The World Health Organization announced Thursday that it has given the green light for the first time to a trial for tuberculosis — a disease that killed 1.25 million people last year.
Xpert MTB/RIF Ultra, manufactured by US-based molecular diagnostics company Cepheid, is “the first test for TB diagnosis and antibiotic susceptibility testing that meets WHO prequalification standards”, the UN health agency said.
WHO prequalification aims to ensure that major health products meet global standards for quality, safety and efficacy.
WHO has already recommended the test, but prequalification means UN agencies like UNICEF, or other agencies like the Gavi vaccine alliance, have a simpler route to purchasing and distributing the product to countries with limited resources.
“This first prequalification of a diagnostic test for tuberculosis supports countries in increasing and accelerating access to high-quality TB tests that meet both WHO recommendations and its rigorous quality, safety and performance standards,” Yukiko said. This is an important milestone in WHO’s efforts to Nakatani, Assistant Director-General of WHO.
“This underscores the importance of such unprecedented diagnostic tools in addressing one of the world’s deadliest infectious diseases.”
TB is a preventable and treatable disease, caused by bacteria and most often affecting the lungs. It spreads through the air when people with pulmonary TB cough, sneeze, or spit.
In October, WHO said a record 8.2 million new tuberculosis cases were diagnosed worldwide in 2023 – the highest number since global TB surveillance began in 1995.
And with 1.25 million related deaths, TB has become the world’s leading cause of death from a single infectious agent, three years after it was replaced by COVID-19, WHO said.
The test detects the genetic material of the bacteria that causes TB in sputum samples, and provides accurate results within a few hours.
WHO says accurate and early detection of TB, especially drug-resistant strains, is a critical global health priority.
“High-quality clinical trials are the cornerstone of effective TB care and prevention,” said Rogério Gaspar, WHO Director of Regulation and Prequalification.
The disease disproportionately affects 30 high-burden countries.
Five countries – India, Indonesia, China, the Philippines and Pakistan – account for more than half the global TB burden, with more than a quarter of cases found in India alone.
(This story has not been edited by NDTV staff and is auto-generated from a syndicated feed.)
