The World Health Organization (WHO) has announced the prequalification of the Xpert® MTB/RIF Ultra molecular diagnostic test for tuberculosis (TB), marking a significant milestone in the fight against one of the world’s deadliest infectious diseases. This is the first TB diagnostic and antibiotic susceptibility test to meet WHO’s stringent prequalification standards, ensuring high quality, safety, and performance.
A Game-Changer in TB Detection
Tuberculosis remains a leading infectious killer globally, claiming over a million lives annually, with devastating socioeconomic impacts, particularly in low- and middle-income countries. The Xpert® MTB/RIF Ultra test detects Mycobacterium tuberculosis, the bacterium responsible for TB, in sputum samples within hours and identifies mutations indicating resistance to rifampicin, a critical marker of multidrug-resistant TB.
The test is designed for use on the GeneXpert® Instrument System and is recommended for patients who test positive for pulmonary TB but have not undergone more than three days of treatment in the past six months.
WHO’s Endorsement
“This first prequalification of a diagnostic test for tuberculosis marks a critical milestone,” stated Dr. Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products. “It underscores the importance of groundbreaking diagnostic tools in addressing one of the world’s deadliest infectious diseases.”
Prequalification provides assurance that the diagnostic meets WHO’s rigorous standards, enabling countries to scale up access to reliable TB diagnostics. It complements WHO’s evidence-based endorsement approach, which emphasizes diagnostic accuracy, patient outcomes, accessibility, and equity.
Accelerating Global TB Efforts
The prequalification assessment, based on submissions by Cepheid Inc. and regulatory review by Singapore’s Health Sciences Authority (HSA), is part of WHO’s broader effort to enhance access to high-quality TB diagnostic tools. This initiative is led by WHO’s Global TB Programme and the Department of Regulation and Prequalification.
Dr. Rogerio Gaspar, WHO Director for Regulation and Prequalification, highlighted the critical role of diagnostics in TB care: “Prequalification paves the way for equitable access to cutting-edge technologies, empowering countries to address the dual burden of TB and drug-resistant TB.”
Future Prospects
WHO is currently assessing seven additional TB diagnostic tests to expand diagnostic options and enhance access to quality-assured tools globally.
This milestone strengthens global efforts to combat TB and drug-resistant strains, fostering early detection and treatment while addressing critical gaps in healthcare delivery, particularly in resource-constrained settings.
