Use of Xpert MTB/RIF and Xpert MTB/RIF Ultra on GeneXpert 10-colour instruments – WHO Policy Statement

Following review of the evidence and advice from the Technical Advisory Group (TAG) on Tuberculosis (TB) Diagnostics and Laboratory Strengthening, the World Health Organization (WHO) concludes that the Xpert MTB/RIF and Ultra cartridge performance on the GeneXpert 10-colour instrument was found to be comparable to that of the GeneXpert 6-colour instrument for detection of TB and rifampicin resistance. The current WHO recommendations for Xpert MTB/RIF and Ultra cartridge use on GeneXpert 6-colour instruments are also valid for their use on GeneXpert 10-colour instruments. Full details are provided in the WHO policy statement.

Rapid and more accurate diagnostic tools are critical to achieving the global targets towards ending the TB epidemic. WHO recommends the Xpert MTB/RIF and Xpert MTB/RIF Ultra (Ultra) tests for the detection of TB and rifampicin-resistant TB, performed on GeneXpert instruments with 6-colour optics. A new GeneXpert instrument with 10-color optics was introduced for use with the recently WHO recommended first-in-class test, the Xpert MTB/XDR, diagnosing resistance to fluoroquinolone and other second-line drugs. Having a single instrument with 10-color optics that could be used to detect TB, resistance to first- and second-line drugs would simplify workflow and facilitate implementation. It should however be noted that Xpert MTB/XDR cannot be used on the existing 6-color instruments. The new WHO guidance should provide clarity, facilitate procurement and uptake of these technologies and improve patient care.