NCT02270697

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 32 (actual)
• Sponsor: National Cheng-Kung University Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Tinea Unguium
• Onychomycosis

Interventions

Type	Name	Description
DEVICE	Array	Applications of oligonucleotide array in diagnosis.

Timeline

• Start date: 2012-03-01
• Primary completion: 2013-03-01
• Completion: 2014-03-01
• First posted: 2014-10-21
• Last updated: 2014-10-21