WHO Grants Prequalification to Xpert MTB/RIF Ultra

The World Health Organization (WHO) has granted prequalification to the Xpert MTB/RIF Ultra, a molecular diagnostic test for tuberculosis (TB). This marks a significant milestone in global TB management as it is the first TB diagnostic test to meet WHO’s rigorous prequalification standards for both TB diagnosis and antibiotic susceptibility testing. The approval underscores WHO’s commitment to improving global TB control by ensuring access to high-quality diagnostic tools, particularly in low- and middle-income countries where TB remains a major health threat.

Tuberculosis continues to be one of the deadliest infectious diseases worldwide, with over a million deaths annually. The rapid rise of drug-resistant TB, particularly multidrug-resistant strains, has made timely and accurate diagnosis even more critical. Early detection is vital for effective treatment and to prevent the spread of resistant strains. Xpert MTB/RIF Ultra addresses these challenges by providing accurate, rapid results, including the identification of rifampicin resistance, a key marker for multidrug-resistant TB.

The Xpert® MTB/RIF Ultra, developed by Cepheid Inc., is designed for use with the GeneXpert® Instrument System. This nucleic acid amplification test (NAAT) detects the genetic material of Mycobacterium tuberculosis in sputum samples and provides results within hours. The test is especially critical for patients who have not started anti-tuberculosis treatment or have received less than three days of therapy in the past six months.

The pre-qualification of this test assures healthcare providers of its quality, safety, and performance and enables countries to scale up TB diagnosis efforts. According to Dr. Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products, this approval is a key part of the global health response to TB. Dr. Rogerio Gaspar, WHO Director for Regulation and Prequalification, emphasized that access to high-quality diagnostic tools is essential to controlling both TB and drug-resistant TB globally.

This achievement is part of WHO’s ongoing efforts to increase access to quality-assured TB tests and expand diagnostic options worldwide. The organization is currently reviewing additional TB diagnostic tests as part of its comprehensive approach to tackling the TB crisis.

More information: WHO.