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Updated: Nov 22, 2025

Diagnosing Pulmonary Tuberculosis with the Xpert MTB/RIF Test
Published on: April 9, 2012
A Prospective Evaluation of Xpert MTB/RIF Ultra for Childhood Pulmonary Tuberculosis in Uganda
Devan Jaganath1,2,3, Peter Wambi4, Tania F Reza2,3
1Division of Pediatric Infectious Diseases, University of California-San Francisco, San Francisco, California, USA.
Insights
The Xpert MTB/RIF Ultra test shows promise for diagnosing childhood tuberculosis (TB). However, its sensitivity in detecting culture-negative TB in children requires further improvement for better pediatric TB diagnosis.
Area of Science:
- Pediatric infectious diseases
- Diagnostic microbiology
- Public health
Background:
- Xpert MTB/RIF Ultra (Xpert Ultra) enhances tuberculosis (TB) detection sensitivity in adults.
- Limited prospective studies evaluate Xpert Ultra's diagnostic accuracy in pediatric populations.
Purpose of the Study:
- To prospectively evaluate the diagnostic accuracy of Xpert Ultra for pulmonary TB in children.
- To compare Xpert Ultra performance against various reference standards.
Main Methods:
- Children assessed for pulmonary TB in Kampala, Uganda, were enrolled over 12 months.
- Diagnostic accuracy was determined using clinical, microbiological, and extended microbiological reference standards (MRSs).
- Sensitivity and specificity were calculated for Xpert Ultra against Confirmed vs. Unlikely TB classifications.
Main Results:
- Xpert Ultra sensitivity was 69.6% for Confirmed TB, decreasing to 23.4% with a clinical reference standard.
- Specificity was 100% for Unlikely TB, decreasing to 94.7% with a MRS.
- Sensitivity was 52.9% and specificity 95.5% with the extended MRS; 23.1% of positive results were 'Trace-positive'.
Conclusions:
- Xpert Ultra is a valuable tool for diagnosing pulmonary TB in children.
- Further development of more sensitive tests is needed for culture-negative pediatric TB.
Background:
Xpert MTB/RIF Ultra (Xpert Ultra) has improved the sensitivity to detect pulmonary tuberculosis (TB) in adults. However, there have been limited prospective evaluations of its diagnostic accuracy in children.
Methods:
We enrolled children undergoing assessment for pulmonary TB in Kampala, Uganda, over a 12-month period. Children received a complete TB evaluation and were classified as Confirmed, Unconfirmed, or Unlikely TB. We calculated the sensitivity and specificity of Xpert Ultra among children with Confirmed vs Unlikely TB. We also determined the diagnostic accuracy with clinical, microbiological, and extended microbiological reference standards (MRSs).
Results:
Of the 213 children included, 23 (10.8%) had Confirmed TB, 88 (41.3%) had Unconfirmed TB, and 102 (47.9%) had Unlikely TB. The median age was 3.9 years, 13% were HIV-positive, and 61.5% were underweight. Xpert Ultra sensitivity was 69.6% (95% confidence interval [CI]: 47.1-86.8) among children with Confirmed TB and decreased to 23.4% (95% CI: 15.9-32.4) with the clinical reference standard. Specificity was 100% (95% CI: 96.4-100) among children with Unlikely TB and decreased to 94.7% (95% CI: 90.5-97.4) with a MRS. Sensitivity was 52.9% (95% CI: 35.1-70.2) and specificity 95.5% (95% CI: 91.4-98.1) with the extended MRS. Of the 26 positive Xpert Ultra results, 6 (23.1%) were "Trace-positive," with most (5/6) occurring in children with Unconfirmed TB.
Conclusions:
Xpert Ultra is a useful tool for diagnosing pulmonary TB in children, but there remains a need for more sensitive tests to detect culture-negative TB.
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