In areas of low tuberculosis (TB) prevalence, laboratory diagnosis of TB may essentially cover non-tuberculous mycobacteria (NTM) in addition to Mycobacterium tuberculosis (MTB). In this study, a semi-automated PCR workflow distinguishing MTB and NTM (Anyplex™ MTB/NTMe, Seegene) and subsequently detecting MTB isoniazid/rifampicin resistance (Allplex™ MTB/MDRe, Seegene) was evaluated for replacing smear microscopy of acid-fast bacilli as the rapid screening method for TB. With 279 clinical samples, 47 cultures positive for MTB and 76 for NTM, the Anyplex™ MTB/NTMe assay and smear microscopy showed equal sensitivities (49.6% vs 50.8%, respectively) but Anyplex™ MTB/NTMe was more sensitive for MTB (63.8% vs 25.6%) than for NTM (40.8% vs 64.5%). Allplex™ MTB/MDRe showed a slightly higher sensitivity of 68.1% for MTB (32/47 positive, n = 222). Antibiotic resistance profiles were correctly identified for all MTB isolates (one MDR isolate). Specificity was 100% for both assays. Anyplex™ MTB/NTMe detected all the 18 NTM species present in the study. The analytical performance of the evaluated high-throughput workflow was relatively weak compared to culture but potentially adequate as a rapid screening method analogous to smear microscopy with additional differentiation between TB, MDR-TB, and NTM.

中文翻译：

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评估具有MTB，MDR和NTM检测的半自动化Seegene PCR工作流程，以在低患病情况下快速筛查结核病。

在结核病低发地区，除结核分枝杆菌（MTB）以外，结核病的实验室诊断可能基本上涵盖了非结核分枝杆菌（NTM）。在这项研究中，评估了区分MTB和NTM（Anyplex™MTB / NTMe，Seegene）并随后检测MTB异烟肼/利福平耐药性（Allplex™MTB / MDRe，Seegene）的半自动化PCR工作流程，以替代耐酸涂片显微镜细菌作为结核病的快速筛查方法。Anyplex™MTB / NTMe检测和涂片显微镜检查共279种临床样品，47种MTB阳性培养物和76种NTM阳性培养物，其敏感性相同（分别为49.6％和50.8％），但Anyplex™MTB / NTMe对MTB更为敏感（63.8 ％对比25.6％）比NTM（40.8％对比64.5％）。Allplex™MTB / MDRe对MTB的敏感性略高，为68.1％（32/47阳性，n = 222）。正确鉴定了所有MTB分离株（一种MDR分离株）的抗生素耐药性。两种测定的特异性均为100％。Anyplex™MTB / NTMe检测到研究中存在的所有18种NTM物种。与培养相比，评估的高通量工作流程的分析性能相对较弱，但作为类似于涂片显微镜的快速筛选方法（在TB，MDR-TB和NTM之间有额外的区别），可能足够。