Evaluation of Two Dermatophyte qPCR Kits on Skin and Keratinous Samples.

Evaluation of Two Dermatophyte qPCR Kits on Skin and Keratinous Samples

Superficial fungal infections (onychomycosis, dermatophytosis, tinea, etc.) caused by dermatophytes are common in the general population, affecting 20-25% worldwide (1, 2). In our practice, the most frequently observed clinical presentation is onychomycosis, with a prevalence ranging from 2% to 16.7% (3). However, diagnosing this fungal infection is challenging due to its lack of specificity and the long culture turnaround time (up to one month). A molecular approach could overcome these two limitations.

Currently, upon sample receipt, a direct mycological examination is performed alongside culture on specific media. If culture is positive, species or genus identification is carried out. Thus, the current reference method is a positive direct examination and/or a positive dermatophyte culture. Over the past four years (2020-2023), 49.85% of samples analyzed in our laboratory were positive (direct exam ± culture).

Several PCR kits are available for molecular detection of dermatophytes in skin and keratinous samples, and initial studies report promising performance: sensitivity ranging from 78.5% to 96.5% and specificity from 89.1% to 100%.

The study aims to determine the role of molecular diagnostics in these mycodermatological conditions and to compare the performance of two commercial kits.

Primary objective:

Determine the diagnostic performance of two molecular techniques for detecting dermatophytes.

The reference technique (gold standard) will be the presence of dermatophytes established by direct fungal examination. If the direct examination is negative, fungal culture will be performed for confirmation.

Secondary objectives:

Compare the diagnostic performance of the two molecular biology kits. Compare the average turnaround time for results.

Study Overview

• Status: Completed
• Conditions: Dermatophytosis
• Intervention / Treatment: Diagnostic test: PCR dermatophyte

• Study Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• France
  • Vandœuvre-lès-Nancy, France, 54500
    • CHRU Nancy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients consulting at CHRU Nancy for suspected dermatophyte infection.

Description

Inclusion Criteria:

• Patients consulting at CHRU Nancy for suspected dermatophyte infection.

Exclusion Criteria:

• out CHRU Nancy

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
dermatophytes : yes / no and species involved	1 month

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (Actual): December 27, 2024
• Primary Completion (Actual): November 1, 2025
• Study Completion (Actual): November 20, 2025

Study Registration Dates

• First Submitted: November 26, 2025
• First Submitted That Met QC Criteria: November 26, 2025
• First Posted (Estimated): December 8, 2025

Study Record Updates

• Last Update Posted (Estimated): December 9, 2025
• Last Update Submitted That Met QC Criteria: December 8, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Skin Diseases; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Mycoses; Dermatomycoses; Skin and Connective Tissue Diseases; Tinea
• Other Study ID Numbers: 2024-PI-081

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No