Tags

Type your tag names separated by a space and hit enter

Evaluation of commercially available reagents for diagnosis of histoplasmosis infection in immunocompromised patients.
J Clin Microbiol. 2013 Dec; 51(12):4095-101.JC

Abstract

Urinary histoplasma antigen measurement can be useful for diagnosing systemic histoplasmosis and for monitoring treatment response, especially in immunocompromised patients. However, testing has traditionally been limited to specialized reference laboratories, as immunoassay reagents for the antigen were not widely available. Recently, a polyclonal-antibody-based in vitro diagnostic (IVD) kit for histoplasma antigen detection was released, as well as monoclonal-antibody reagents against the target. We evaluated the analytical and clinical performance of the two reagents. Both assays were capable of detecting histoplasma antigen in urine samples over a wide dynamic range, although the monoclonal assay showed improved precision and analytical sensitivity relative to the polyclonal IVD. In a test set of clinically characterized patient samples, the monoclonal laboratory-developed test (LDT) demonstrated 90.5% sensitivity and 96.3% specificity versus 61.9% sensitivity and 79.3% specificity for the polyclonal IVD, with areas under the curve (AUCs) of 0.987 and 0.754, respectively. The major differences between the two assays were higher background reactivity in healthy donors with the polyclonal assay and an increased signal response in positive samples for the monoclonal assay. The impact of these differences on monitoring treatment response was evaluated in a series of patients undergoing treatment for histoplasmosis. While all the assays gave similar qualitative estimates of treatment response, responses were more evident using the monoclonal assay. In summary, we conclude that while multiple assays are available for measuring histoplasma antigen in urine, a monoclonal-antibody-based assay appears to provide improved analytical performance for management of immunocompromised histoplasmosis patients.

Authors+Show Affiliations

Pathology and Laboratory Medicine Institute, Cleveland Clinic, Cleveland, Ohio, USA.No affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Evaluation Study
Journal Article

Language

eng

PubMed ID

24088857

Citation

Zhang, Xiaochun, et al. "Evaluation of Commercially Available Reagents for Diagnosis of Histoplasmosis Infection in Immunocompromised Patients." Journal of Clinical Microbiology, vol. 51, no. 12, 2013, pp. 4095-101.
Zhang X, Gibson B, Daly TM. Evaluation of commercially available reagents for diagnosis of histoplasmosis infection in immunocompromised patients. J Clin Microbiol. 2013;51(12):4095-101.
Zhang, X., Gibson, B., & Daly, T. M. (2013). Evaluation of commercially available reagents for diagnosis of histoplasmosis infection in immunocompromised patients. Journal of Clinical Microbiology, 51(12), 4095-101. https://doi.org/10.1128/JCM.02298-13
Zhang X, Gibson B, Daly TM. Evaluation of Commercially Available Reagents for Diagnosis of Histoplasmosis Infection in Immunocompromised Patients. J Clin Microbiol. 2013;51(12):4095-101. PubMed PMID: 24088857.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Evaluation of commercially available reagents for diagnosis of histoplasmosis infection in immunocompromised patients. AU - Zhang,Xiaochun, AU - Gibson,Bill,Jr AU - Daly,Thomas M, Y1 - 2013/10/02/ PY - 2013/10/4/entrez PY - 2013/10/4/pubmed PY - 2014/6/24/medline SP - 4095 EP - 101 JF - Journal of clinical microbiology JO - J Clin Microbiol VL - 51 IS - 12 N2 - Urinary histoplasma antigen measurement can be useful for diagnosing systemic histoplasmosis and for monitoring treatment response, especially in immunocompromised patients. However, testing has traditionally been limited to specialized reference laboratories, as immunoassay reagents for the antigen were not widely available. Recently, a polyclonal-antibody-based in vitro diagnostic (IVD) kit for histoplasma antigen detection was released, as well as monoclonal-antibody reagents against the target. We evaluated the analytical and clinical performance of the two reagents. Both assays were capable of detecting histoplasma antigen in urine samples over a wide dynamic range, although the monoclonal assay showed improved precision and analytical sensitivity relative to the polyclonal IVD. In a test set of clinically characterized patient samples, the monoclonal laboratory-developed test (LDT) demonstrated 90.5% sensitivity and 96.3% specificity versus 61.9% sensitivity and 79.3% specificity for the polyclonal IVD, with areas under the curve (AUCs) of 0.987 and 0.754, respectively. The major differences between the two assays were higher background reactivity in healthy donors with the polyclonal assay and an increased signal response in positive samples for the monoclonal assay. The impact of these differences on monitoring treatment response was evaluated in a series of patients undergoing treatment for histoplasmosis. While all the assays gave similar qualitative estimates of treatment response, responses were more evident using the monoclonal assay. In summary, we conclude that while multiple assays are available for measuring histoplasma antigen in urine, a monoclonal-antibody-based assay appears to provide improved analytical performance for management of immunocompromised histoplasmosis patients. SN - 1098-660X UR - https://www.unboundmedicine.com/medline/citation/24088857/Evaluation_of_commercially_available_reagents_for_diagnosis_of_histoplasmosis_infection_in_immunocompromised_patients_ L2 - http://jcm.asm.org/cgi/pmidlookup?view=long&pmid=24088857 DB - PRIME DP - Unbound Medicine ER -