Chantelle Muzanenhamo
The World Health Organization (WHO) has announced the prequalification of the Xpert® MTB/RIF Ultra, a molecular diagnostic test for tuberculosis (TB) that represents a significant advancement in the fight against one of the world’s most lethal infectious diseases.
This marks the first instance that a test for TB diagnosis and antibiotic susceptibility testing has met WHO’s rigorous prequalification standards.
Tuberculosis remains a leading cause of infectious disease mortality globally, responsible for over a million deaths each year. The disease imposes a considerable socioeconomic toll, particularly impacting low- and middle-income countries. Early and accurate detection of TB, especially in drug-resistant forms, is a vital public health priority.
“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 that meet both WHO recommendations and its stringent quality, safety and performance standards,” said Dr Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products.
“It underscores the importance of such groundbreaking diagnostic tools in addressing one of the world’s deadliest infectious diseases,” he added
The prequalification status of Xpert® MTB/RIF Ultra ensures that diagnostic tests are of high quality, enhancing access to early diagnosis and treatment.
This initiative complements WHO’s endorsement approach, which incorporates emerging evidence, diagnostic accuracy, and patient outcomes, while considering issues of accessibility and equity. Prequalification requirements are centered on quality, safety, and performance.
WHO’s review process for prequalification utilized data submitted by the product’s manufacturer, Cepheid Inc., along with an assessment conducted by Singapore’s Health Sciences Authority (HSA), the regulatory agency responsible for this evaluation.
The Xpert® MTB/RIF Ultra operates on the GeneXpert® Instrument System and employs nucleic acid amplification technology (NAAT) to detect the genetic material of Mycobacterium tuberculosis—the bacterium responsible for TB—in sputum samples. The test delivers results within hours and simultaneously identifies mutations linked to rifampicin resistance, a critical indicator of multidrug-resistant TB. It is specifically designed for patients screened positively for pulmonary TB who have not yet initiated anti-tuberculosis treatment or who have 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 and paves the way for equitable access to cutting-edge technologies, empowering countries to address the dual burden of TB and drug-resistant TB,” he stated
In a concerted effort between the WHO Global TB Programme and the Department of Regulation and Prequalification, WHO is dedicated to enhancing access to quality-assured TB tests and broadening diagnostic options for countries around the globe.
The organization is currently reviewing seven additional TB diagnostic tests, signaling a commitment to further advance TB detection and treatment capabilities.