Validation and Concordance Analysis of a New Lateral Flow Assay for Detection of Histoplasma Antigen in Urine

Journal of Fungi

Mark D. Lindsley¹  Tom Chiller¹  Diego H. Cáceres¹  Ángela M. Tobón²  Nicole Bridges³  Melissa Minderman³  Beatriz L. Gómez⁴ 

[1] Centers for Disease Control and Prevention CDC, Atlanta, GA 30329, USA;Hospital La Maria, Medellín 050040, Colombia;MiraVista Diagnostics, Indianapolis, IN 46241, USA;Studies in Translational Microbiology and Emerging Diseases (MICROS Research Group), School of Medicine and Health Sciences, Universidad del Rosario, Bogota 111221, Colombia;

关键词: histoplasmosis;    Histoplasma;    antigen;    HIV;    AIDS;   

DOI  :  10.3390/jof7100799

来源: DOAJ

【 摘 要 】

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.

【 授权许可】

Unknown