WHO announces 1st prequalification of tuberculosis diagnostic test

GENEVA

The World Health Organization (WHO) on Thursday announced that it granted prequalification to the molecular diagnostic test for tuberculosis (TB) called Xpert®️ MTB/RIF Ultra.

It is the first test for TB diagnosis and antibiotic susceptibility testing that meets WHO's prequalification standards, the UN agency said in a statement.

Tuberculosis is one of the world’s leading infectious disease killers, causing over a million deaths annually and imposing immense socioeconomic burdens, especially in low- and middle-income countries, it said.

According to the WHO, accurate and early detection of TB, especially drug-resistant strains, remains a critical and challenging global health priority.

"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," Yukiko Nakatani, WHO assistant director-general for access to medicines and health products, said.

"It underscores the importance of such groundbreaking diagnostic tools in addressing one of the world's deadliest infectious diseases," Nakatani added.

WHO prequalification of this test, the statement said, is expected to "assure quality of diagnostic tests used to improve access to early diagnosis and treatment."