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Updated: Apr 22, 2026

Diagnosing Pulmonary Tuberculosis with the Xpert MTB/RIF Test
Published on: April 9, 2012
Xpert MTB/RIF assay for diagnosis of pulmonary tuberculosis in children: a prospective, multi-centre evaluation
Klaus Reither1, Christina Manyama2, Petra Clowes3
1Swiss Tropical and Public Health Institute, Basel, Switzerland; University of Basel, Basel, Switzerland; Ifakara Health Institute, Bagamoyo, Tanzania.
Insights
The Xpert MTB/RIF assay shows moderate sensitivity and excellent specificity for diagnosing childhood tuberculosis (TB), outperforming smear microscopy. However, its yield in probable TB cases needs improvement.
Area of Science:
- Pediatric infectious diseases
- Diagnostic microbiology
- Global health
Background:
- The World Health Organization recommends the Xpert MTB/RIF assay for tuberculosis (TB) diagnosis.
- Limited data exist on the Xpert MTB/RIF assay's performance in pediatric populations.
- This study addresses the need for evaluating TB diagnostic tools in children.
Purpose of the Study:
- To evaluate the diagnostic performance of the Xpert MTB/RIF assay in children with suspected pulmonary tuberculosis.
- To compare the Xpert MTB/RIF assay to culture-confirmed TB cases in a pediatric cohort.
- To assess the assay's utility in TB-endemic settings.
Main Methods:
- A prospective, multi-center study enrolled 451 children (older than 8 weeks, younger than 16 years) in Tanzania and Uganda.
- Children were categorized into five case definitions: culture-confirmed TB, highly probable TB, probable TB, not TB, or indeterminate.
- Diagnostic accuracy was determined using culture-confirmed TB as the reference standard.
Main Results:
- The Xpert MTB/RIF assay demonstrated a sensitivity of 68% (95% CI, 50%-82%) and a specificity of 100% (95% CI, 97%-100%).
- The assay identified 1.7 times more culture-confirmed TB cases than smear microscopy with comparable detection times.
- Positive results were observed in 2% of highly probable and 3% of probable TB cases.
Conclusions:
- The Xpert MTB/RIF assay offers timely results with moderate sensitivity and high specificity for pediatric TB diagnosis.
- While effective, the assay's low yield in children with probable or highly probable TB requires further investigation.
- The findings highlight the need for improved diagnostic strategies for TB in children.
Background:
Following endorsement by the World Health Organisation, the Xpert MTB/RIF assay has been widely incorporated into algorithms for the diagnosis of adult tuberculosis (TB). However, data on its performance in children remain scarce. This prospective, multi-centre study evaluated the performance of Xpert MTB/RIF to diagnose pulmonary tuberculosis in children.
Methods:
Children older than eight weeks and younger than 16 years with suspected pulmonary tuberculosis were enrolled at three TB endemic settings in Tanzania and Uganda, and assigned to five well-defined case definition categories: culture-confirmed TB, highly probable TB, probable TB, not TB, or indeterminate. The diagnostic accuracy of Xpert MTB/RIF was assessed using culture-confirmed TB cases as reference standard.
Results:
In total, 451 children were enrolled. 37 (8%) had culture-confirmed TB, 48 (11%) highly probably TB and 62 probable TB (13%). The Xpert MTB/RIF assay had a sensitivity of 68% (95% CI, 50%-82%) and specificity of 100% (95% CI, 97%-100%); detecting 1.7 times more culture-confirmed cases than smear microscopy with a similar time to detection. Xpert MTB/RIF was positive in 2% (1/48) of highly probable and in 3% (2/62) of probable TB cases.
Conclusions:
Xpert MTB/RIF provided timely results with moderate sensitivity and excellent specificity compared to culture. Low yields in children with highly probable and probable TB remain problematic.
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