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.

The Journal of Infection
|October 15, 2014
PubMed

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.
Abstract

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