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Development and validation of external quality assessment panels for mycobacterial culture testing to diagnose tuberculosis in China

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European Journal of Clinical Microbiology & Infectious Diseases Aims and scope Submit manuscript

Abstract

Mycobacterial culture remains the gold standard for detection of Mycobacterium tuberculosis (MTB) in clinical samples. However, no external quality assessment (EQA) tools exist to validate results obtained using this sophisticated method. Therefore, we developed EQA panels to assess the quality of mycobacterial culture results produced by designated TB hospitals in China. Artificial sputum containing methylcellulose was used to supplement quantified mycobacterial solutions to simulate culture-negative and culture-positive clinical sputum samples of low or high mycobacterial concentration, respectively. After storage of the quantified simulated EQA panels for 4 weeks at 4 °C, experimental bacterial quantification of the panels was again conducted, with no impact of artificial sputum on mycobacterial culture results observed. Next, 47 tuberculosis (TB) hospitals were recruited for evaluation of the EQA panels. Overall, 29 hospitals (61.7%) produced mycobacterial culture test results matching expected results for the EQA panels, while the remaining 18 (38.3%) hospitals did not. False-negative results for the low mycobacterial concentration panel sample accounted for 33 (73.3%) diagnostic errors. Compared with hospitals using solid culture methods as a control group, hospitals using the liquid culture method were less likely to produce uncertified results (aOR 0.064, 95% CI 0.005–0.770). In conclusion, we first developed then evaluated EQA panels for validation of mycobacterial culture testing in China. Our data demonstrate that approximately one-third of TB hospitals failed to produce results that met criteria for classification as certified mycobacterial culture testing providers, emphasizing the importance of quality control and quality assurance in TB diagnostics.

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Acknowledgments

We would like to thank all the staffs participating in this study in the tuberculosis hospitals.

Support statement

This study was funded by the Foundation from the Innovation Alliance on Tuberculosis Diagnosis and Treatment (Beijing).

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Author notes

  1. Jian Du, Wei Shu 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

    Jian Du, Wei Shu, Yuhong Liu, Jingtao Gao, Liang Li & Yu Pang

  2. Department of Laboratory Quality Control, Innovation Alliance on Tuberculosis Diagnosis and Treatment (Beijing), No 9, Beiguan Street, Tongzhou District, Beijing, 101149, People’s Republic of China

    Jian Du, Wei Shu, Yuhong Liu, Yufeng Wang, Ying Zhan, Kexin Yu, Jingtao Gao, Liang Li & Yu Pang

  3. National Clinical Laboratory on Tuberculosis, Beijing Chest Hospital, Capital Medical University/Beijing Tuberculosis & Thoracic Tumor Research Institute, No 9, Beiguan Street, Tongzhou District, Beijing, 101149, People’s Republic of China

    Yu Pang

Authors
  1. Jian Du
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  2. Wei Shu
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Contributions

J. Du, Y. Wang, L. Li, and Y. Pang participated in the development of external quality control panels. W. Shu, Y. Liu, Y. Zhan, K. Yu, J. Gao, L. Liang, and Y. Pang analyzed and interpreted the data. Y. Pang and L. Li wrote the first draft of this report. All authors gave input to the final version. Y. Pang and L. Li had the final responsibility for the decision to submit the study for publication.

Corresponding authors

Correspondence to Liang Li or Yu Pang.

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The authors declare that they have no conflict of interest.

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Main point

We first developed then evaluated EQA panels for validation of mycobacterial culture testing in China. Approximately one-third of TB hospitals failed to produce results that met criteria for classification as certified mycobacterial culture testing providers.

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Du, J., Shu, W., Liu, Y. et al. Development and validation of external quality assessment panels for mycobacterial culture testing to diagnose tuberculosis in China. Eur J Clin Microbiol Infect Dis 38, 1961–1968 (2019). https://doi.org/10.1007/s10096-019-03634-8

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  • DOI: https://doi.org/10.1007/s10096-019-03634-8

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