Xpert® MTB/RIF assay for extrapulmonary tuberculosis and rifampicin resistance

To determine the diagnostic accuracy of Xpert® MTB/RIF for the detection of extrapulmonary TB by site of disease in people suspected of having extrapulmonary TB. The role of Xpert® MTB/RIF would be a replacement for standard practice.

To determine the diagnostic accuracy of Xpert® MTB/RIF for detection of rifampicin resistance in people suspected of having extrapulmonary TB. The role of Xpert® MTB/RIF would be an initial test for replacement for culture-based DST.

We plan to investigate the impact of covariates on heterogeneity in estimates of test accuracy across the included studies.

Detection of extrapulmonary TB

The covariates of interest are: HIV prevalence; condition of the specimen (fresh versus frozen); sample input volume (for liquid specimens); homogenization step (for tissue specimens); smear status of specimen; past history of TB; and prevalence of extrapulmonary TB. In addition, we plan to explore whether the WHO standard operating procedures for a given type of specimen were followed and can explain the observed heterogeneity in accuracy estimates. For TB meningitis we plan to investigate whether the use of a concentration step prior to the use of Xpert® MTB/RIF has an impact on accuracy estimates. In addition, for detection of lymph node TB, pleural TB, and TB meningitis, we plan to adjust accuracy estimates by applying a latent class meta-analysis model to account for the imperfect nature of culture as the reference standard.

Detection of rifampicin resistance detection

The covariate of interest is the prevalence of rifampicin resistance.

This is a protocol.

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