Advancing Dermatomycosis Diagnosis: Evaluating a Microarray-Based Platform for Rapid and Accurate Fungal Detection-A Pilot Study.

Abstract

Dermatomycosis, including the most prevalent onychomycosis, significantly impacts patients' quality of life due to its chronic nature and high recurrence rate. Conventional diagnostic methods are often limited by low sensitivity and specificity and prolonged turnaround times. This study evaluates the EUROArray Dermatomycosis Platform, a microarray-based molecular assay, for its performance in identifying fungi causing dermatomycosis. Forty reference fungal strains, covering on-panel and off-panel species, and 120 clinical samples from patients with suspected dermatomycosis were analyzed. The platform's accuracy was compared to microscopy and/or culture as the diagnostic standard. The assay demonstrated 100% analytical sensitivity and 97.1% analytical specificity, correctly identifying 33 of 34 fungal species while misclassifying one. In clinical samples, the assay showed good sensitivity (78.6%) and high specificity (91.7%), detecting additional positive cases missed by culture, which highlights the assay's ability to identify non-viable fungi and low fungal loads. The assay achieved a positive predictive value of 75.9% and a negative predictive value of 92.8%, reinforcing its diagnostic reliability. Despite some discordances, the assay provides rapid results and broad-spectrum fungal detection, positioning it as a valuable complement to conventional diagnostics. Future improvements, including expanding the identification panel and optimizing sample handling, could further enhance its clinical utility.