Evaluation of an Oligonucleotide Array for Rapid Identification of Dermatophytes in Clinical Specimens

Completed

• Conditions: Onychomycosis; Tinea Unguium
• Interventions: Device: Array

• Registration Number: NCT02270697
• Lead Sponsor: National Cheng-Kung University Hospital

Brief Summary

The nail specimens from patients with suspect onychomycosis were analyzed. Samples were collected as part of standard patient care from the Department of Dermatology, National Cheng Kung University Hospital (NCKUH, a tertiary referral hospital), Tainan, Taiwan. Comparing the array results with the regular methods by sensitivity, specificity, NPV and PPV.

Detailed Description

The nail specimens from patients with suspect onychomycosis were analyzed.

Collection:

Samples were collected as part of standard patient care from the Department of Dermatology, National Cheng Kung University Hospital (NCKUH, a tertiary referral hospital), Tainan, Taiwan.

Nail samples were collected as subungual scrapings, clippings, or curettings. Samples were immediately transported in sterile Eppendorf tubes at room temperature to the laboratory of Department of Dermatology, NCKUH, for KOH stain and routine fungal cultures.

Sample Prepare:

Each sample was cut into small pieces with a surgical blade and homogenization by 2-ml glass homogenizer. The suspension treated by lyticase at 37°C for 30 min and extracted DNA with Blood \& Tissue genomic DNA kit.PCR program and array hybirdization same with previous study.

Analysis:

If the results between array and culture method, discrepant analysis with re-sequencing, KOH mount and the patient's outcome of after antifungal treatment. The performance evaluation of the array and culture methods with Sensitivity, specificity, positive (PPV) and negative predictive value (NPV) were calculated after discrepant analysis. Significant difference was estimated by Fisher's exact test.

Study Timeline

• Study Start: 2012-03
• Primary Completion: 2013-03
• Study Completion: 2014-03
• Status Verified: 2014-10
• Study First Submitted: 2014-10-16
• Study First Submitted QC: 2014-10-17
• Last Update Submitted: 2014-10-17
• Study First Posted: 2014-10-21
• Last Update Posted: 2014-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Atypically results by culture and microscopy
• Suspect tinea infection

Exclusion Criteria

• Lost follow
• Not tinea unguium

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Regular Diagnosis	Array	Difficult in regular diagnosis specimens, assistance with array.

Primary Outcome Measures

Name	Time	Method
Oligonucleotide Array Detection Resluts	1 weeks	The species of pathogen provide by array method.