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Multicenter Study
. 2016 May 6:6:25330.
doi: 10.1038/srep25330.

Rapid diagnosis of MDR and XDR tuberculosis with the MeltPro TB assay in China

Yu Pang  1 , Haiyan Dong  2 , Yaoju Tan  3 , Yunfeng Deng  4 , Xingshan Cai  3 , Hui Jing  4 , Hui Xia  1 , Qiang Li  1 , Xichao Ou  1 , Biyi Su  3 , Xuezheng Li  4 , Zhiying Zhang  2 , Junchen Li  2 , Jiankang Zhang  2 , Shitong Huan  5 , Yanlin Zhao  1
Affiliations
Multicenter Study

Rapid diagnosis of MDR and XDR tuberculosis with the MeltPro TB assay in China

Yu Pang et al. Sci Rep. .

Abstract

New diagnostic methods have provided a promising solution for rapid and reliable detection of drug-resistant TB strains. The aim of this study was to evaluate the performance of the MeltPro TB assay in identifying multidrug-resistant (MDR-) and extensively drug-resistant tuberculosis (XDR-TB) patients from sputum samples. The MeltPro TB assay was evaluated using sputum samples from 2057 smear-positive TB patients. Phenotypic Mycobacterial Growth Indicator Tube (MGIT) 960 drug susceptibility testing served as a reference standard. The sensitivity of the MeltPro TB assay was 94.2% for detecting resistance to rifampicin and 84.9% for detecting resistance to isoniazid. For second-line drugs, the assay showed a sensitivity of 83.3% for ofloxacin resistance, 75.0% for amikacin resistance, and 63.5% for kanamycin resistance. However, there was a significant difference for detecting kanamycin resistance between the two pilot sites in sensitivity, which was 53.2% in Guangdong and 81.5% in Shandong (P = 0.015). Overall, the MeltPro TB assay demonstrated good performance for the detection of MDR- and XDR-TB, with a sensitivity of 86.7% and 71.4%, respectively. The MeltPro TB assay is an excellent alternative for the detection of MDR- and XDR-TB cases in China, with high accuracy, short testing turn-around time, and low unit price compared with other tests.

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Figures

Figure 1
Figure 1. Flow diagram outlining patient enrollment and outcomes.
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