Diagnostic microbiology and infectious disease · 2026
Evaluation of the Seegene NovaplexTM dermatophyte assay for diagnosis of onychomycosis.
СтатьяОценочное исследованиеНазвание и аннотация: Перевод в очереди
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Caza Mélissa, Tantichalermsin Cherie, Gonzales Sherry, Smith Laura, Wang Bing, Liao Robert, Yim Grace, Li Lisa, Wilmer Amanda
Аннотация
BACKGROUND: Onychomycosis is a fungal infection of the nails, which can cause significant psychosocial distress. Laboratory confirmation is recommended before initiating treatment.
OBJECTIVE: This study aimed to evaluate the performance of the Seegene NovaplexTM Dermatophyte assay for detecting dermatophyte infections in nail specimens, compared with culture and potassium hydroxide (KOH) smear.
METHODS: 149 nail samples submitted for culture and KOH testing were tested on the NovaplexTM Dermatophyte assay. A pre-treatment was developed to optimize the automation of DNA extraction from infected nails. Discrepant samples underwent ITS sequencing to establish a consensus result (agreement of ≥ 2 of 3 methods: culture, PCR, sequencing). Positive and negative percent agreement (PPA/NPA) were calculated versus culture, a composite reference (culture and/or KOH), and consensus. A nail infection model was developed to evaluate rarer clinical isolates. This model was used in analytical studies, including limit of detection (LoD), stability, and interference from topical products.
RESULTS: PPA and NPA for NovaplexTM assay exceeded 95% when compared with culture and composite reference. For Trichophyton rubrum complex, NPA increased from 73% versus culture to 96% versus composite reference and 93% versus consensus. The assay detected an additional 24 TRC and 4 Trichophyton mentagrophytes complex cases missed by culture. Against consensus, PPA and NPA exceeded 99%. Rare clinical isolates were correctly detected in 39/40 cases. Analytical studies confirmed manufacturer LoD, sample stability for up to 12 days, and no interference from topical treatments.
CONCLUSION: The NovaplexTM Dermatophyte assay provides a rapid, accurate, and reliable diagnostic tool for onychomycosis.
OBJECTIVE: This study aimed to evaluate the performance of the Seegene NovaplexTM Dermatophyte assay for detecting dermatophyte infections in nail specimens, compared with culture and potassium hydroxide (KOH) smear.
METHODS: 149 nail samples submitted for culture and KOH testing were tested on the NovaplexTM Dermatophyte assay. A pre-treatment was developed to optimize the automation of DNA extraction from infected nails. Discrepant samples underwent ITS sequencing to establish a consensus result (agreement of ≥ 2 of 3 methods: culture, PCR, sequencing). Positive and negative percent agreement (PPA/NPA) were calculated versus culture, a composite reference (culture and/or KOH), and consensus. A nail infection model was developed to evaluate rarer clinical isolates. This model was used in analytical studies, including limit of detection (LoD), stability, and interference from topical products.
RESULTS: PPA and NPA for NovaplexTM assay exceeded 95% when compared with culture and composite reference. For Trichophyton rubrum complex, NPA increased from 73% versus culture to 96% versus composite reference and 93% versus consensus. The assay detected an additional 24 TRC and 4 Trichophyton mentagrophytes complex cases missed by culture. Against consensus, PPA and NPA exceeded 99%. Rare clinical isolates were correctly detected in 39/40 cases. Analytical studies confirmed manufacturer LoD, sample stability for up to 12 days, and no interference from topical treatments.
CONCLUSION: The NovaplexTM Dermatophyte assay provides a rapid, accurate, and reliable diagnostic tool for onychomycosis.