Piloting Upfront Xpert MTB/RIF Testing on Various Specimens under Programmatic Conditions for Diagnosis of TB & DR-TB

Neeraj Raizada1, Kuldeep Singh Sachdeva2, Soumya Swaminathan3

  • 1Foundation for Innovative New Diagnostics, New Delhi, India.

Plos One
|October 16, 2015
PubMed

Insights

The Xpert MTB/RIF test significantly improved diagnosing childhood tuberculosis (TB) in India. This rapid test confirmed TB cases more effectively than traditional methods and detected drug-resistant TB in children.

Area of Science:

  • Pediatric infectious diseases
  • Mycobacteriology
  • Diagnostic microbiology

Background:

  • India faces a substantial burden of tuberculosis (TB), contributing one-fifth of global cases.
  • Childhood TB is a major cause of mortality in India, with diagnostic challenges due to difficulties in obtaining quality specimens.
  • Bacteriological confirmation in children is often limited, relying heavily on clinical judgment.

Purpose of the Study:

  • To pilot the upfront use of Xpert MTB/RIF testing for diagnosing TB in pediatric populations.
  • To evaluate the effectiveness of Xpert MTB/RIF in both respiratory and extra-pulmonary specimens in children.
  • To assess the test's performance in detecting rifampicin resistance in pediatric TB cases.

Main Methods:

  • Xpert MTB/RIF testing was implemented for all presumptive pediatric TB cases (0-14 years) across public and private health facilities in four Indian cities.
  • Testing included both pulmonary and extra-pulmonary specimens, with a focus on non-sputum samples.
  • Data were collected on test validity, TB confirmation rates, and detection of rifampicin resistance.

Main Results:

  • Over 8,000 presumptive pediatric TB cases were tested, with nearly 9,150 specimens analyzed, including a significant proportion of non-sputum samples.
  • The Xpert MTB/RIF assay demonstrated high validity (99.2%) and confirmed 6.3% of presumptive TB cases.
  • TB detection rates were doubled compared to smear microscopy, and 60 cases of rifampicin-resistant TB were identified.

Conclusions:

  • The Xpert MTB/RIF assay substantially improved the diagnosis of bacteriologically confirmed TB in children.
  • The test offers advantages including rapid turnaround time, a high proportion of interpretable results, and feasibility for rapid implementation.
  • Simultaneous detection of rifampicin resistance provides crucial information for treatment decisions in pediatric TB.
Abstract

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