Monocentric evaluation of the Novaplex dermatophyte multiplex qPCR assay in the diagnosis of dermatophytoses.

IF 6.1 2区 医学 Q1 MICROBIOLOGY
Journal of Clinical Microbiology Pub Date : 2024-10-16 Epub Date: 2024-09-26 DOI:10.1128/jcm.00894-24
Florian Harel, Florence Robert-Gangneux, Jean-Pierre Gangneux, Hélène Guegan
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Abstract

Superficial fungal infections caused by dermatophytes are a prevalent global health concern. Rapid and accurate diagnosis of these pathogens through molecular tools would offer a substantial advantage for early detection and effective treatment. The conventional fungal culture presents inherent limitations, including extended result delivery delay and variable sensitivity. This study aimed to evaluate the performance of the multiplex real-time PCR Novaplex dermatophyte assay (Seegene) in comparison to traditional mycological methods including direct examination and culture. A total of 312 nail, skin, and scalp samples collected from patients with suspected superficial fungal infections for mycological diagnosis were retrospectively subjected to the Novaplex dermatophyte assay. Overall, 170 (54.6%) and 186 (59.6%) samples tested positive for dermatophyte culture and dermatophyte PCR, respectively. The concordance between PCR and culture for dermatophyte detection was 87.2%. There were 158 culture-positive/PCR-positive samples, 12 culture-positive/PCR-negative samples, and 28 culture-negative/PCR-positive samples. The sensitivity of PCR against culture varied according to the dermatophyte target, ranging from 90.5% (Trichophyton mentagrophytes/interdigitale/benhamiae), 91.2% (Trichophyton rubrum), to 100% (Microsporum spp. and Trichophyton tonsurans). When considering the final diagnosis using composite criteria, the sensitivity and specificity for the diagnosis of dermatophytosis were 92.9% and 96.6% for PCR, 86.7% and 100% for culture, and 95.4% and 92.2% for direct examination and culture combined, respectively. The Seegene Novaplex dermatophyte assay is an easy-to-use automated one-step extraction-PCR system that offers satisfactory performance for routine diagnosis of dermatophytoses in clinical laboratories, particularly in non-specialized centers. However, it cannot fully replace conventional mycology due to its inability to detect mold infections and to identify dermatophytes at the species level.

对 Novaplex 皮癣菌多重 qPCR 检测法诊断皮癣菌病的单中心评估。
由皮真菌引起的表皮真菌感染是全球普遍关注的健康问题。通过分子工具对这些病原体进行快速准确的诊断将为早期检测和有效治疗提供巨大优势。传统的真菌培养存在固有的局限性,包括结果传递延迟时间长、灵敏度不一。本研究旨在评估多重实时 PCR Novaplex 皮癣菌检测法(Seegene)与传统真菌学方法(包括直接检查和培养)的性能比较。我们对从疑似浅表真菌感染患者处采集的 312 份指甲、皮肤和头皮样本进行了回顾性分析。总体而言,分别有 170 份(54.6%)和 186 份(59.6%)样本的皮真菌培养和皮真菌 PCR 检测结果呈阳性。皮癣菌检测的 PCR 与培养的一致性为 87.2%。培养阳性/PCR 阳性的样本有 158 个,培养阳性/PCR 阴性的样本有 12 个,培养阴性/PCR 阳性的样本有 28 个。PCR 对培养的敏感性因目标皮癣菌而异,从 90.5%(门冬癣毛癣菌/interdigitale/benhamiae)、91.2%(红毛癣菌)到 100%(小孢子菌属和扁桃体毛癣菌)不等。在使用综合标准考虑最终诊断时,PCR 对皮癣病诊断的敏感性和特异性分别为 92.9% 和 96.6%,培养的敏感性和特异性分别为 86.7% 和 100%,直接检查和培养相结合的敏感性和特异性分别为 95.4% 和 92.2%。Seegene Novaplex皮癣菌检测法是一种易于使用的自动化一步提取-PCR系统,在临床实验室,尤其是非专业中心的皮癣菌常规诊断中表现令人满意。但是,由于它不能检测霉菌感染,也不能在物种水平上鉴定皮癣菌,因此不能完全取代传统的真菌学。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Journal of Clinical Microbiology
Journal of Clinical Microbiology 医学-微生物学
CiteScore
17.10
自引率
4.30%
发文量
347
审稿时长
3 months
期刊介绍: The Journal of Clinical Microbiology® disseminates the latest research concerning the laboratory diagnosis of human and animal infections, along with the laboratory's role in epidemiology and the management of infectious diseases.
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