The World Health Organization (WHO) has granted prequalification to Xpert® MTB/RIF Ultra, a molecular diagnostic test for tuberculosis (TB). This marks the first time a TB diagnostic test and antibiotic susceptibility assay has met WHO’s stringent prequalification standards.
TB remains a leading infectious disease killer worldwide, responsible for over a million deaths annually and posing significant socioeconomic challenges, particularly in low- and middle-income countries. Early and accurate detection of TB, including drug-resistant strains, is critical in addressing this global health threat.
“This milestone reflects WHO’s commitment to supporting countries in scaling up access to high-quality TB diagnostics,” said Dr. Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products. “Such innovative tools are essential to combating one of the deadliest infectious diseases.”
The prequalification process ensures the quality, safety, and performance of diagnostic tests. This certification complements WHO’s endorsement approach, which evaluates diagnostic accuracy, patient outcomes, and accessibility, focusing on equity and global health priorities.
The test, developed by Cepheid Inc., underwent rigorous evaluation, including review by Singapore’s Health Sciences Authority (HSA), the regulatory agency of record. Designed for use with the GeneXpert® Instrument System, the Xpert® MTB/RIF Ultra test uses nucleic acid amplification to detect Mycobacterium tuberculosis—the bacterium causing TB—in sputum samples. It also identifies mutations associated with rifampicin resistance, a key marker of multidrug-resistant TB. Results are available within hours, making it a vital tool for timely treatment initiation.
The test is recommended for individuals with suspected pulmonary TB who have not started anti-tuberculosis treatment or received less than three days of therapy in the past six months.
“High-quality diagnostics are the foundation of effective TB care and prevention,” said Dr. Rogerio Gaspar, WHO Director for Regulation and Prequalification. “Prequalification facilitates equitable access to advanced technologies, helping countries tackle TB and drug-resistant TB effectively.”
In collaboration with its Global TB Programme, WHO is currently evaluating seven additional TB diagnostic tests to expand options and enhance access to quality-assured testing globally.
