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External quality control of phenotypic drug susceptibility testing for Mycobacterium tuberculosis in China

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Abstract

The aim of our study was to evaluate the performance of conventional drug susceptibility testing (DST) among the tuberculosis (TB)-specialized hospitals in China. A total of 40 hospitals participated in the external quality assurance program for assessment of DST results from each hospital. The sensitivity, specificity, and accuracy of DST were analyzed. The mean accuracy was 96.5% for isoniazid (INH), 95.8% for rifampin (RIF), 97.0% for ethambutol (EMB), 96.8% for ofloxacin (OFX), 97.1% for kanamycin (KAN), 96.1% for amikacin (AMK), and 93.6% for capreomycin (CAP), respectively. Of the 40 participating laboratories, 4 (10.0%) and 6 (15%) failed to achieve 90% accuracy for INH and RIF, respectively. In addition, six hospitals (15%) were confirmed as certified to provide reliable DST results for both first-line and second-line drugs. The certified proportion for DST dropped from 73.9% in the non-western region to 59.2% in the western region. The significant difference was observed in the certified proportion for first-line drugs between the western and non-western region (P = 0.013). Our results demonstrate that the quality of phenotypical DST is frequently unsatisfactory, with approximately one-third of participated laboratories failing to produce certified phenotypical DST results. In addition, the uncertified laboratories majorly come from the western region in China.

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Acknowledgments

This study was supported by the Innovation Alliance on Tuberculosis Diagnosis and Treatment (Beijing). We would like to thank all the staffs participating in this study in the tuberculosis hospitals.

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Author notes

  1. Wei Shu, Jian Du and Yuhong Liu contributed equally to this work.

Authors and Affiliations

  1. Clinical Center on TB Control, Beijing Chest Hospital, Capital Medical University/Beijing Tuberculosis & Thoracic Tumor Research Institute, Beijing, 101149, People’s Republic of China

    Wei Shu, Jian Du, Yuhong Liu & Liang Li

  2. Department of Laboratory Quality Control, Innovation Alliance on Tuberculosis Diagnosis and Treatment (Beijing), Beijing, 101149, People’s Republic of China

    Wei Shu, Jian Du, Yuhong Liu, Yufeng Wang, Liang Li & Yu Pang

  3. National Clinical Laboratory on Tuberculosis, Beijing Chest Hospital, Capital Medical University/Beijing Tuberculosis & Thoracic Tumor Research Institute, Beijing, 101149, People’s Republic of China

    Fengmin Huo, Guanglu Jiang & Yu Pang

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  1. Wei Shu
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  2. Jian Du
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  3. Yuhong Liu
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  4. Yufeng Wang
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  5. Fengmin Huo
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  6. Guanglu Jiang
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  7. Liang Li
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  8. Yu Pang
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Correspondence to Liang Li or Yu Pang.

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Shu, W., Du, J., Liu, Y. et al. External quality control of phenotypic drug susceptibility testing for Mycobacterium tuberculosis in China. Eur J Clin Microbiol Infect Dis 39, 871–875 (2020). https://doi.org/10.1007/s10096-019-03770-1

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  • DOI: https://doi.org/10.1007/s10096-019-03770-1

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