Evaluation of enzyme-linked immunosorbent assays for detecting circulating antibodies to Candida albicans

Harry E Prince1, Cindy Yeh, Navid Alem

  • 1Focus Diagnostics, Inc. Cypress, California, USA.

Insights

This study validates a new Candida Detect ELISA system using cytoplasmic antigens for detecting systemic candidiasis. The assay shows excellent performance and reproducibility for IgG, IgM, and IgA antibodies, proving useful in clinical settings.

Area of Science:

  • Medical Diagnostics
  • Immunology
  • Microbiology

Background:

  • Systemic candidiasis diagnosis benefits from Candida albicans antibody assays.
  • Cytoplasmic antigens are more effective than cell wall components for these assays.

Purpose of the Study:

  • To evaluate the performance of a commercial Candida Detect ELISA system.
  • To assess the reliability and reproducibility of measuring C. albicans IgG, IgM, and IgA antibodies.

Main Methods:

  • Assessed intra-assay and inter-assay variation.
  • Evaluated specimen storage stability and inter-laboratory reproducibility.
  • Determined seroprevalence rates in different serum panels.

Main Results:

  • Assay showed low variation (<5% intra-assay, <10% inter-assay) and good linearity.
  • Excellent inter-laboratory reproducibility (>93% concordance).
  • Seroprevalence rates for IgG, IgM, and IgA were established, with similar rates in control and cross-reactive panels.

Conclusions:

  • The Candida Detect ELISA system demonstrates acceptable performance characteristics.
  • The assay is reliable for measuring C. albicans specific antibodies.
  • This system is a valuable tool for diagnosing systemic candidiasis.