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一种新型商用多重 PCR 诊断检测方法用于皮肤真菌病鉴别诊断的临床评估。

Clinical evaluation of a novel commercial multiplex-based PCR diagnostic test for differential diagnosis of dermatomycoses.

机构信息

Department of Dermatology, University Hospital Carl Gustav Carus, TU Dresden, Dresden, Germany.

出版信息

Mycoses. 2014 Jan;57(1):27-34. doi: 10.1111/myc.12097. Epub 2013 Jun 4.

DOI:10.1111/myc.12097
PMID:23734586
Abstract

Dermatomycoses are very common worldwide with increasing prevalence. An accurate and rapid detection of fungi is most important for the choice of antimycotics and the success of treatment. The aim of this study was to evaluate a new commercial multiplex-based PCR which allows the detection and differentiation of the most relevant human pathogen fungi causing dermatomycoses in Europe. The accuracy and reproducibility of this application were verified in a clinical performance assessment in comparison to direct microscopy and culture using DNA isolates from 253 clinical samples. Sensitivity, specificity, positive predictive value and negative predictive value of 87.3%, 94.3%, 87.3% and 94.3%, respectively, were calculated for dermatophytes when confirmed by direct microscopy, culture or both. The corresponding values for Candida spp. were 62.7%, 93.5%, 77.8%, and 87.4%, respectively. Furthermore, in comparison to culture, the multiplex PCR was able to detect additional 38 Trichophytum rubrum and 12 Trichophytum interdigitale infections. These results were confirmed by independent PCR analysis. From DNA isolation to diagnosis the multiparameter diagnostic kit gives rise to a 1-day workflow, enables fast clarification of disease aetiology and, thus, contributes to specific therapy selection. The latter is particularly important in light of growing resistance to antimycotics.

摘要

皮肤真菌病在全球范围内非常普遍,且患病率呈上升趋势。准确、快速地检测真菌对于选择抗真菌药物和治疗成功至关重要。本研究旨在评估一种新的商业多重 PCR,该方法可检测和区分在欧洲引起皮肤真菌病的最相关的人类病原体真菌。在与直接显微镜检查和培养相比的临床性能评估中,通过 253 个临床样本的 DNA 分离物验证了该应用的准确性和重现性。当通过直接显微镜检查、培养或两者结合确认时,皮肤癣菌的敏感性、特异性、阳性预测值和阴性预测值分别为 87.3%、94.3%、87.3%和 94.3%。对于假丝酵母菌属,相应的值分别为 62.7%、93.5%、77.8%和 87.4%。此外,与培养相比,多重 PCR 还能够检测到额外的 38 株红色毛癣菌和 12 株须癣毛癣菌感染。这些结果通过独立的 PCR 分析得到了证实。从 DNA 提取到诊断,多参数诊断试剂盒可在 1 天内完成工作流程,快速阐明病因,从而有助于选择特异性治疗。鉴于抗真菌药物的耐药性不断增加,后者尤为重要。

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