The World Health Organization (WHO) has prequalified the Xpert® MTB/RIF Ultra, the first molecular diagnostic test for tuberculosis (TB) and antibiotic susceptibility testing to meet WHO’s stringent quality, safety, and performance standards. This innovative test detects mycobacterium tuberculosis and rifampicin resistance within hours, providing a crucial tool to combat drug-resistant TB.
Designed for use on the GeneXpert® instrument System, this nucleic acid amplification test (NAAT) is a game-changer for patients who screen positive for pulmonary TB and who have either not started anti-tuberculosis treatment or received less than 3 days of therapy in the past six months.
“Prequalification paves the way for equitable access to cutting-edge technologies, empowering countries to address the dual burden of TB and drug-resistant TB,” said Dr. Rogerio Gaspar, WHO Director for Regulation and Prequalification.
This initiative complements WHO’s endorsement strategy, which focuses on emerging evidence, diagnostic accuracy and patient outcomes. By prequalifying this test, WHO aims to ensure the availability of high-quality diagnostic tools to improve early detection and treatment of TB, which causes over a million deaths annually, particularly in low- and middle-income countries.
The test, manufactured by Cepheid Inc., underwent rigorous quality assurance in collaboration with Singapore’s Health Sciences Authority (HSA). WHO is also assessing seven additional TB tests to expand diagnostic options for countries and support the scale-up of high-quality TB care globally.
