A child receives treatment for malnutrition and pulmonary tuberculosis in Afghanistan. WHO approves ‘revolutionary’ new TB test Health
The World Health Organization (WHO) has approved a potentially “revolutionary” new test for diagnosing tuberculosis (TB), one of the most life-threatening infectious diseases on the planet.
The test, called Xpert MTB/RIF Ultra, uses molecular analysis to detect genetic markers of Mycobacterium tuberculosis, the bacteria that causes tuberculosis, in the saliva of people suspected of being infected.
It is the first test of its kind to be given “prequalified” status by WHO, meaning it has passed rigorous testing and can now be purchased by governments and UN agencies as part of their efforts to fight TB.
“The first prequalification of a diagnostic test for TB marks a major milestone,” said Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products. “It underlines the importance of such innovative diagnostic tools in the fight against one of the world’s deadliest infectious diseases.”
Treatment effectiveness
Accurate test results can be available “within hours,” WHO said, adding that the technology can also identify genetic mutations in saliva that are associated with resistance to key TB drugs such as rifampicin. This will help doctors choose alternative treatments, such as bedaquiline and fluoroquinolones, which are more expensive but may be more effective in certain cases.
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“[The test] is intended for patients who screen positive for pulmonary TB and have either not started anti-TB treatment or have received less than three days of treatment in the past six months,” the WHO says.
Global priority
TB kills more than a million people every year. Those infected – mostly in low- and middle-income countries – suffer from chronic disease. Accurate and early detection of TB, especially drug-resistant strains, remains a global health priority, WHO said.
“High-quality diagnostic tests are essential for effective TB care and prevention,” said Rogerio Gaspar, WHO Director of Regulation and Prequalification. “Prequalification paves the way for equitable access to cutting-edge technologies and empowers countries to address the double burden of TB and drug-resistant TB.”
WHO’s assessment of prequalification is based on information provided by the manufacturer, Cepheid Inc, and a review by the Health Sciences Authority of Singapore. The organization is currently evaluating seven more TB tests to expand access to quality technologies.