Rapid Communication: Molecular assays as initial tests for the diagnosis of tuberculosis and rifampicin resistance

Overview

Since the approval by WHO of Xpert® MTB/RIF (Cepheid, Sunnyvale, USA) in 2010, significant additional evidence has been generated on its use as initial test for the diagnosis of TB and rifampicin-resistant TB. In recent months new data on the use of Xpert® MTB/RIF Ultra (Cepheid, Sunnyvale, USA) and on the latest version Truenat® MTB and MTB Plus system (Molbio Diagnostics, Goa, India) have also become available.

WHO commissioned a systematic review of all the available data in 2019. The results were assessed during a meeting of an independent WHO-convened Guideline Development Group (GDG) on 3-6 December 2019. Detailed recommendations will be published as part of updated WHO Consolidated Guidelines on TB diagnosis in 2020.

This Rapid Communication aims to inform national TB programmes and other stakeholders about the key implications of the latest evidence on the use of specific molecular assays as initial diagnostic tests of pulmonary and extrapulmonary TB and RR-TB, in adults and children.