Development and evaluation of an enzyme-linked immunosorbent assay to detect Histoplasma capsulatum antigenuria in

Christina M Scheel1, Blanca Samayoa, Alejandro Herrera

  • 1Division of Foodborne, Bacterial and Mycotic Diseases, Centers for Disease Control and Prevention, 1600 Clifton Rd. NE, Mailstop G-11, Atlanta, GA 30333, USA. cscheel@cdc.gov

Insights

A new enzyme-linked immunosorbent assay (ELISA) detects Histoplasma capsulatum antigen in urine, aiding rapid diagnosis of progressive disseminated histoplasmosis (PDH) in HIV-infected individuals, especially in resource-limited settings.

Area of Science:

  • Mycology
  • Infectious Diseases
  • Immunology

Background:

  • Histoplasma capsulatum infection causes severe illness and death in individuals with HIV/AIDS, particularly in regions with limited diagnostic and treatment access.
  • Progressive disseminated histoplasmosis (PDH) can rapidly become fatal if not diagnosed and treated promptly.
  • There is a critical need for simple, rapid diagnostic tools for H. capsulatum infection in resource-limited endemic areas.

Purpose of the Study:

  • To develop and evaluate a rapid antigen-capture enzyme-linked immunosorbent assay (ELISA) for detecting H. capsulatum antigenuria.
  • To provide a tool for early diagnosis of PDH in settings with limited resources.

Main Methods:

  • Development of a polyclonal antibody-based antigen-capture ELISA to detect H. capsulatum antigen in urine.
  • Inclusion of a standard reference curve for quantitative antigenuria measurement and assay reproducibility.
  • Evaluation of the ELISA using urine samples from patients with AIDS and histoplasmosis (n=48), healthy individuals (n=83), and patients with other diseases (n=114) in Guatemala.

Main Results:

  • The developed ELISA demonstrated a sensitivity of 81% and a specificity of 95% for detecting H. capsulatum antigen in urine.
  • The assay utilizes simple technology suitable for resource-limited healthcare facilities.

Conclusions:

  • The antigen-capture ELISA is a promising tool for the rapid diagnosis of PDH in HIV-infected individuals in endemic countries.
  • This assay can expedite treatment initiation, potentially reducing PDH-related mortality in areas with high incidence and limited healthcare infrastructure.