The World Health Organization (WHO) announced on Thursday that it has approved a tuberculosis (TB) test for the first time, which comes after TB claimed the lives of 1.25 million people last year.
The Xpert MTB/RIF Ultra, developed by the US molecular diagnostics company Cepheid, is the first TB test to meet WHO’s prequalification standards. This test is designed to diagnose TB and assess antibiotic resistance.
WHO prequalification ensures that important health products meet global quality, safety, and efficacy standards. While the test had already been recommended by WHO, prequalification makes it easier for UN agencies, such as UNICEF and the Gavi vaccine alliance, to procure and distribute it in low-resource countries.
“This prequalification marks a significant milestone in WHO’s effort to help countries expand access to quality TB diagnostics that meet both WHO’s guidelines and rigorous safety and performance standards,” said Yukiko Nakatani, a WHO assistant director-general. “It highlights the role of such innovative diagnostic tools in combating one of the world’s deadliest infectious diseases.”
Tuberculosis, which is preventable and treatable, is caused by bacteria that primarily affect the lungs and spread through the air when infected individuals cough, sneeze, or spit.
In October, the WHO reported that a record 8.2 million new TB cases were diagnosed globally in 2023, the highest number since it began monitoring TB in 1995. With 1.25 million deaths, TB has likely regained its position as the world’s leading infectious killer, surpassing COVID-19, which had been the leading cause of death for the past three years.
The test works by detecting the genetic material of the TB-causing bacteria in saliva samples, providing results within hours. WHO emphasizes that early and accurate TB diagnosis, particularly of drug-resistant strains, is crucial for global health.
“Reliable diagnostic tests are fundamental for effective TB treatment and prevention,” said Rogerio Gaspar, WHO’s director of regulation and prequalification.
TB disproportionately affects 30 high-burden countries. India, Indonesia, China, the Philippines, and Pakistan account for over half of the global TB burden, with India alone responsible for more than a quarter of all cases.
