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Multicenter feasibility study to assess external quality panels for molecular diagnostics for tuberculosis in China

European Journal of Clinical Microbiology & Infectious Diseases volume 39, pages 339–343 (2020)Cite this article

Abstract

The roll-out of molecular diagnostic tools continues to be the most important shift in the tuberculosis diagnostic landscape. The aim of this study was to develop a novel external quality assessment (EQA) panels for molecular TB diagnostics. In addition, we also assessed the performance of the laboratories with the EQA panels in China. Dried Mycobacterium tuberculosis (MTB) DNA in the chelex resin was designed as part of an EQA program. The storage of genomic DNA in the chelex resin layer had no effect on the stability of genomic DNA, even after 12 weeks of storage. Seventy-one laboratories have participated in EQA of molecular diagnostics for TB diagnosis in 2018. GeneXpert (74.6%, 53/71) was the most predominant molecular method, followed by GeneChip (32.3%, 23/71), MeltPro (22.5%, 16/71), and TB-LAMP (7.0%, 5/71). Out of 105 EQA panels, 103 EQA results (98.1%) achieved perfect scores, whereas the other two (1.9%) had satisfactory scores. There were a total of two false-negative results reported from two laboratories with local LAMP, respectively. In conclusion, we firstly develop feasible EQA panels for molecular diagnostics for tuberculosis in China. Our data demonstrate that a majority of participating laboratories are able to produce perfect results with molecular diagnostics in China, giving us important hints for the implementation of molecular diagnostics.

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

Affiliations

  1. Clinical Center on TB Control, 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

    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), 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, Beijing, 101149, People’s Republic of China

    Yu Pang

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  1. Jian Du
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  2. Wei Shu
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  3. Yuhong Liu
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  4. Yufeng Wang
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  5. Ying Zhan
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  6. Kexin Yu
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  7. Jingtao Gao
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  8. Liang Li
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  9. Yu Pang
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Correspondence to Liang Li or Yu Pang.

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Du, J., Shu, W., Liu, Y. et al. Multicenter feasibility study to assess external quality panels for molecular diagnostics for tuberculosis in China. Eur J Clin Microbiol Infect Dis 39, 339–343 (2020). https://doi.org/10.1007/s10096-019-03730-9

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  • DOI: https://doi.org/10.1007/s10096-019-03730-9

Keywords

  • Tuberculosis
  • External quality
  • Molecular diagnostics
  • China