cáceres0Beatriz L. Gómez1Ángela M. Tobón2Melissa Minderman3Nicole Bridges4Tom Chiller5Mark D. Lindsley6Centers for Disease Control and Prevention CDC, Atlanta, GA 30329, USAStudies in Translational Microbiology and Emerging Diseases (MICROS Research Group), School of Medicine and Health Sciences, Universidad del Rosario, Bogota 111221, ColombiaHospital La Maria, Medellín 050040, ColombiaMiraVista Diagnostics, Indianapolis, IN 46241, USAMiraVista Diagnostics, Indianapolis, IN 46241, USACenters for Disease Control and Prevention CDC, Atlanta, GA 30329, USACenters for Disease Control and Prevention CDC, Atlanta, GA 30329, USAHistoplasmosis 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.https://www.mdpi.com/2309-608X/7/10/799histoplasmosis<i>Histoplasma</i>antigenHIVAIDS |
| spellingShingle | Diego H. Cáceres Beatriz L. Gómez Ángela M. Tobón Melissa Minderman Nicole Bridges Tom Chiller Mark D. Lindsley Validation and Concordance Analysis of a New Lateral Flow Assay for Detection of <i>Histoplasma</i> Antigen in Urine Journal of Fungi histoplasmosis <i>Histoplasma</i> antigen HIV AIDS |
| title | Validation and Concordance Analysis of a New Lateral Flow Assay for Detection of <i>Histoplasma</i> Antigen in Urine |
| title_full | Validation and Concordance Analysis of a New Lateral Flow Assay for Detection of <i>Histoplasma</i> Antigen in Urine |
| title_fullStr | Validation and Concordance Analysis of a New Lateral Flow Assay for Detection of <i>Histoplasma</i> Antigen in Urine |
| title_full_unstemmed | Validation and Concordance Analysis of a New Lateral Flow Assay for Detection of <i>Histoplasma</i> Antigen in Urine |
| title_short | Validation and Concordance Analysis of a New Lateral Flow Assay for Detection of <i>Histoplasma</i> Antigen in Urine |
| title_sort | validation and concordance analysis of a new lateral flow assay for detection of i histoplasma i antigen in urine |
| topic | histoplasmosis <i>Histoplasma</i> antigen HIV AIDS |
| url | https://www.mdpi.com/2309-608X/7/10/799 |
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