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Updated: Mar 31, 2026

Diagnosing Pulmonary Tuberculosis with the Xpert MTB/RIF Test
Published on: April 9, 2012
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.
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.
Background:
India accounts for one-fifth of the global TB incidence. While the exact burden of childhood TB is not known, TB remains one of the leading causes of childhood mortality in India. Bacteriological confirmation of TB in children is challenging due to difficulty in obtaining quality specimens, in the absence of which diagnosis is largely based on clinical judgement. While testing multiple specimens can potentially contribute to higher proportion of laboratory confirmed paediatric TB cases, lack of high sensitivity tests adds to the diagnostic challenge. We describe here our experiences in piloting upfront Xpert MTB/RIF testing, for diagnosis of TB in paediatric population in respiratory and extra pulmonary specimens, as recently recommended by WHO.
Method:
Xpert MTB/RIF testing was offered to all paediatric (0-14 years) presumptive TB cases (both pulmonary and extra-pulmonary) seeking care at public and private health facilities in the project areas covering 4 cities of India.
Results:
Under this pilot project, 8,370 paediatric presumptive TB & presumptive DR-TB cases were tested between April and-November 2014. Overall, 9,149 specimens were tested, of which 4,445 (48.6%) were non-sputum specimens. Xpert MTB/RIF gave 9,083 (99.2%, CI 99.0-99.4) valid results. Of the 8,143 presumptive TB cases enrolled, 517 (6.3%, CI 5.8-6.9) were bacteriologically confirmed. TB detection rates were two fold higher with Xpert MTB/RIF as compared to smear microscopy. Further, a total of 60 rifampicin resistant TB cases were detected, of which 38 were detected among 512 presumptive TB cases while 22 were detected amongst 227 presumptive DR-TB cases tested under the project.
Conclusion:
Xpert MTB/RIF with advantages of quick turnaround testing-time, high proportion of interpretable results and feasibility of rapid rollout, substantially improved the diagnosis of bacteriologically confirmed TB in children, while simultaneously detecting rifampicin resistance.
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