In December 2010, WHO first recommended the use of the Xpert MTB/RIF assay. The WHO's policy statement was supported by a rapid implementation document, which provided the technical "how-to" and operational considerations for rolling out the use of the assay. An unprecedented uptake of this new technology followed the release of WHO's policy: by the end of March 2014, more than 2,300 GeneXpert instruments and more than 6 million Xpert MTB/RIF cartridges had been procured in the public sector in 104 countries eligible for concessional prices.

An Expert Group was convened by WHO in May 2013 to review the current body of evidence on use of Xpert MTB/RIF. The resulting recommendations from the Expert Group are included in the WHO Policy update, which widens the recommended use of Xpert MTB/RIF, including for the diagnosis of paediatric TB and on selected specimens for the diagnosis of extrapulmonary TB, and includes an additional recommendation on the use of Xpert MTB/RIF as the initial diagnostic test in all individuals presumed to have pulmonary TB.

The accompanying Xpert MTB/RIF implementation manual has been developed to replace the first edition and takes into consideration the current body of evidence and operational experiences available, in the context of the Policy update.