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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02270697
Enrollment
32
Registered
2014-10-21
Start date
2012-03-31
Completion date
2014-03-31
Last updated
2014-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Onychomycosis, Tinea Unguium

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.

Interventions

DEVICEArray

Applications of oligonucleotide array in diagnosis.

Sponsors

National Cheng-Kung University Hospital
Lead SponsorOTHER

Study design

Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Atypically results by culture and microscopy * Suspect tinea infection

Exclusion criteria

* Lost follow * Not tinea unguium

Design outcomes

Primary

MeasureTime frameDescription
Oligonucleotide Array Detection Resluts1 weeksThe species of pathogen provide by array method.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026