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Comparison of the diagnostic efficacy of the CapitalBio Mycobacterium real-time polymerase chain reaction detection test and Xpert MTB/RIF in smear-negative pulmonary tuberculosis

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Abstract

To compare the diagnostic efficacy of CapitalBio Mycobacterium real-time polymerase chain reaction (RT-PCR) detection test and the first-generation Xpert MTB/RIF in smear-negative pulmonary tuberculosis (PTB). In this retrospective study of smear-negative PTB, we reviewed patient medical records to determine the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and area under the curve (AUC) of Xpert MTB/RIF, CapitalBio Mycobacterium detection test, and the parallel test (positive result for either of the Xpert MTB/RIF and CapitalBio Mycobacterium detection tests) to evaluate their diagnostic accuracy against a composite reference standard. In total, 1553 patients were evaluated. The sensitivity, specificity, PPV, NPV, and AUC of Xpert MTB/RIF, CapitalBio Mycobacterium detection test, and the parallel test were 57.1%, 92.9%, 81.1%, 95.9%, and 0.75; 53.4%, 97.7%, 98.6%, 41.5%, and 0.76; and 66.2%, 90.8%, 95.5%, 47.7%, and 0.79, respectively. For the bronchoalveolar lavage fluid (BALF) specimens, these values for Xpert MTB/RIF, CapitalBio Mycobacterium detection test, and the parallel test were 68.8%, 97.7%, 99.2%, 43.9%, and 0.83; 61.7%, 97.7%, 99.1%, 38.9%, and 0.80; and 77.0%, 95.5%, 98.6%, 50.9%, and 0.86, respectively. CapitalBio Mycobacterium detection test had moderate accuracy for smear-negative PTB, similar to Xpert MTB/RIF. The parallel test improved the sensitivity. BALF significantly improved the sensitivity and diagnostic accuracy of the test. The maximum diagnostic accuracy for smear-negative PTB was obtained with the parallel test and BALF specimens. BALF was the most effective specimen for diagnosing smear-negative PTB.

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Acknowledgments

We would like to express our feelings to the patients and colleagues in our department.

Funding

The study was supported by Zhejiang Administration of Traditional Chinese Medicine, http://www.zjtcm.gov.cn. Fangming Zhong, 2019ZB095.

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Author notes

  1. Hong Zheng and Fangming Zhong contributed equally to this work.

Authors and Affiliations

  1. Zhejiang Tuberculosis Diagnosis and Treatment Center, Zhejiang Chinese Medicine and Western Medicine Integrated Hospital, Hangzhou, Zhejiang, China

    Hong Zheng, Fangming Zhong, Guocan Yu & Yanqin Shen

Authors
  1. Hong Zheng
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  2. Fangming Zhong
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  3. Guocan Yu
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Contributions

Hong Zheng: Data collection, software, data curation, data analysis, writing—original draft

Fangming Zhong: Data collection, software, data analysis, funding acquisition, formal analysis

Guocan Yu: Data analysis, supervision, writing—original draft

Yanqin Shen: Study design, methodology, writing—review and editing

Corresponding author

Correspondence to Yanqin Shen.

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All patients gave written informed consent and the study was approved by the Human Research Ethics Committee of Zhejiang Chinese Medicine and Western Medicine Integrated Hospital.

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Zheng, H., Zhong, F., Yu, G. et al. Comparison of the diagnostic efficacy of the CapitalBio Mycobacterium real-time polymerase chain reaction detection test and Xpert MTB/RIF in smear-negative pulmonary tuberculosis. Eur J Clin Microbiol Infect Dis 40, 969–977 (2021). https://doi.org/10.1007/s10096-020-04113-1

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  • DOI: https://doi.org/10.1007/s10096-020-04113-1

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