评价一种新的检测方法在诊断材料和培养物中非结核分枝杆菌种的鉴定。
Evaluation of a new assay for nontuberculous mycobacteria species identification in diagnostic material and cultures.
机构信息
Central Tuberculosis Research Institute, Yauzskaya Alley, 2, 107564, Moscow, Russia.
Central Tuberculosis Research Institute, Yauzskaya Alley, 2, 107564, Moscow, Russia.
出版信息
Tuberculosis (Edinb). 2021 Sep;130:102124. doi: 10.1016/j.tube.2021.102124. Epub 2021 Sep 3.
The purpose of the present study was to evaluate a real-time PCR system for 12 nontuberculous mycobacteria (NTM) species identification developed by Central Tuberculosis Research Institute (CTRI; Moscow, Russia) in cooperation with Syntol LLC (Moscow, Russia). NTM cultures (210 strains, 19 species), Mycobacterium tuberculosis complex (MTBC) cultures (21 strains, 2 species), non-mycobacterial microorganisms (18 strains, 13 species) were used for the first stage of the assay evaluation. Clinical samples (sputum, N = 973) positive for smear microscopy and MTBC/NTM DNA by a PCR-based screening assay collected from 819 patients were used for specificity and sensitivity evaluation. Sensitivity for determining the NTM species directly from diagnostic material was 99.71%, with the specificity of 100%. The sensitivity and specificity for NTM species identification in cultures was 99.67% and 100%, respectively. Both sensitivity and specificity for determining MTBC in cultures was 100%.
本研究的目的是评估由俄罗斯中央结核病研究所（CTRI；莫斯科）与俄罗斯莫斯科 Syntol 有限责任公司合作开发的用于鉴定 12 种非结核分枝杆菌（NTM）的实时 PCR 系统。该系统评估的第一阶段使用了 NTM 培养物（210 株，19 种）、结核分枝杆菌复合群（MTBC）培养物（21 株，2 种）和非分枝杆菌微生物（18 株，13 种）。从 819 名患者中收集的用于涂片显微镜检查和基于 PCR 的筛查检测呈阳性的临床样本（痰，N=973）用于特异性和敏感性评估。直接从诊断材料中鉴定 NTM 种的敏感性为 99.71%，特异性为 100%。培养物中鉴定 NTM 种的敏感性和特异性分别为 99.67%和 100%。培养物中鉴定 MTBC 的敏感性和特异性均为 100%。
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