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

NCT ID: NCT02270697

Last Updated: 2014-10-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 32 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2014-03-31

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.

Conditions

Tinea Unguium; Onychomycosis

Study Design

• Study Time Perspective: RETROSPECTIVE

Study Groups

Regular Diagnosis

Difficult in regular diagnosis specimens, assistance with array.

Array

Intervention Type: DEVICE

Applications of oligonucleotide array in diagnosis.

Interventions

Array

Applications of oligonucleotide array in diagnosis.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Atypically results by culture and microscopy
• Suspect tinea infection

Exclusion Criteria

• Lost follow
• Not tinea unguium

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cheng-Kung University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Tsung Chain Chang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tsung Chain Chang, PhD

Role: PRINCIPAL_INVESTIGATOR

National Cheng Kung University

Other Identifiers

A-ER-101-336

Identifier Type: -

Identifier Source: org_study_id