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Objective <p>To evaluate the diagnostic performance of the Cepheid 3-gene Host Response Test (Xpert-MTB-HR) for tuberculosis disease (TBD). </p> Methods <p>Among 1,128 participants enrolled in this study, 740 were diagnosed with TBD, and the remaining 388 were classified as Non-TB participants, including 218 cases of other pulmonary diseases (OPD), 48 cases of TB infection (TBI), and 122 healthy controls (HC). TB scores were obtained for all participants using the Xpert-MTB-HR assay, and diagnostic performance was evaluated by ROC curves and AUC.</p> Results <p>The corresponding AUCs of the TB score for distinguishing TBD from non-TB, HC, OPD, and TBI were 0.717 (95% CI, 0.686-0.748; sensitivity 63.6%, specificity 72.7%), 0.846 (95% CI, 0.814-0.878; sensitivity 70.9%, specificity 88.5%), 0.625 (95% CI, 0.583-0.667; sensitivity 54.9%, specificity 67.9%), and 0.807 (95% CI, 0.761-0.853; sensitivity 60.6%, specificity 93.8%), respectively. TB scores were negatively correlated with bacterial load and C-reactive protein levels (both p &lt; 0.001). Differences in TB scores were observed across treatment duration groups in this cross-sectional analysis.</p> Conclusion <p>Xpert MTB-HR did not fully meet WHO performance targets in the overall population, with performance influenced by pathogen load, particularly in low bacterial load or post-treatment patients. TB score showed patterns consistent with treatment response, warranting longitudinal validation.</p> Clinical trial <p>Not applicable.</p>

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Blood-based cepheid 3-gene host response test for TB disease: diagnostic performance at a specialized respiratory hospital in China

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年2月4日

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  • Miaomiao Zhao,
  • Yanyang Zhou,
  • Hui Chen,
  • Lina Huang,
  • Tingting Chen,
  • Lulu Xu,
  • Ping Xu

摘要

Objective

To evaluate the diagnostic performance of the Cepheid 3-gene Host Response Test (Xpert-MTB-HR) for tuberculosis disease (TBD).

Methods

Among 1,128 participants enrolled in this study, 740 were diagnosed with TBD, and the remaining 388 were classified as Non-TB participants, including 218 cases of other pulmonary diseases (OPD), 48 cases of TB infection (TBI), and 122 healthy controls (HC). TB scores were obtained for all participants using the Xpert-MTB-HR assay, and diagnostic performance was evaluated by ROC curves and AUC.

Results

The corresponding AUCs of the TB score for distinguishing TBD from non-TB, HC, OPD, and TBI were 0.717 (95% CI, 0.686-0.748; sensitivity 63.6%, specificity 72.7%), 0.846 (95% CI, 0.814-0.878; sensitivity 70.9%, specificity 88.5%), 0.625 (95% CI, 0.583-0.667; sensitivity 54.9%, specificity 67.9%), and 0.807 (95% CI, 0.761-0.853; sensitivity 60.6%, specificity 93.8%), respectively. TB scores were negatively correlated with bacterial load and C-reactive protein levels (both p < 0.001). Differences in TB scores were observed across treatment duration groups in this cross-sectional analysis.

Conclusion

Xpert MTB-HR did not fully meet WHO performance targets in the overall population, with performance influenced by pathogen load, particularly in low bacterial load or post-treatment patients. TB score showed patterns consistent with treatment response, warranting longitudinal validation.

Clinical trial

Not applicable.