By Bunmi Yekini
The World Health Organization (WHO) has granted prequalification status to the Xpert MTB/RIF Ultra, a molecular diagnostic test for tuberculosis (TB) and antibiotic susceptibility. This marks a significant milestone as the first TB diagnostic test to meet WHO’s stringent prequalification standards, setting a new benchmark for global TB care.
Tuberculosis, one of the leading infectious disease killers, causes over a million deaths annually, particularly in low- and middle-income countries. Early and accurate detection, especially of drug-resistant strains, remains a pressing challenge.
“This first prequalification of a diagnostic test for tuberculosis marks a critical milestone in WHO’s efforts to support countries in scaling up and accelerating access to high-quality TB assays,” said Dr. Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products. “It underscores the importance of such groundbreaking diagnostic tools in addressing one of the world’s deadliest infectious diseases.”
The Xpert MTB/RIF Ultra, developed by Cepheid Inc., operates on the GeneXpert Instrument System and detects the genetic material of Mycobacterium tuberculosis in sputum samples. Results are provided within hours, and the test can identify mutations associated with rifampicin resistance, a crucial marker of multidrug-resistant TB.
Dr. Rogerio Gaspar, WHO Director for Regulation and Prequalification, emphasized the importance of quality diagnostics in TB care: “High-quality diagnostic tests are the cornerstone of effective TB care and prevention. Prequalification paves the way for equitable access to cutting-edge technologies, empowering countries to address the dual burden of TB and drug-resistant TB.”
The prequalification process, conducted in collaboration with Singapore’s Health Sciences Authority, assures the test’s quality, safety, and performance. It complements WHO’s existing endorsement approach by prioritizing diagnostic accuracy, accessibility, and equity.
WHO is also assessing seven additional TB tests to expand diagnostic options globally, reinforcing its commitment to combating TB and its drug-resistant forms.