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

Published studies indicate that Candida albicans antibody assays utilizing cytoplasmic antigens offer greater utility for identifying cases of systemic candidiasis when compared with assays utilizing cell wall components. We assessed the performance characteristics of a commercially available system that utilizes cytoplasmic antigens to measure C. albicans IgG, IgM, and IgA (Candida Detect ELISA reagents). Intra-assay variation was ≤5%, inter-assay variation was ≤10%, and good linearity was observed for all the three antibody isotypes. Results for specimens stored under various conditions were comparable to those obtained initially. Inter-laboratory reproducibility was excellent; qualitative concordance was ≥93% for all the three isotypes, with slopes and R2 values approaching 1.0 in linear regression analyses. Seroprevalence in persons without apparent systemic candidiasis was evaluated using three different serum panels; seroprevalence rates ranged from 24 to 32% for IgG, 2–14% for IgM, and 15–36% for IgA. Seroprevalence rates in a panel of sera containing antibodies to other fungi were similar to rates observed in panels from individuals without systemic candidiasis. These findings demonstrate the acceptable performance of assay systems employing Candida Detect ELISA reagents. J. Clin. Lab. Anal. 22:234–238, 2008. © 2008 Wiley-Liss, Inc.