NAIROBI, Kenya, Dec 5 – The World Health Organization (WHO) has announced the first prequalification of a tuberculosis (TB) diagnostic and antibiotic susceptibility test.
WHO said Xpert® MTB/RIF Ultra meets its stringent prequalification standards.
Xpert® MTB/RIF Ultra detects the genetic material of Mycobacterium tuberculosis, the bacterium that causes TB, in sputum samples and provides accurate results within hours.
In a statement, Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products, emphasized that the prequalification of this test ensures the quality of diagnostic tools used to improve access to early TB diagnosis and treatment.
Nakatani noted that this complements WHO’s endorsement approach, which prioritizes diagnostic accuracy, patient outcomes, accessibility, and equity while adhering to strict requirements for quality, safety, and performance.
“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,” Nakatani said.
“It underscores the importance of such groundbreaking diagnostic tools in addressing one of the world’s deadliest infectious diseases.”
Identifying mutations
The WHO stated that the Xpert® MTB/RIF Ultra test also identifies mutations associated with rifampicin resistance, a key indicator of multidrug-resistant TB.
The test is designed for patients who test positive for pulmonary TB and have not yet started anti-tuberculosis treatment or received less than three days of therapy in the past six months.
Rogerio Gaspar, WHO Director for Regulation and Prequalification, highlighted the importance of high-quality diagnostic tests in effective TB care and prevention.
“This prequalification paves the way for equitable access to cutting-edge technologies, empowering countries to address the dual burden of TB and drug-resistant TB,” Gaspar said.
He added that WHO, in collaboration with its Global TB Programme and the Department of Regulation and Prequalification, is currently assessing seven additional TB tests to expand diagnostic options for countries.
Tuberculosis remains one of the world’s deadliest infectious diseases, causing over a million deaths annually and imposing significant socioeconomic burdens, especially in low- and middle-income countries. Accurate and early detection, particularly of drug-resistant strains, remains a critical global health challenge.
Kenya reports over 90,000 TB cases annually, according to the National TB Program Annual Report 2023.
On March 5, 2024, the Ministry of Health’s National TB Program Manager, Kathura Immaculate, disclosed that 97,000 TB cases were recorded in 2023 alone.
She underscored the need for targeted interventions to address the TB epidemic, particularly across borders.
