GENEVA (AFP) – The World Health Organization (WHO) announced yesterday it had given a first-ever green light to a test for tuberculosis (TB) – a disease which killed 1.25 million people last year.
Xpert MTB/RIF Ultra, produced by United States (US)-based molecular diagnostics company Cepheid, “is the first test for TB diagnosis and antibiotic susceptibility testing that meets WHO’s prequalification standards”, the UN health agency said. WHO prequalification aims to ensure that key health products meet global standards for quality, safety and efficacy.
The WHO already recommended the test, but prequalification means that United Nations (UN) agencies such as UNICEF, or others like the Gavi vaccine alliance, have a simpler pathway to procure and distribute a product in countries with limited resources.
“This first prequalification of a diagnostic test for tuberculosis marks a critical milestone in WHO’s efforts to support countries in scaling up and accelerating access to high-quality TB assays that meet both WHO recommendations and its stringent quality, safety and performance standards,” said a WHO assistant director-general Yukiko Nakatani. “It underscores the importance of such groundbreaking diagnostic tools in addressing one of the world’s deadliest infectious diseases.”
A preventable and curable disease, TB is caused by bacteria and most often affects the lungs.
