Wang Hye-Young, Ahn Kwangjin, Uh Young, Lee Hyeyoung, Kim Seoyong, Chang Yunhee, Chang Chulhun L, Shim Tae-Sun
Optipharm, Inc., Wonju Eco Environmental Technology Center, Wonju-si, South Korea.
Department of Laboratory Medicine, Yonsei University Wonju College of Medicine, Wonju-si, South Korea.
Front Microbiol. 2018 Aug 17;9:1804. doi: 10.3389/fmicb.2018.01804. eCollection 2018.
Rapid and accurate detection of rifampin-resistant (MTB) is of primary importance for infection control and selection of anti-tuberculosis drugs. The aim of this study was to evaluate the usefulness of a newly developed multiplexed, bead-based bioassay (Quantamatrix Multiplexed Assay Platform, QMAP) for the direct detection of rifampin-resistant MTB in respiratory specimens. A total of 400 respiratory specimens collected from patients with clinically suspected tuberculosis or non-tuberculous mycobacteria (NTM) infections were tested with the culture-based conventional species identification and QMAP system. Among 400 specimens, 154 samples were evaluated using phenotypic anti-tuberculosis drug susceptibility test (DST) and the QMAP system for the detection of rifampin resistance. Detection agreement rate between the culture-based conventional identification and QMAP system for MTB and NTM according to acid-fast bacillus smear positivity was as follows: 97.0% (131/135) and 93.6% (88/94) in 229 smear-positive samples and 69.4% (25/36) and 73.0% (65/89) in 171 smear-negative samples. Based on culture as the gold standard, the overall sensitivity and specificity of the QMAP system for identification were 87.3 and 97.8%, respectively. The categorical agreement rate between phenotypic DST and QMAP system for rifampin was as follows: complete agreement, 92.9% (143/154); very major error, 0%; and major error, 0.6% (1/154). The overall sensitivity of the QMAP system for the detection of rifampin resistance was 97.1% (34/35). The QMAP system is a useful screening method for the early diagnosis of tuberculosis and selection of anti-tuberculosis drug, as it may detect rifampin-resistant MTB directly from respiratory specimens.
快速准确地检测耐利福平结核分枝杆菌（MTB）对于感染控制和抗结核药物的选择至关重要。本研究的目的是评估一种新开发的基于微珠的多重生物测定法（Quantamatrix多重测定平台，QMAP）用于直接检测呼吸道标本中耐利福平MTB的实用性。对从临床疑似结核病或非结核分枝杆菌（NTM）感染患者中收集的400份呼吸道标本进行了基于培养的传统菌种鉴定和QMAP系统检测。在400份标本中，154份样本使用表型抗结核药物敏感性试验（DST）和QMAP系统进行利福平耐药性检测。根据抗酸杆菌涂片阳性情况，基于培养的传统鉴定与QMAP系统对MTB和NTM的检测符合率如下：229份涂片阳性样本中分别为97.0%（131/135）和93.6%（88/94），171份涂片阴性样本中分别为69.4%（25/36）和73.0%（65/89）。以培养为金标准，QMAP系统鉴定的总体敏感性和特异性分别为87.3%和97.8%。表型DST与QMAP系统对利福平的分类符合率如下：完全符合，92.9%（143/154）；极重大错误，0%；重大错误，0.6%（1/154）。QMAP系统检测利福平耐药性的总体敏感性为97.1%（34/35）。QMAP系统是一种用于结核病早期诊断和抗结核药物选择的有用筛查方法，因为它可以直接从呼吸道标本中检测出耐利福平MTB。
