The World Health Organisation (WHO) has granted prequalification to Xpert® MTB/RIF Ultra, a pioneering molecular diagnostic test for tuberculosis (TB).
This makes it the first TB diagnostic tool to meet WHO’s rigorous standards for quality, safety, and performance.
Tuberculosis remains a major global health threat, claiming over a million lives annually, with drug-resistant strains posing an even greater challenge.
Early detection of TB, particularly these resistant strains, is crucial for improving treatment outcomes. Dr. Yukiko Nakatani, WHO’s Assistant Director-General for Access to Medicines and Health Products,stressed in a statement made public on the organisation website on Thursday sating, “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.”
The Xpert® MTB/RIF Ultra test, developed by Cepheid Inc., is designed to detect the genetic material of Mycobacterium tuberculosis, the bacterium that causes TB, in sputum samples.
In addition, it identifies mutations linked to rifampicin resistance, an indicator of multidrug-resistant TB. The test provides results within hours, making it a crucial tool for rapid diagnosis in areas with limited healthcare infrastructure.
WHO Director for Regulation and Prequalification, Dr. Rogerio Gaspar,
highlighted the importance of this development, stating, “High-quality diagnostic tests are the cornerstone of effective TB care and prevention.”
WHO’s prequalification process ensures these tests meet the standards required to improve access to timely and accurate TB diagnoses globally.
In partnership with Singapore’s Health Sciences Authority, WHO’s endorsement of the test reflects its commitment to addressing the burden of TB and drug-resistant TB worldwide. Currently, WHO is assessing seven additional TB tests as part of its ongoing efforts to expand diagnostic options.
