Onychomycosis Clinical Trial
Official title:
Evaluation of an Oligonucleotide Array for Rapid Identification of Dermatophytes in Clinical Specimens
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.
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.
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Time Perspective: Retrospective
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