Wang Qian, Huang Xin, Yan Qiuhong, Chen Ruikang, Shao Lifang, Li Ruoyu, Song Yinggai, Yuan Xiaoying
Department of Dermatology, Taiyuan Central Hospital of Shanxi Medical University, Taiyuan, Shanxi, China.
Department of Dermatology, Air Force Medical Center, Fourth Military Medical University, Beijing, China.
Mycopathologia. 2024 Dec 30;190(1):6. doi: 10.1007/s11046-024-00921-7.
Traditional methods for diagnosing onychomycosis are characterized by limited sensitivity and prolonged processing times, and heavily rely on the skill level of laboratory personnel.
To develop a fast, simple, user-friendly, and reliable molecular assay that offers high sensitivity and specificity for the detection of common dermatophytes in nail specimens.
We developed a technique that integrates recombinase polymerase isothermal amplification with lateral flow dipstick (RPA-LFD) for the detection of pan-dermatophytes and Trichophyton rubrum, and evaluated its analytical sensitivity and specificity. This method was applied to analyze 190 nail specimens, with the results compared with traditional microscopy and fungal culture.
The RPA-LFD assay demonstrated an analytical sensitivity of 10 pg/reaction for pan-dermatophytes and 1 pg/reaction for T. rubrum. In clinical evaluations for tinea unguium, the sensitivity of the RPA-LFD, fungal culture, and microscopy methods, as determined through latent class analysis, was estimated to be 91.0%, 70.8%, and 93.9%, respectively. Correspondingly, the specificity of these methods-RPA-LFD, fungal culture, and microscopy-was assessed at approximately 95.7%, 98.0%, and 94.3%.
Our RPA-LFD assay exhibited high sensitivity and specificity in the detection of dermatophytes. Due to its technical simplicity, enhanced sensitivity, and reduced processing times, it represents a promising alternative to conventional fungal culture methods for the mycological detection and identification of dermatophytes.
传统的甲癣诊断方法灵敏度有限、处理时间长，且严重依赖实验室人员的技术水平。
开发一种快速、简单、用户友好且可靠的分子检测方法，用于检测指甲标本中的常见皮肤癣菌，具有高灵敏度和特异性。
我们开发了一种将重组酶聚合酶等温扩增与侧流试纸条（RPA-LFD）相结合的技术，用于检测泛皮肤癣菌和红色毛癣菌，并评估其分析灵敏度和特异性。该方法应用于分析190份指甲标本，结果与传统显微镜检查和真菌培养进行比较。
RPA-LFD检测方法对泛皮肤癣菌的分析灵敏度为10 pg/反应，对红色毛癣菌为1 pg/反应。在甲癣的临床评估中，通过潜在类别分析确定，RPA-LFD、真菌培养和显微镜检查方法的灵敏度分别估计为91.0%、70.8%和93.9%。相应地，这些方法（RPA-LFD、真菌培养和显微镜检查）的特异性分别约为95.7%、98.0%和94.3%。
我们的RPA-LFD检测方法在检测皮肤癣菌方面表现出高灵敏度和特异性。由于其技术简单、灵敏度提高且处理时间缩短，它是用于皮肤癣菌的真菌学检测和鉴定的传统真菌培养方法的一种有前景的替代方法。
