Xpert MTB/RIF assay for diagnosis of pulmonary tuberculosis in children

A prospective, multi-centre evaluation

Klaus Reither, Christina Manyama, Petra Clowes, Andrea Rachow, Daniel Mapamba, Andreas Steiner, Amanda Ross, Elirehema Mfinanga, Mohamed Sasamalo, Martin Nsubuga, Francesco Aloi, Daniela Cirillo, Levan Jugheli, Fred Lwilla

Research output: Contribution to journalArticle

16 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)392-399
Number of pages8
JournalJournal of Infection
Volume70
Issue number4
DOIs
Publication statusPublished - Apr 1 2015

Fingerprint

Pulmonary Tuberculosis
Tuberculosis
Uganda
Tanzania
Microscopy
Sensitivity and Specificity

Keywords

  • Childhood tuberculosis
  • Diagnostics
  • Evaluation
  • Pulmonary tuberculosis
  • Xpert MTB/RIF

ASJC Scopus subject areas

  • Microbiology (medical)
  • Infectious Diseases
  • Medicine(all)

Cite this

Reither, K., Manyama, C., Clowes, P., Rachow, A., Mapamba, D., Steiner, A., ... Lwilla, F. (2015). Xpert MTB/RIF assay for diagnosis of pulmonary tuberculosis in children: A prospective, multi-centre evaluation. Journal of Infection, 70(4), 392-399. https://doi.org/10.1016/j.jinf.2014.10.003

Xpert MTB/RIF assay for diagnosis of pulmonary tuberculosis in children : A prospective, multi-centre evaluation. / Reither, Klaus; Manyama, Christina; Clowes, Petra; Rachow, Andrea; Mapamba, Daniel; Steiner, Andreas; Ross, Amanda; Mfinanga, Elirehema; Sasamalo, Mohamed; Nsubuga, Martin; Aloi, Francesco; Cirillo, Daniela; Jugheli, Levan; Lwilla, Fred.

In: Journal of Infection, Vol. 70, No. 4, 01.04.2015, p. 392-399.

Research output: Contribution to journalArticle

Reither, K, Manyama, C, Clowes, P, Rachow, A, Mapamba, D, Steiner, A, Ross, A, Mfinanga, E, Sasamalo, M, Nsubuga, M, Aloi, F, Cirillo, D, Jugheli, L & Lwilla, F 2015, 'Xpert MTB/RIF assay for diagnosis of pulmonary tuberculosis in children: A prospective, multi-centre evaluation', Journal of Infection, vol. 70, no. 4, pp. 392-399. https://doi.org/10.1016/j.jinf.2014.10.003
Reither, Klaus ; Manyama, Christina ; Clowes, Petra ; Rachow, Andrea ; Mapamba, Daniel ; Steiner, Andreas ; Ross, Amanda ; Mfinanga, Elirehema ; Sasamalo, Mohamed ; Nsubuga, Martin ; Aloi, Francesco ; Cirillo, Daniela ; Jugheli, Levan ; Lwilla, Fred. / Xpert MTB/RIF assay for diagnosis of pulmonary tuberculosis in children : A prospective, multi-centre evaluation. In: Journal of Infection. 2015 ; Vol. 70, No. 4. pp. 392-399.
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abstract = "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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AU - Clowes, Petra

AU - Rachow, Andrea

AU - Mapamba, Daniel

AU - Steiner, Andreas

AU - Ross, Amanda

AU - Mfinanga, Elirehema

AU - Sasamalo, Mohamed

AU - Nsubuga, Martin

AU - Aloi, Francesco

AU - Cirillo, Daniela

AU - Jugheli, Levan

AU - Lwilla, Fred

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N2 - 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.

AB - 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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KW - Diagnostics

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