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.
Abstract

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