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 receive ‘prequalification’ status from the UN health agency, meaning it has passed rigorous quality checks and can now be purchased by governments and United Nations agencies, as part of their efforts to eradicate tuberculosis.
“This first prequalification of a tuberculosis diagnostic test marks a crucial milestone,” said Dr. Yukiko Nakatani, WHO Assistant Director General for Access to Medicines and Health Products. “This highlights the importance of these revolutionary diagnostic tools in combating one of the world’s deadliest infectious diseases.”
Quick results
Accurate results can be expected “within hours”, the WHO said, adding that at the same time as the test is underway, the technology can also identify genetic mutations in patients’ saliva that are associated with resistance to first-line anti-tuberculosis drugs like rifampicin. This result will help doctors offer patients an alternative,”second-line treatmentssuch as bedaquiline and fluoroquinolones – although they are more expensive.
“It is intended for patients who screen positive for pulmonary tuberculosis and who have not started anti-tuberculosis treatment or who have received less than three days of treatment in the last six months,” the health agency said of the United Nations.
Tuberculosis is one of the deadliest infectious diseases in the world, causing more than a million deaths each year. This preventable disease poses a chronic burden for affected people who live primarily in low- and middle-income countries. Accurate and early detection of tuberculosis, particularly drug-resistant strains, remains a critical and challenging global health priority.insisted the WHO.
“High-quality diagnostic tests are the cornerstone of effective TB care and prevention,” said Dr Rogerio Gaspar, WHO Director of Regulatory and Prequalification. “Prequalification paves the way for equitable access to cutting-edge technologies, enabling countries to address the double burden of TB and drug-resistant TB. »
WHO is currently evaluating seven additional tests for tuberculosis with the aim of expanding access to quality-assured testing technology for this disease.
WHO’s assessment for prequalification is based on information submitted by the manufacturer, Cepheid Inc, and a review by the Health Sciences Authority of Singapore.