Abstract

Objectives This is a protocol for a Cochrane Review (diagnostic). The objectives are as follows: To determine the diagnostic accuracy of Truenat assays (MTB, MTB Plus, and MTB RIF Dx) for detecting pulmonary tuberculosis and rifampicin resistance in adults with presumptive pulmonary tuberculosis. Secondary objectives To compare the diagnostic accuracy of Truenat assays (MTB, MTB Plus, and MTB RIF Dx) with that of Xpert MTB/RIF Ultra for the detection of pulmonary tuberculosis and rifampicin resistance in adults with presumptive pulmonary tuberculosis. To summarize the frequency of non‐determinate Truenat results. To determine the diagnostic accuracy of Truenat after repeat testing in people with non‐determinate test results. To investigate potential sources of heterogeneity in the diagnostic accuracy of Truenat for the detection of pulmonary tuberculosis in relation to covariates such as the setting where the index tests were performed, HIV status, previous history of tuberculosis, and sputum smear test status. To investigate heterogeneity in the diagnostic accuracy of Truenat for detecting rifampicin resistance in relation to sputum smear status.

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