The World Health Organization has endorsed the prequalification of the Xpert MTB/RIF Ultra, a molecular diagnostic test for tuberculosis. This marks the first TB test approved for both disease diagnosis and antibiotic susceptibility testing, adhering to WHO’s rigorous prequalification criteria.
Tuberculosis ranks among the top global infectious disease threats, responsible for over a million deaths each year and significantly impacting societal and economic structures, particularly in low- and middle-income nations. Ensuring accurate and prompt detection of TB, especially its drug-resistant variants, remains a pivotal and difficult challenge in global health efforts.
“This prequalification milestone for a TB diagnostic test signifies a vital step in WHO’s mission to help countries enhance and expedite access to high-quality TB diagnostics that align with WHO directives and uphold strict quality, safety, and performance benchmarks,” stated Dr. Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products. “It highlights the crucial role of such innovative diagnostic solutions in combatting one of the most lethal infectious diseases worldwide.”
The WHO prequalification is expected to guarantee the reliability of diagnostic tests, facilitating better early diagnosis and treatment access. It complements the WHO’s approval process, focusing on emerging evidence, diagnostic precision, and patient results, while considering accessibility and fairness, with prequalification stipulations on quality, safety, and efficacy.
WHO’s prequalification process relies on manufacturer submissions, which in the case of this product was provided by Cepheid Inc, and reviewed by Singapore’s Health Sciences Authority, the designated regulation authority.
This nucleic acid amplification test, used in conjunction with the GeneXpert Instrument System, detects Mycobacterium tuberculosis, the bacteria responsible for TB, in sputum samples, delivering precise results in a matter of hours. Simultaneously, the test identifies mutations linked to resistance against rifampicin, a critical marker for multidrug-resistant TB.
The test is intended for patients with a positive TB screening who have either not yet begun anti-tuberculosis therapy or have undergone less than three days of treatment within the preceding six months.
“The foundation of effective TB care and prevention lies in top-tier diagnostic tests,” commented Dr. Rogerio Gaspar, WHO Director for Regulation and Prequalification. “Prequalification facilitates equitable access to groundbreaking technologies, equipping nations to tackle the dual challenges of TB and drug-resistant TB more effectively.”
Through a collaborative initiative of the WHO Global TB Programme and the Department of Regulation and Prequalification, aimed at improving access to high-quality TB tests and broadening diagnostic selections for nations, WHO is currently evaluating seven more TB tests.