In a significant breakthrough in the fight against tuberculosis (TB), the World Health Organization (WHO) has endorsed a cutting-edge diagnostic test, marking a milestone in global health.
The test, called Xpert MTB/RIF Ultra, leverages molecular technology to identify the genetic markers of Mycobacterium tuberculosis, the bacterium responsible for TB, using saliva samples from patients.
The test is the first of its kind to achieve “prequalification” status from the WHO. This certification ensures that the diagnostic tool meets rigorous quality standards, allowing governments and UN agencies to procure it as part of their TB eradication programs.
“This first prequalification of a diagnostic test for tuberculosis marks a critical milestone,” 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.”
One of the test’s most remarkable features is its ability to deliver precise results within hours. Alongside confirming TB infection, the technology can detect genetic mutations linked to resistance against first-line TB treatments, such as rifampicin. This allows physicians to quickly tailor alternative treatments, including more advanced but costlier drugs like bedaquiline and fluoroquinolones.
The UN health agency emphasized that the test is designed for patients “who screen positive for pulmonary tuberculosis 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,” noted 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.”
Global Impact and Urgency
Tuberculosis continues to be one of the world’s leading infectious disease killers, claiming over a million lives annually. Most cases occur in low- and middle-income countries, where access to timely and accurate diagnostic tools remains a significant challenge.
Drug-resistant TB presents an even graver threat, requiring more expensive and complex treatment regimens. The ability of the Xpert MTB/RIF Ultra to rapidly identify resistant strains offers a lifeline for patients and healthcare systems burdened by these cases.
The WHO is also evaluating seven additional TB diagnostic tools, highlighting its commitment to expanding the availability of high-quality testing technologies. These initiatives aim to provide accessible and effective solutions for early TB detection, especially in resource-limited settings.
The endorsement of the Xpert MTB/RIF Ultra comes after a thorough evaluation by Singapore’s Health Sciences Authority and information provided by its manufacturer, Cepheid Inc.
“It is intended for patients who screen positive for pulmonary tuberculosis,” WHO stated, adding that its use could transform TB care and significantly reduce mortality rates.
The WHO’s focus on equitable distribution of cutting-edge diagnostic tools like Xpert MTB/RIF Ultra underscores the critical need for global cooperation in combating TB. As nations adopt this test and similar innovations, the hope for eradicating TB inches closer to reality.
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