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中央结核病研究所（CTRI；俄罗斯莫斯科）与 Syntol LLC（俄罗斯莫斯科）合作开发的用于 12 种非结核分枝杆菌 (NTM) 物种鉴定的实时 PCR 系统。NTM 培养物（210 株，19 种），结核分枝杆菌复合 (MTBC) 培养物（21 株，2 种）、非分枝杆菌微生物（18 株，13 种）用于测定评估的第一阶段。通过从 819 名患者收集的基于 PCR 的筛选试验，涂片镜检和 MTBC/NTM DNA 呈阳性的临床样本（痰，N = 973）用于特异性和敏感性评估。直接从诊断材料中确定 NTM 种类的敏感性为 99.71%，特异性为 100%。培养物中 NTM 物种鉴定的敏感性和特异性分别为 99.67% 和 100%。在培养物中测定 MTBC 的敏感性和特异性均为 100%。