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Background <p>Despite tuberculous lymphadenitis (TBL) being the most prevalent type of extrapulmonary tuberculosis, there are limitations in laboratory diagnosis of TBL due to high cost, inadequate diagnostic efficacy and feasibility. Xpert MTB/RIF (Xpert) assay is a design-locked, molecular diagnostic technique that detects <i>Mycobacterium tuberculosis</i> (MTB) genome and rifampicin resistance by targeting <i>rpoB</i> gene and mutations within the gene. Currently, there is limited evidence validating Xpert assay usage for diagnosing TBL in Bangladesh. Therefore, in this study, we evaluated diagnostic efficacy of Xpert, considering composite reference standard (CRS), i.e. combination of acid-fast bacilli (AFB) microscopy, culture, Xpert assay and cytology, as gold standard, and compared it to cytology.</p> Methods <p>AFB microscopy, culture, cytology, and Xpert assay were conducted on fine needle aspirates collected from 523 presumptive TBL patients. Genomic DNA was extracted from bacterial colonies of culture-positive specimens. In order to confirm presence of MTB, PCR and gel electrophoresis were performed on extracted DNA to detect RD9 region of MTB DNA. Sensitivity, specificity, positive and negative predictive values, and Cohen’s kappa coefficient were determined, and McNemar’s test was performed for Xpert and cytology with respect to CRS. Additionally, latent class analysis was performed to estimate sensitivity and specificity of all four diagnostic modalities.</p> Results <p>Xpert showed sensitivity and specificity of 72.9% (261/358) and 100% (165/165) respectively against CRS, with 69.8% sensitivity and 97.1% specificity using Bayesian latent class modeling. In contrast, cytology demonstrated sensitivity and specificity of 84.1% (301/358) and 100% (165/165) against CRS, and 81.9% and 99.9% upon latent class analysis, respectively. Furthermore, Xpert showed moderate agreement with cytology (κ = 0.45, <i>p</i> &lt; 0.0001), fair agreement with culture (κ = 0.30, <i>p</i> &lt; 0.0001), and poor agreement with AFB microscopy (κ = 0.09, <i>p</i> &lt; 0.0001).</p> Conclusion <p>Our study findings validate routinely using Xpert assay in TBL diagnosis and enable detecting patients with low bacterial load. However, further assessment via cytology is recommended for confirmation in Xpert-negative patients having patent symptoms.</p> Clinical trial <p>Not applicable.</p>

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Improved detection of Mycobacterium tuberculosis in lymph node aspirates through GeneXpert MTB/RIF assay in Bangladesh

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年1月22日

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  • Mohammad Sohel Shomik,
  • Nishad Tasnim Mithila,
  • Prakash Ghosh,
  • M. Mamun Huda,
  • Md. Rasel Uddin,
  • Md. Golam Hasnain,
  • Tanvir Ahmed Siddiqui,
  • Syed Mohammad Mazidur Rahman,
  • Kanu Lal Saha,
  • Nasima Akhtar,
  • Jason R. Andrews,
  • Sayera Banu,
  • Ahmed Abd El Wahed,
  • Dinesh Mondal

摘要

Background

Despite tuberculous lymphadenitis (TBL) being the most prevalent type of extrapulmonary tuberculosis, there are limitations in laboratory diagnosis of TBL due to high cost, inadequate diagnostic efficacy and feasibility. Xpert MTB/RIF (Xpert) assay is a design-locked, molecular diagnostic technique that detects Mycobacterium tuberculosis (MTB) genome and rifampicin resistance by targeting rpoB gene and mutations within the gene. Currently, there is limited evidence validating Xpert assay usage for diagnosing TBL in Bangladesh. Therefore, in this study, we evaluated diagnostic efficacy of Xpert, considering composite reference standard (CRS), i.e. combination of acid-fast bacilli (AFB) microscopy, culture, Xpert assay and cytology, as gold standard, and compared it to cytology.

Methods

AFB microscopy, culture, cytology, and Xpert assay were conducted on fine needle aspirates collected from 523 presumptive TBL patients. Genomic DNA was extracted from bacterial colonies of culture-positive specimens. In order to confirm presence of MTB, PCR and gel electrophoresis were performed on extracted DNA to detect RD9 region of MTB DNA. Sensitivity, specificity, positive and negative predictive values, and Cohen’s kappa coefficient were determined, and McNemar’s test was performed for Xpert and cytology with respect to CRS. Additionally, latent class analysis was performed to estimate sensitivity and specificity of all four diagnostic modalities.

Results

Xpert showed sensitivity and specificity of 72.9% (261/358) and 100% (165/165) respectively against CRS, with 69.8% sensitivity and 97.1% specificity using Bayesian latent class modeling. In contrast, cytology demonstrated sensitivity and specificity of 84.1% (301/358) and 100% (165/165) against CRS, and 81.9% and 99.9% upon latent class analysis, respectively. Furthermore, Xpert showed moderate agreement with cytology (κ = 0.45, p < 0.0001), fair agreement with culture (κ = 0.30, p < 0.0001), and poor agreement with AFB microscopy (κ = 0.09, p < 0.0001).

Conclusion

Our study findings validate routinely using Xpert assay in TBL diagnosis and enable detecting patients with low bacterial load. However, further assessment via cytology is recommended for confirmation in Xpert-negative patients having patent symptoms.

Clinical trial

Not applicable.