Xpert MTB/RIF and Xpert MTB/RIF Ultra assays for active tuberculosis and rifampicin resistance in children

Primary objectives

To determine the diagnostic accuracy of Xpert MTB/RIF and Xpert Ultra for a) PTB in children presumed to have tuberculosis; b) lymph node tuberculosis in children presumed to have tuberculosis; c) tuberculous meningitis in children presumed to have tuberculosis; and d) rifampicin resistance in children presumed to have tuberculosis.

For tuberculosis detection, the role of the index tests would be a replacement for standard practice.

For rifampicin resistance detection, the role of the index tests would be an initial replacement test for culture-based drug susceptibility testing.

  • To compare the accuracy of Xpert MTB/RIF and Xpert Ultra for each of the four target conditions;
  • To investigate potential sources of heterogeneity in accuracy estimates. For tuberculosis detection, covariates include age, disease severity, smear-test status, HIV status, clinical setting, specimen type, high tuberculosis burden, and high tuberculosis/HIV burden. For rifampicin resistance detection, the covariate of interest is multidrug-resistant tuberculosis burden.

This is a protocol.

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