The test – called Xpert MTB/RIF Ultra – uses molecular analysis to detect genetic markers of Mycobacteria tube, the bacteria that cause tuberculosis, in the saliva of people suspected of infection.
It is the first test to receive “pre-qualification” status from the United Nations health agency, meaning it has passed rigorous quality checks and can now be used by governments and United Nations agencies. National purchased as part of their tuberculosis eradication efforts.
“This first prequalification of a tuberculosis diagnostic test marks an important milestone,” said Dr. Yukiko Nakatani. WHO Assistant Director General for Access to Medicines and Health Products. “It highlights the importance of such groundbreaking diagnostic tools in tackling one of the world’s deadliest infectious diseases.”
Fast results
Accurate results can be obtained “within hours,” WHO said, adding that at the same time as testing, the technology can also identify genetic mutations in a patient’s saliva that may related to tuberculosis. resistant to first-line tuberculosis drugs like rifampicin. These results will help doctors offer alternative options to patients.”second-line treatment”such as bedaquiline and fluoroquinolones – although they are more expensive.
“It is for patients who screen positive for pulmonary tuberculosis and have not started anti-tuberculosis treatment or have had treatment for less than three days in the past six months,” the UN health agency said.
Tuberculosis is one of the world’s leading infectious disease killers, causes more than one million deaths each year. This preventable disease is a chronic burden for sufferers primarily living in low- and middle-income countries. Early and accurate detection of tuberculosis, especially drug-resistant strains, remains an important and challenging global health priority.WHO emphasized.
“High-quality diagnostic tests are the foundation of effective tuberculosis care and prevention,” said Dr. Rogerio Gaspar, Director of Regulations and Prequalification at WHO. “Prequalification paves the way for equitable access to innovative technologies, empowering countries to address the dual burden of tuberculosis and drug-resistant tuberculosis.”
WHO is currently evaluating seven additional TB tests in an effort to expand access to quality-assured TB testing technology.
WHO’s assessment of the prequalification is based on information provided by the manufacturer Cepheid Inc and an assessment by the Singapore Health Sciences Authority.
