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 “pre-qualification” status from the UN health agency, meaning it has passed strict quality checks and can now be purchased by governments and UN agencies, as part of its tuberculosis eradication efforts.
“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 underlines the importance of such innovative diagnostic tools in tackling 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 performed, 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 alternative “second-line” treatments, such as bedaquiline and fluoroquinolones, even if they are more expensive.
“It is intended for patients who test positive for pulmonary tuberculosis and who have not started anti-tuberculosis treatment or have received less than three days of therapy in the last six months,” the UN health agency said.
Tuberculosis is one of the infectious diseases that causes the most deaths in the world, causing more than a million deaths a year. This preventable disease is a chronic burden for those who suffer from it and live primarily in low- and middle-income countries. Early and accurate detection of tuberculosis, especially drug-resistant strains, remains a critical and challenging global health prioritythe WHO insisted.
“High-quality diagnostic tests are the cornerstone of effective tuberculosis care and prevention,” said Dr Rogerio Gaspar, WHO Director of Regulation and Prequalification. “Prequalification paves the way for equitable access to cutting-edge technologies, empowering countries to address the double burden of tuberculosis and drug-resistant tuberculosis.”
WHO is currently evaluating seven additional tuberculosis tests in an effort to expand access to quality-assured testing technology for the disease.
The WHO assessment for prequalification is based on information submitted by the manufacturer, Cepheid Inc, and a review by the Health Sciences Authority of Singapore.
