The World Health Organization (WHO) has granted prequalification to Xpert® MTB/RIF Ultra, a molecular diagnostic test for tuberculosis (TB). This is the first TB diagnostic test and antibiotic susceptibility test to meet WHO’s prequalification standards.
Tuberculosis remains one of the world’s leading infectious disease killers, causing over a million deaths annually and placing significant socioeconomic burdens on low- and middle-income countries. Early and accurate detection of TB, particularly drug-resistant strains, is a global health priority.
Dr. Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products, emphasized that this milestone is critical in WHO’s efforts to help countries scale up access to high-quality TB diagnostics that meet stringent quality, safety, and performance standards.
The prequalification of Xpert® MTB/RIF Ultra will ensure the quality of TB diagnostic tools, supporting early diagnosis and treatment. WHO’s assessment process for prequalification includes a review by the Singapore Health Sciences Authority (HSA) and data submitted by the manufacturer, Cepheid Inc.
Xpert® MTB/RIF Ultra, designed for use on the GeneXpert® Instrument System, is a nucleic acid amplification test (NAAT) that detects the genetic material of Mycobacterium tuberculosis, the bacterium responsible for TB, in sputum samples, delivering accurate results in hours.
Simultaneously, the test identifies mutations associated with rifampicin resistance, a key indicator of multidrug-resistant TB.
It is intended for patients who screen positive for pulmonary TB and who have either not started anti-tuberculosis treatment or received less than three days of therapy in the past six months.
“High-quality diagnostic tests are the cornerstone of effective TB care and prevention,” said Dr Rogerio Gaspar, WHO Director for Regulation and Prequalification. “Prequalification paves the way for equitable access to cutting-edge technologies, empowering countries to address the dual burden of TB and drug-resistant TB.”
In a joint effort by the WHO Global TB Programme and the Department of Regulation and Prequalification to improve access to quality-assured TB tests and expand diagnostic options for countries, the WHO is currently assessing seven additional TB tests.
