Evaluation of the MTBDRplus 2.0 assay for the detection of multidrug resistance among persons with presumptive pulmonary TB in China
Abstract We have conducted a multicenter study of the diagnostic accuracy of the MTBDRplus 2.0 assay in compared with conventional and molecular reference standard in four tuberculosis (TB)-specialized hospitals of China. A total of 5038 patients were enrolled in this study. The overall sensitivity...
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2017
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oai:doaj.org-article:4196e6fd5f93462486686f1c2b679cb52021-12-02T12:30:18ZEvaluation of the MTBDRplus 2.0 assay for the detection of multidrug resistance among persons with presumptive pulmonary TB in China10.1038/s41598-017-03473-72045-2322https://doaj.org/article/4196e6fd5f93462486686f1c2b679cb52017-06-01T00:00:00Zhttps://doi.org/10.1038/s41598-017-03473-7https://doaj.org/toc/2045-2322Abstract We have conducted a multicenter study of the diagnostic accuracy of the MTBDRplus 2.0 assay in compared with conventional and molecular reference standard in four tuberculosis (TB)-specialized hospitals of China. A total of 5038 patients were enrolled in this study. The overall sensitivity of the assay for the diagnosis of TB was 92.7% [1723/1858, 95% confidence interval (95% CI): 91.5–93.9]. In smear-positive/culture-positive cases the sensitivity was 97.7% (995/1018, 95% CI: 96.6–98.6), whereas in smear-negative/culture-positive cases it was 86.7% (728/840, 95% CI: 84.2–88.9). The agreement rate between MTBDRplus 2.0 and Xpert MTB/RIF was 97.7% (1015/1039, 95% CI: 96.6–98.5) for smear-positive cases and 97.0% (3682/3794, 95% CI: 96.5–97.6) for smear-negative cases. As compared with phenotypic drug susceptibility testing, the MTBDRplus 2.0 correctly identified 298 of 315 patients (94.6%, 95% CI: 91.5–96.8) with rifampicin-resistance. As noted previously, isoniazid resistance is associated with many different mutations and consequently the sensitivity compared to phenotypic testing was lower (81.0%, 95% CI: 76.8–84.7). In conclusion, this assay is a rapid, accurate test in terms of increased sensitivity for detecting smear-negative TB patients, as well as an alternative for detecting both RIF and INH resistance in persons with presumptive TB, whereas the absence of a mutation in the specimens must be interpreted cautiously.Yaoju TanQiang LiQing WangHuiping SunJin ChenXingshan CaiYinchai YaoXundi BaoChao WangYuan LiuXia WuYu PangYanlin ZhaoNature PortfolioarticleMedicineRScienceQENScientific Reports, Vol 7, Iss 1, Pp 1-6 (2017) |
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Medicine R Science Q Yaoju Tan Qiang Li Qing Wang Huiping Sun Jin Chen Xingshan Cai Yinchai Yao Xundi Bao Chao Wang Yuan Liu Xia Wu Yu Pang Yanlin Zhao Evaluation of the MTBDRplus 2.0 assay for the detection of multidrug resistance among persons with presumptive pulmonary TB in China |
| description |
Abstract We have conducted a multicenter study of the diagnostic accuracy of the MTBDRplus 2.0 assay in compared with conventional and molecular reference standard in four tuberculosis (TB)-specialized hospitals of China. A total of 5038 patients were enrolled in this study. The overall sensitivity of the assay for the diagnosis of TB was 92.7% [1723/1858, 95% confidence interval (95% CI): 91.5–93.9]. In smear-positive/culture-positive cases the sensitivity was 97.7% (995/1018, 95% CI: 96.6–98.6), whereas in smear-negative/culture-positive cases it was 86.7% (728/840, 95% CI: 84.2–88.9). The agreement rate between MTBDRplus 2.0 and Xpert MTB/RIF was 97.7% (1015/1039, 95% CI: 96.6–98.5) for smear-positive cases and 97.0% (3682/3794, 95% CI: 96.5–97.6) for smear-negative cases. As compared with phenotypic drug susceptibility testing, the MTBDRplus 2.0 correctly identified 298 of 315 patients (94.6%, 95% CI: 91.5–96.8) with rifampicin-resistance. As noted previously, isoniazid resistance is associated with many different mutations and consequently the sensitivity compared to phenotypic testing was lower (81.0%, 95% CI: 76.8–84.7). In conclusion, this assay is a rapid, accurate test in terms of increased sensitivity for detecting smear-negative TB patients, as well as an alternative for detecting both RIF and INH resistance in persons with presumptive TB, whereas the absence of a mutation in the specimens must be interpreted cautiously. |
| format |
article |
| author |
Yaoju Tan Qiang Li Qing Wang Huiping Sun Jin Chen Xingshan Cai Yinchai Yao Xundi Bao Chao Wang Yuan Liu Xia Wu Yu Pang Yanlin Zhao |
| author_facet |
Yaoju Tan Qiang Li Qing Wang Huiping Sun Jin Chen Xingshan Cai Yinchai Yao Xundi Bao Chao Wang Yuan Liu Xia Wu Yu Pang Yanlin Zhao |
| author_sort |
Yaoju Tan |
| title |
Evaluation of the MTBDRplus 2.0 assay for the detection of multidrug resistance among persons with presumptive pulmonary TB in China |
| title_short |
Evaluation of the MTBDRplus 2.0 assay for the detection of multidrug resistance among persons with presumptive pulmonary TB in China |
| title_full |
Evaluation of the MTBDRplus 2.0 assay for the detection of multidrug resistance among persons with presumptive pulmonary TB in China |
| title_fullStr |
Evaluation of the MTBDRplus 2.0 assay for the detection of multidrug resistance among persons with presumptive pulmonary TB in China |
| title_full_unstemmed |
Evaluation of the MTBDRplus 2.0 assay for the detection of multidrug resistance among persons with presumptive pulmonary TB in China |
| title_sort |
evaluation of the mtbdrplus 2.0 assay for the detection of multidrug resistance among persons with presumptive pulmonary tb in china |
| publisher |
Nature Portfolio |
| publishDate |
2017 |
| url |
https://doaj.org/article/4196e6fd5f93462486686f1c2b679cb5 |
| work_keys_str_mv |
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