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Diagnosing Pulmonary Tuberculosis with the Xpert MTB/RIF Test
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Redefining MTBDRplus test results: what do indeterminate results actually mean?

C Nikam1, R Patel1, M Sadani1

  • 1Department of Microbiology, P D Hinduja Hospital and Medical Research Centre, Mumbai, India.

The International Journal of Tuberculosis and Lung Disease : the Official Journal of the International Union Against Tuberculosis and Lung Disease
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Indeterminate results from line-probe assays (LPAs) for tuberculosis diagnosis can be resolved using pyrosequencing (PSQ). This method confirms drug susceptibility for isoniazid and rifampicin in a significant portion of these ambiguous cases.

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Area of Science:

  • Microbiology
  • Molecular Diagnostics
  • Infectious Diseases

Background:

  • Line-probe assays (LPAs) show promise for tuberculosis diagnosis but require further investigation regarding indeterminate results.
  • Limited research exists on the performance of LPAs across diverse clinical samples.

Purpose of the Study:

  • To assess the performance of the GenoType MTBDRplus LPA compared to BACTEC MGIT 960 culture and drug susceptibility testing (DST).
  • To evaluate the utility of pyrosequencing (PSQ) in resolving indeterminate LPA results.

Main Methods:

  • The GenoType MTBDRplus LPA was used on 308 pulmonary and 32 extra-pulmonary TB samples.
  • Indeterminate results were further analyzed using pyrosequencing (PSQ).
  • Results were compared against conventional culture and DST.

Main Results:

  • The MTBDRplus assay demonstrated 95.2% sensitivity and 95.1% specificity for multidrug-resistant TB.
  • 13.7% of samples yielded indeterminate results for isoniazid and/or rifampicin.
  • Pyrosequencing confirmed susceptibility in 7.5% for isoniazid and 27.5% for rifampicin among indeterminate samples.

Conclusions:

  • Pyrosequencing is a valuable and rapid tool for resolving uninterpretable LPA results.
  • PSQ aids in accurate drug susceptibility determination for tuberculosis.
  • Addressing indeterminate LPA results improves diagnostic accuracy.