The World Health Organization (WHO) announced today that it has granted prequalification to a rapid molecular diagnostic test for tuberculosis (TB).
The test, Xpert MTB/RIF Ultra, is a nucleic acid amplification test that detects the genetic material of Mycobacterium tuberculosis in sputum samples and provides results within hours. It also identifies mutations associated with rifampicin resistance, which is a key indicator of multidrug-resistant TB.
WHO prequalification involves product testing, performance evaluation, inspection of manufacturing sites, and other activities aimed at ensuring countries have access to key health products that meet global standards of quality, safety, and efficacy. The WHO's assessment for prequalification of Xpert MTB/RIF Ultra was based on information submitted by the manufacturer, Cepheid Inc., and reviewed by Singapore's Health Sciences Authority.
A 'critical milestone'
The test is the first test for TB diagnosis to meet the WHO's prequalification standards. WHO officials say accurate and early detection of TB, particularly drug-resistant strains, is a 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, MD, PhD, WHO Assistant Director-General for Access to Medicines and Health Products, said in a press release. "It underscores the importance of such groundbreaking diagnostic tools in addressing one of the world's deadliest infectious diseases."
The WHO's most recent annual report on TB shows 8.2 million people were diagnosed with TB in 2023—the highest number of cases recorded by the agency since it began global TB monitoring in 1995. An estimated 400,000 of those cases were multidrug-resistant.