IVD Devices: Histoplasma Urine Antigen LFA

• May 26th, 2020 - Review our May 26th, 2020 Press Release regarding this new announcement
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• Diego H. Cáceres, et al. Validation and Concordance Analysis of a New Lateral Flow Assay for Detection of Histoplasma Antigen in Urine. Journal of Fungi 2021.
• Wassim Abdallah, et al. Diagnosis of Histoplasmosis Using the MVista Histoplasma Galactomannan Antigen Qualitative Lateral Flow–Based Immunoassay: A Multicenter Study. Open Forum Infectious Diseases 2021.
• Martinez-Gamboa, et al. Diagnostic accuracy of antigen detection in urine and molecular assays testing in different clinical samples for the diagnosis of progressive disseminated histoplasmosis in patients living with HIV/AIDS: A prospective multicenter study in Mexico. PLoS Negl Trop Dis. 2021 Mar 8;15(3)

Background

Histoplasmosis is a systemic infection caused by the dimorphic fungus Histoplasma capsulatum. Rapid diagnosis is important for early initiation of treatment in progressive disseminated and acute pulmonary histoplasmosis cases. Antigen detection has been proven useful for rapid diagnosis.

Development

We have developed an easy-to-use immunochromatographic lateral flow assay (LFA) for the visual detection of Histoplasma galactomannan antigen in urine.

The MiraVista Histoplasma Urine Antigen LFA test can aid in the diagnosis of Histoplasma infection.

Performance

The MiraVista Histoplasma Urine Antigen LFA has a proven clinical sensitivity of 93.18% and 96.97%

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