New Diagnostic Strategy for Onychomycosis: First-Line Utilization of DermaGenius^® PCR and Calcofluor Microscopy...

Area of Science:

• Medical Mycology
• Molecular Diagnostics
• Infectious Diseases

Background:

• Onychomycosis (OM) is a common fungal nail infection necessitating accurate diagnosis before treatment.
• Current diagnostic methods like culture and PCR have limitations in sensitivity and scope.
• Prompt and precise diagnosis is crucial to avoid prolonged, ineffective antifungal therapies.

Purpose of the Study:

• To compare the diagnostic performance of conventional culture, multiplex PCR (DermaGenius® 2.0), and a novel mixed algorithm (MA).
• To evaluate the efficacy of the MA in improving diagnostic accuracy and efficiency for onychomycosis.

Main Methods:

• Conventional culture technique.
• Multiplex PCR (DermaGenius® 2.0).
• A mixed algorithm (MA) integrating PCR, direct examination with calcofluor (DEC), and selective culture.

Main Results:

• The MA demonstrated significantly higher sensitivity (98.18%) compared to PCR alone (78.18%) and culture alone (74.55%).
• MA achieved 100% specificity, comparable to PCR alone.
• Only 13% of samples required additional culture inoculation with the MA, indicating high efficiency.

Conclusions:

• The mixed algorithm represents a superior diagnostic strategy for onychomycosis.
• This approach enhances diagnostic accuracy, reduces turnaround time, and optimizes resource utilization.
• The MA effectively addresses the limitations of single-method diagnostic approaches for fungal nail infections.