The World Health Organization (WHO) has announced that the tuberculosis diagnostic test marks a critical milestone to have met the prequalification standard of the health organization.
WHO made this assertion on Thursday, describing Xpert® MTB/RIF Ultra as the prequalified molecular diagnostic test for tuberculosis (TB) of its first kind.
The notice said, “It is the first test for TB diagnosis and antibiotic susceptibility testing that meets WHO’s prequalification standards.”
WHO reported that a total of 1.25 million people died from tuberculosis (TB) in 2023, and it has been acknowledged as the world’s leading cause of death from a single infectious agent.
Research revealed that in 2023, about 10.8 million people fell ill with TB worldwide: 6.0 million people affected are men, 3.6 million are women, and 1.3 million children.
As one of the world’s leading infectious disease killers, it imposes immense socioeconomic burdens, particularly in low- and middle-income countries.
However, WHO said accurate and early detection of TB, particularly drug-resistant strains, remains a critical and challenging global health priority.
WHO Assistant Director-General for Access to Medicines and Health Products, Dr. Yukiko Nakatani, stated that, “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.”
Nakatani highlighted the significance of this development in addressing one of the world’s deadliest infectious diseases.
WHO’s prequalification of this diagnostic test ensures quality tools for early TB diagnosis and treatment, complementing its endorsement process focused on evidence, accuracy, patient outcomes, and accessibility.
The assessment draws on data from the manufacturer, Cepheid Inc., and a review by Singapore’s Health Sciences Authority (HSA), the regulatory body for this product.
Compatible with the GeneXpert® System, the Xpert® MTB/RIF Ultra test detects Mycobacterium tuberculosis in sputum samples and identifies rifampicin resistance, providing results within hours.
It is intended for pulmonary TB patients who have not started treatment or received less than three days of therapy in the past six months.
Explaining its effectiveness and prevention, the WHO Director for Regulation and Prequalification, Dr. Rogerio Gaspar, said the prequalification grants access to advance technologies, empowering countries to address the dual burden of TB and drug-resistant TB.
The document noted, “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, WHO is currently assessing seven additional TB tests.”
