On Dec. 5, 2024, the World Health Organization (WHO) has granted prequalification to the molecular diagnostic test for tuberculosis (TB) called Xpert® MTB/RIF Ultra. It is the first test for TB diagnosis and antibiotic susceptibility testing that meets WHO’s prequalification standards.

Tuberculosis is one of the world’s leading infectious disease killers, causing over a million deaths annually and imposing immense socioeconomic burdens, especially in low- and middle-income countries. Accurate and early detection of TB, especially drug-resistant strains, remains a critical and challenging global health priority.

Designed for use on the GeneXpert® Instrument System, this nucleic acid amplification test (NAAT) Xpert® MTB/RIF Ultra detects the genetic material of Mycobacterium tuberculosis, the bacterium that causes TB, in sputum samples, and provides accurate results within hours. Simultaneously, the test identifies mutations associated with rifampicin resistance, a key indicator of multidrug-resistant TB.
It is intended for patients who screen positive for pulmonary TB and who have either not started anti-tuberculosis treatment or received less than three days of therapy in the past six months.