SWITZERLAND—The World Health Organization (WHO) has granted the Xpert® MTB/RIF Ultra prequalification, a molecular diagnostic test for tuberculosis (TB).
This milestone marks the first TB diagnostic and antibiotic susceptibility test to meet WHO’s stringent prequalification standards, ensuring high quality, safety, and performance.
Prequalification is a critical step in improving global access to accurate TB diagnostics and early treatment.
Unlike WHO’s traditional endorsement approach, which focuses on diagnostic accuracy, patient outcomes, and accessibility, the prequalification process requires rigorous quality and safety evaluation.
This ensures that countries can confidently deploy reliable tools to fight TB, one of the deadliest infectious diseases worldwide.
Developed by Cepheid Inc., the Xpert® MTB/RIF Ultra is a nucleic acid amplification test (NAAT) designed for use with the GeneXpert® Instrument System.
It detects the genetic material of Mycobacterium tuberculosis, the bacteria causing TB, in sputum samples. The test provides rapid and precise results within hours.
Moreover, it identifies mutations linked to rifampicin resistance, a key marker of multidrug-resistant TB.
This test is particularly intended for individuals who have tested positive for pulmonary TB and have not started or only recently begun treatment.
The WHO’s assessment of the Xpert® MTB/RIF Ultra relied on data from the manufacturer and a review conducted by Singapore’s Health Sciences Authority, the regulatory body for this product.
Dr. Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products, emphasized that this prequalification represents a significant advancement in global TB care.
“This is a critical milestone in accelerating access to high-quality TB tests that meet WHO’s rigorous standards,” she stated.
Dr. Rogerio Gaspar, WHO Director for Regulation and Prequalification, echoed this sentiment, highlighting the role of reliable diagnostics in combating TB.
“Prequalification opens the door to equitable access to cutting-edge technologies, enabling countries to tackle both TB and drug-resistant TB effectively,” he said.
TB remains a leading cause of death globally, claiming over a million lives annually, with low- and middle-income countries bearing the heaviest burden.
Early and accurate detection of TB, particularly drug-resistant strains, is crucial in controlling the disease.
To expand access to quality TB diagnostics, WHO is currently evaluating seven additional TB tests, reinforcing its commitment to global health equity and innovation.
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