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Reevaluation of commercial reagents for detection of Histoplasma capsulatum antigen in urine.
J Clin Microbiol. 2015 Apr; 53(4):1198-203.JC

Abstract

Detection of the Histoplasma capsulatum urinary antigen (UAg) is among the most sensitive and rapid means to diagnose histoplasmosis. Previously, we evaluated analyte-specific reagents (ASR) manufactured by IMMY (Norman, OK) for detection of Histoplasma galactomannan (GM) in urine using an enzyme immunoassay (EIA), and we showed low positive agreement (64.5%) with the MiraVista (MVista) Histoplasma antigen (Ag) quantitative EIA (MiraVista Diagnostics, Indianapolis, IN). Here we reevaluated the IMMY GM ASR following modification of our original assay protocol and introduction of an indeterminate range. A total of 150 prospectively collected urine samples were tested with both the IMMY and MVista EIAs, and clinical histories were recorded for all study subjects. The IMMY GM ASR showed positive and negative agreements of 82.3% (14/17 samples) and 100% (121/121 samples), respectively (with exclusion of 12 indeterminate results), and overall agreement of 90% (135/150 samples) with respect to the MVista EIA. Of the three patients with negative IMMY GM ASR results and positive MVista EIA results, testing was performed for initial diagnostic purposes for one patient (<0.4 ng/ml by the MVista EIA) and UAg levels were being monitored for the remaining two patients (both<0.7 ng/ml by the MVista EIA). The MVista EIA results were positive for 6/12 samples that tested indeterminate by the IMMY GM ASR. We also show that the IMMY GM ASR can be used to serially monitor Histoplasma UAg levels. In conclusion, we demonstrate that, with modification, the IMMY GM ASR is a reliable rapid assay for detection of Histoplasma UAg.

Authors+Show Affiliations

Division of Clinical Microbiology, Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota, USA theel.elitza@mayo.edu.Division of Clinical Microbiology, Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota, USA.Division of Infectious Diseases, Mayo Clinic, Rochester, Minnesota, USA.Division of Clinical Microbiology, Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota, USA.Division of Clinical Microbiology, Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota, USA.Division of Clinical Microbiology, Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota, USA.

Pub Type(s)

Comparative Study
Evaluation Study
Journal Article

Language

eng

PubMed ID

25631806

Citation

Theel, Elitza S., et al. "Reevaluation of Commercial Reagents for Detection of Histoplasma Capsulatum Antigen in Urine." Journal of Clinical Microbiology, vol. 53, no. 4, 2015, pp. 1198-203.
Theel ES, Harring JA, Dababneh AS, et al. Reevaluation of commercial reagents for detection of Histoplasma capsulatum antigen in urine. J Clin Microbiol. 2015;53(4):1198-203.
Theel, E. S., Harring, J. A., Dababneh, A. S., Rollins, L. O., Bestrom, J. E., & Jespersen, D. J. (2015). Reevaluation of commercial reagents for detection of Histoplasma capsulatum antigen in urine. Journal of Clinical Microbiology, 53(4), 1198-203. https://doi.org/10.1128/JCM.03175-14
Theel ES, et al. Reevaluation of Commercial Reagents for Detection of Histoplasma Capsulatum Antigen in Urine. J Clin Microbiol. 2015;53(4):1198-203. PubMed PMID: 25631806.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Reevaluation of commercial reagents for detection of Histoplasma capsulatum antigen in urine. AU - Theel,Elitza S, AU - Harring,Julie A, AU - Dababneh,Ala S, AU - Rollins,Leonard O, AU - Bestrom,Jeannie E, AU - Jespersen,Deborah J, Y1 - 2015/01/28/ PY - 2015/1/30/entrez PY - 2015/1/30/pubmed PY - 2016/3/2/medline SP - 1198 EP - 203 JF - Journal of clinical microbiology JO - J Clin Microbiol VL - 53 IS - 4 N2 - Detection of the Histoplasma capsulatum urinary antigen (UAg) is among the most sensitive and rapid means to diagnose histoplasmosis. Previously, we evaluated analyte-specific reagents (ASR) manufactured by IMMY (Norman, OK) for detection of Histoplasma galactomannan (GM) in urine using an enzyme immunoassay (EIA), and we showed low positive agreement (64.5%) with the MiraVista (MVista) Histoplasma antigen (Ag) quantitative EIA (MiraVista Diagnostics, Indianapolis, IN). Here we reevaluated the IMMY GM ASR following modification of our original assay protocol and introduction of an indeterminate range. A total of 150 prospectively collected urine samples were tested with both the IMMY and MVista EIAs, and clinical histories were recorded for all study subjects. The IMMY GM ASR showed positive and negative agreements of 82.3% (14/17 samples) and 100% (121/121 samples), respectively (with exclusion of 12 indeterminate results), and overall agreement of 90% (135/150 samples) with respect to the MVista EIA. Of the three patients with negative IMMY GM ASR results and positive MVista EIA results, testing was performed for initial diagnostic purposes for one patient (<0.4 ng/ml by the MVista EIA) and UAg levels were being monitored for the remaining two patients (both<0.7 ng/ml by the MVista EIA). The MVista EIA results were positive for 6/12 samples that tested indeterminate by the IMMY GM ASR. We also show that the IMMY GM ASR can be used to serially monitor Histoplasma UAg levels. In conclusion, we demonstrate that, with modification, the IMMY GM ASR is a reliable rapid assay for detection of Histoplasma UAg. SN - 1098-660X UR - https://www.unboundmedicine.com/medline/citation/25631806/Reevaluation_of_commercial_reagents_for_detection_of_Histoplasma_capsulatum_antigen_in_urine_ L2 - http://jcm.asm.org/cgi/pmidlookup?view=long&amp;pmid=25631806 DB - PRIME DP - Unbound Medicine ER -