Central Tuberculosis Research Institute, Yauzskaya Alley, 2, 107564, Moscow, Russia.
Central Tuberculosis Research Institute, Yauzskaya Alley, 2, 107564, Moscow, Russia.
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%。
