Tuberculosis and Respiratory Diseases

The Korean Academy of Tuberculosis and Respiratory Diseases (대한결핵및호흡기학회)
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Comparative Performance of Line Probe Assay (Version 2) and Xpert MTB/RIF Assay for Early Diagnosis of Rifampicin-Resistant Pulmonary Tuberculosis

  • Yadav, Raj Narayan (Department of Medicine, All India Institute of Medical Sciences) ;
  • Singh, Binit Kumar (Department of Medicine, All India Institute of Medical Sciences) ;
  • Sharma, Rohini (Department of Medicine, All India Institute of Medical Sciences) ;
  • Chaubey, Jigyasa (Department of Medicine, All India Institute of Medical Sciences) ;
  • Sinha, Sanjeev (Department of Medicine, All India Institute of Medical Sciences) ;
  • Jorwal, Pankaj (Department of Medicine, All India Institute of Medical Sciences)
  • Received : 2020.12.31
  • Accepted : 2021.03.03
  • Published : 2021.07.31
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Abstract

Background: The emergence of drug-resistant tuberculosis (TB), is a major menace to cast off TB worldwide. Line probe assay (LPA; GenoType MTBDRplus ver. 2) and Xpert MTB/RIF assays are two rapid molecular TB detection/diagnostic tests. To compare the performance of LPA and Xpert MTB/RIF assay for early diagnosis of rifampicin-resistant (RR) TB in acid-fast bacillus (AFB) smear-positive and negative sputum samples. Methods: A total 576 presumptive AFB patients were selected and subjected to AFB microscopy, Xpert MTB/RIF assay and recent version of LPA (GenoType MTBDRplus assay version 2) tests directly on sputum samples. Results were compared with phenotypic culture and drug susceptibility testing (DST). DNA sequencing was performed with rpoB gene for samples with discordant rifampicin susceptibility results. Results: Among culture-positive samples, Xpert MTB/RIF assay detected Mycobacterium tuberculosis (Mtb) in 97.3% (364/374) of AFB smear-positive samples and 76.5% (13/17) among smear-negative samples, and the corresponding values for LPA test (valid results with Mtb control band) were 97.9% (366/374) and 58.8% (10/17), respectively. For detection of RR among Mtb positive molecular results, the sensitivity of Xpert MTB/RIF assay and LPA (after resolving discordant phenotypic DST results with DNA sequencing) were found to be 96% and 99%, respectively. Whereas, specificity of both test for detecting RR were found to be 99%. Conclusion: We conclude that although Xpert MTB/RIF assay is comparatively superior to LPA in detecting Mtb among AFB smear-negative pulmonary TB. However, both tests are equally efficient in early diagnosis of AFB smear-positive presumptive RR-TB patients.

Keywords

Acknowledgement

We are thankful to the staff of Department of Medicine for their help in carrying out this study. Authors acknowledge the support of Foundation for Innovative New Diagnostics (FIND) India for providing logistic support.

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