synlab MVZ Gauting, IML red, WHO Supranational Reference Laboratory of Tuberculosis, Robert-Koch-Allee 2, 82131 Gauting, Germany.
BMC Infect Dis. 2014 Feb 5;14:59. doi: 10.1186/1471-2334-14-59.
With Fluorotype MTB (FT MTB, HAIN Lifesciences, Germany) a new semi-automated assay for detection of M. tuberculosis complex (MTBC) in clinical specimens has been introduced. In a prospective study, we evaluated the diagnostic performance of FT MTB in a routine diagnostic setting in a low-incidence country.
A total of 1039 respiratory specimens received for routine mycobacteriology diagnostics were analysed by FT MTB. Results were compared to those of culture, microscopy and clinical diagnosis. 61 specimens were excluded from further analysis due to bacterial contamination of cultures.
FT MTB detected 52 of 59 TB specimens (45 culture-positive with MTBC, 7 with clinical diagnosis of TB). With 902 of 912 non-TB specimens (884 culture-negative, 18 with growth of non-tuberculous mycobacteria) FT MTB was negative; discrepant positive FT MTB results were found with 10 specimens. Overall sensitivity, specificity, positive and negative predictive values were 88.1%, 98.9%, 83.8% and 99.2%. Sensitivity rates for smear-positive and smear-negative TB specimens were 100% and 56.3%, respectively. Seven of 978 samples (0.7%) yielded invalid FT MTB results.
FT MTB is a new accurate, half automated assay for rapidly diagnosing TB and suitable for larger series of samples. Performance characteristics were found to be similar to those of other commercial NAATs. Its sensitivity in paucibacillary, smear-negative specimens and its utility for TB diagnostics in high-incidence settings needs to be addressed in further studies.
Fluorotype MTB（FT MTB，德国海恩斯生命科学公司）是一种新的半自动化检测方法，用于检测临床标本中的结核分枝杆菌复合群（MTBC）。在一项前瞻性研究中，我们在低发病率国家的常规诊断环境中评估了 FT MTB 的诊断性能。
共分析了 1039 份用于常规分枝杆菌学诊断的呼吸道标本，FT MTB 的结果与培养、显微镜检查和临床诊断进行了比较。由于培养物的细菌污染，有 61 份标本被排除在进一步分析之外。
FT MTB 检测到 59 份 TB 标本中的 52 份（45 份培养阳性的 MTBC，7 份临床诊断为 TB）。912 份非 TB 标本中，FT MTB 为阴性（884 份培养阴性，18 份非结核分枝杆菌生长）；10 份标本的 FT MTB 结果不一致。总的敏感性、特异性、阳性和阴性预测值分别为 88.1%、98.9%、83.8%和 99.2%。涂片阳性和涂片阴性 TB 标本的敏感性分别为 100%和 56.3%。978 份样本中有 7 份（0.7%）FT MTB 结果无效。
FT MTB 是一种新的快速诊断 TB 的准确、半自动检测方法，适用于更大系列的样本。性能特征与其他商业 NAAT 相似。其在少菌、涂片阴性标本中的敏感性及其在高发病率环境中的 TB 诊断应用，需要在进一步的研究中加以解决。
