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Evaluation of an enzyme immunoassay for detection of Histoplasma capsulatum antigen from urine specimens.
J Clin Microbiol. 2013 Nov; 51(11):3555-9.JC

Abstract

Detection of Histoplasma capsulatum urinary antigen (UAg) is important for the initial diagnosis of infection and for monitoring of patient responses to antifungal therapy. This study evaluated an analyte-specific reagent (ASR) enzyme immunoassay (EIA) for the detection of H. capsulatum UAg from Immuno Mycologics, Inc. (IMMY) (Norman, OK) in comparison with routine testing with the MiraVista (MVista) H. capsulatum quantitative EIA (MiraVista Diagnostics, Indianapolis, IN). Using prospectively collected urine specimens (n = 1,003), we observed an overall percent agreement between the two assays of 97.6% (979/1,003 samples). Compared with the MVista EIA, the sensitivity and specificity of the IMMY ASR EIA were 64.5% (40/62 samples) and 99.8% (939/941 samples), respectively, using a cutoff value of 0.5 ng/ml. Based on available clinical histories for 23/24 discordant samples, 5 IMMY assay-negative/MVista assay-positive samples were considered falsely positive. Furthermore, 10/23 discordant samples were positive by the MVista EIA but were below the limit of quantitation (<0.4 ng/ml). The clinical significance of these low positive results in the MVista EIA is unclear. In addition to the prospective study, we tested 11 urine specimens collected from patients with culture-confirmed Histoplasma infections, and 100% (11/11 samples) were positive by the IMMY ASR EIA. In conclusion, the IMMY ASR EIA may offer an alternative approach for the detection of Histoplasma UAg. Additional prospective studies are needed to better characterize the performance of the IMMY ASR EIA in conjunction with clinical and laboratory findings.

Authors+Show Affiliations

Division of Clinical Microbiology, Department of Laboratory Medicine and Pathology.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Evaluation Study
Journal Article

Language

eng

PubMed ID

23966508

Citation

Theel, Elitza S., et al. "Evaluation of an Enzyme Immunoassay for Detection of Histoplasma Capsulatum Antigen From Urine Specimens." Journal of Clinical Microbiology, vol. 51, no. 11, 2013, pp. 3555-9.
Theel ES, Jespersen DJ, Harring J, et al. Evaluation of an enzyme immunoassay for detection of Histoplasma capsulatum antigen from urine specimens. J Clin Microbiol. 2013;51(11):3555-9.
Theel, E. S., Jespersen, D. J., Harring, J., Mandrekar, J., & Binnicker, M. J. (2013). Evaluation of an enzyme immunoassay for detection of Histoplasma capsulatum antigen from urine specimens. Journal of Clinical Microbiology, 51(11), 3555-9. https://doi.org/10.1128/JCM.01868-13
Theel ES, et al. Evaluation of an Enzyme Immunoassay for Detection of Histoplasma Capsulatum Antigen From Urine Specimens. J Clin Microbiol. 2013;51(11):3555-9. PubMed PMID: 23966508.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Evaluation of an enzyme immunoassay for detection of Histoplasma capsulatum antigen from urine specimens. AU - Theel,Elitza S, AU - Jespersen,Deborah J, AU - Harring,Julie, AU - Mandrekar,Jay, AU - Binnicker,Matthew J, Y1 - 2013/08/21/ PY - 2013/8/23/entrez PY - 2013/8/24/pubmed PY - 2014/4/1/medline SP - 3555 EP - 9 JF - Journal of clinical microbiology JO - J Clin Microbiol VL - 51 IS - 11 N2 - Detection of Histoplasma capsulatum urinary antigen (UAg) is important for the initial diagnosis of infection and for monitoring of patient responses to antifungal therapy. This study evaluated an analyte-specific reagent (ASR) enzyme immunoassay (EIA) for the detection of H. capsulatum UAg from Immuno Mycologics, Inc. (IMMY) (Norman, OK) in comparison with routine testing with the MiraVista (MVista) H. capsulatum quantitative EIA (MiraVista Diagnostics, Indianapolis, IN). Using prospectively collected urine specimens (n = 1,003), we observed an overall percent agreement between the two assays of 97.6% (979/1,003 samples). Compared with the MVista EIA, the sensitivity and specificity of the IMMY ASR EIA were 64.5% (40/62 samples) and 99.8% (939/941 samples), respectively, using a cutoff value of 0.5 ng/ml. Based on available clinical histories for 23/24 discordant samples, 5 IMMY assay-negative/MVista assay-positive samples were considered falsely positive. Furthermore, 10/23 discordant samples were positive by the MVista EIA but were below the limit of quantitation (<0.4 ng/ml). The clinical significance of these low positive results in the MVista EIA is unclear. In addition to the prospective study, we tested 11 urine specimens collected from patients with culture-confirmed Histoplasma infections, and 100% (11/11 samples) were positive by the IMMY ASR EIA. In conclusion, the IMMY ASR EIA may offer an alternative approach for the detection of Histoplasma UAg. Additional prospective studies are needed to better characterize the performance of the IMMY ASR EIA in conjunction with clinical and laboratory findings. SN - 1098-660X UR - https://www.unboundmedicine.com/medline/citation/23966508/Evaluation_of_an_enzyme_immunoassay_for_detection_of_Histoplasma_capsulatum_antigen_from_urine_specimens_ L2 - http://jcm.asm.org/cgi/pmidlookup?view=long&amp;pmid=23966508 DB - PRIME DP - Unbound Medicine ER -