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

N

National Cheng-Kung University

Status

Completed

Conditions

Tinea Unguium
Onychomycosis

Treatments

Device: Array

Study type

Observational

Funder types

Other

Identifiers

NCT02270697
A-ER-101-336

Details and patient eligibility

About

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.

Full 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.

Enrollment

32 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Atypically results by culture and microscopy
  • Suspect tinea infection

Exclusion criteria

  • Lost follow
  • Not tinea unguium

Trial design

32 participants in 1 patient group

Regular Diagnosis
Description:
Difficult in regular diagnosis specimens, assistance with array.
Treatment:
Device: Array

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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