SWITZERLAND – The World Health Organization (WHO) has granted prequalification to the Xpert MTB/RIF Ultra, a molecular diagnostic test designed to detect tuberculosis (TB) and drug resistance with speed and precision.
This milestone marks the first TB diagnostic test to meet WHO’s stringent prequalification standards, ensuring high levels of quality, safety, and performance.
By achieving this status, the test is set to enhance global efforts in combating one of the deadliest infectious diseases.
Tuberculosis remains a leading cause of death worldwide, with over a million lives lost annually, predominantly in low- and middle-income countries.
The disease not only imposes a significant health burden but also disrupts economic and social systems in affected regions.
The challenge of detecting TB, particularly drug-resistant strains, has long hindered efforts to control its spread.
Early and accurate diagnosis is critical for initiating timely treatment and improving patient outcomes.
The Xpert MTB/RIF Ultra is a nucleic acid amplification test (NAAT) designed for use on the GeneXpert Instrument System.
It detects the genetic material of Mycobacterium tuberculosis in sputum samples and simultaneously identifies mutations associated with rifampicin resistance, a key marker for multidrug-resistant TB.
Results are delivered within hours, significantly reducing the time required for diagnosis compared to traditional methods.
This rapid turnaround enables quicker initiation of appropriate treatment, which is vital for containing the disease and preventing further transmission.
The prequalification process for the Xpert MTB/RIF Ultra was conducted based on data submitted by its manufacturer, Cepheid Inc., and a thorough review by Singapore’s Health Sciences Authority.
WHO’s prequalification ensures that diagnostic tools meet stringent criteria for accuracy, reliability, and safety, providing healthcare providers and patients with confidence in their use.
Dr. Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products, emphasized the significance of this achievement, stating, “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.”
Dr. Rogerio Gaspar, WHO Director for Regulation and Prequalification, further highlighted that “high-quality diagnostic tests are the cornerstone of effective TB care and prevention.”
The Xpert MTB/RIF Ultra is particularly intended for patients who test positive for pulmonary TB and have not yet started or recently initiated treatment.
By enabling rapid, high-quality diagnosis, the test aligns with WHO’s goals of improving global health equity, especially in resource-limited settings.
This development also complements ongoing efforts to expand access to TB diagnostics.
WHO is currently assessing seven additional TB tests through its Global TB Program and the Department of Regulation and Prequalification, aiming to broaden the range of quality-assured diagnostic tools available.
