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采用全基因组序列作为参考标准评估 GenoType NTM-DR 线探针杂交检测法对非结核分枝杆菌的检测。

Evaluation of the GenoType NTM-DR line probe assay for nontuberculous mycobacteria using whole genome sequences as reference standard.

机构信息

Center for Genes, Environment and Health, National Jewish Health, 1600 Jackson Street, Denver, CO, USA.

Center for Genes, Environment and Health, National Jewish Health, 1600 Jackson Street, Denver, CO, USA.

出版信息

Diagn Microbiol Infect Dis. 2024 Dec;110(4):116526. doi: 10.1016/j.diagmicrobio.2024.116526. Epub 2024 Sep 11.

DOI:10.1016/j.diagmicrobio.2024.116526
PMID:39293318
Abstract

Pulmonary nontuberculous mycobacteria (NTM) disease is an emerging public health challenge that is especially problematic in people with cystic fibrosis (CF). Effective treatment depends on accurate species and subspecies identification and antimicrobial susceptibility status. We evaluated the GenoType NTM-DR VER 1.0 assay using biobanked NTM isolates with whole genome sequence (WGS) data and control isolates (total n=285). Species and subspecies detection sensitivity and specificity were 100 % for all species and subspecies except for two subspecies of M. intracellulare, that demonstrated a small degree of discrepant identification between M. intracellulare subspecies intracellulare and subspecies chimaera. All antimicrobial resistance markers were identified with 100 % sensitivity and specificity. We conclude that the GenoType NTM-DR assay offers a rapid and accurate option for identifying the most frequently encountered pathogenic NTM taxa and drug resistance markers. SUPPORT: Colorado CF Research Development Program and Colorado CF National Resource Centers funded by the Cystic Fibrosis Foundation, NJH Advanced Diagnostics Laboratories, Colorado Advanced Industries Accelerator Grant.

摘要

肺非结核分枝杆菌(NTM)疾病是一个新出现的公共卫生挑战,尤其在囊性纤维化(CF)患者中更为严重。有效的治疗取决于准确的物种和亚种鉴定以及抗菌药物敏感性状态。我们使用具有全基因组序列(WGS)数据的生物银行 NTM 分离株和对照分离株(总共 n=285)评估了 GenoType NTM-DR VER 1.0 检测。除了两种细胞内分枝杆菌亚种,即细胞内分枝杆菌亚种 intracellulare 和亚种 chimera 之间存在一定程度的不一致鉴定外,该检测对所有物种和亚种的检测灵敏度和特异性均为 100%。所有抗菌药物耐药性标记均具有 100%的灵敏度和特异性。我们得出结论,GenoType NTM-DR 检测为鉴定最常见的致病性 NTM 分类群和耐药性标记提供了一种快速而准确的选择。支持:科罗拉多囊性纤维化研究开发计划和科罗拉多囊性纤维化国家资源中心由囊性纤维化基金会资助,NJH 高级诊断实验室,科罗拉多高级工业加速器赠款。

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