Development and diagnostic evaluation of indirect enzyme linked immunosorbent assay for Epidermophyton floccosum infection in humans.

BACKGROUND: Epidermophyton floccosum is an anthrophophilic dermatophyte widely distributed in the tropics and subtropics. It can invade keratinized tissues of humans and cause superficial mycoses called dermatophytosis (ringworm).

OBJECTIVE: The main objective of this study was to develop an in-house indirect enzyme-linked immunosorbent assay (ELISA) and to evaluate its performance for the immunological diagnosis of E. floccosum infection in humans.

METHODS: An in-house indirect ELISA was developed using partially purified E. floccosum antigens, pre immunized rabbit serum as negative control, immunized rabbit polyclonal antibodies as positive control, enzyme labeled goat anti rabbit antibodies and goat anti human antibodies. A total of 50 serum samples from E. floccosum infected patients as confirmed by direct microscopy and culture and 30 samples from humans without history of dermatophyte infection that served as controls were used to evaluate the performance of an in-house indirect ELISA developed in this study. Analytical and diagnostic performance characteristics were determined to evaluate its diagnostic value.

RESULTS: The diagnostic sensitivity, specificity, positive and negative predictive values of E. floccosum indirect ELISA were 90.00 %, 83.33 %, 90.83 %, 83.83 % respectively. The performance of indirect ELISA assay was compared with gold standard diagnostic tests such as KOH hydrolysis test and fungal culture. The correlation coefficients of E. floccosum indirect ELISA with KOH hydrolysis and fungal culture method were 0.612** and 0.826** (P < 0.01) respectively indicating significant correlation between these tests.

CONCLUSION: This revealed the great potentiality of E. floccosum indirect ELISA in early, specific and precise detection of E. floccosum infection in humans.