Abstract
A sandwich enzyme immunoassay (EIA) for the detection of Histoplasma antigens (Ag) in urine, developed by Optimum Imaging Diagnostics (OIDx) was evaluated. A verification using a standardized reference panel of urine samples found sensitivity of 92%, specificity of 32% and accuracy of 51%. In this study, the OIDx Histoplasma urinary Ag EIA displayed high sensitivity, however, in non-histoplasmosis cases this EIA displayed false-positive results in 68% of specimens tested.
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Acknowledgements
The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention. This product evaluation was done under an agreement between OIDx and the CDC’s Mycotic Diseases Branch (Material Transfer Agreement # D-760-18).
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Cáceres, D.H., Gómez, B.L., Tobón, Á.M. et al. Evaluation of OIDx Histoplasma Urinary Antigen EIA. Mycopathologia 187, 129–131 (2022). https://doi.org/10.1007/s11046-021-00602-9
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DOI: https://doi.org/10.1007/s11046-021-00602-9