The World Health Organization (WHO) has prequalified Xpert MTB/RIF Ultra, making it the first-ever molecular diagnostic test for tuberculosis (TB) to receive approval. This groundbreaking tool provides improved detection of TB and antibiotic resistance, establishing a new global benchmark for TB care.
The organization attests that the test satisfies its exacting standards for performance, safety, and quality. Its importance is emphasised by WHO Assistant Director-General for Access to Medicines and Health Products Dr. Yukiko Nakatani, who says, “This prequalification reflects our commitment to supporting countries in accessing high-quality TB diagnostics. Accurate and early TB detection is a global health priority.”
How Xpert MTB/RIF Ultra Works
Developed by Cepheid Inc., the Xpert MTB/RIF Ultra test is designed for use with the GeneXpert® system. It utilizes nucleic acid amplification technology to detect Mycobacterium tuberculosis in sputum samples and provides results within hours. The test also identifies mutations linked to rifampicin resistance, a critical indicator of multidrug-resistant TB.
The organization specifies that the test targets individuals who test positive for pulmonary TB and have either not begun treatment or received fewer than three days of therapy in the previous six months.
Paving the Way for Equitable Access
Dr. Rogerio Gaspar, WHO Director for Regulation and Prequalification, emphasizes that prequalification ensures broader access to innovative diagnostic tools. “High-quality diagnostics are essential for effective TB care and prevention, particularly in addressing drug-resistant strains,” he explains.
To increase access to trustworthy and high-quality choices, the organization is also assessing seven more TB diagnostic tests in addition to this one. This initiative is a component of WHO’s plan to improve the global response to tuberculosis and lessen the serious health and socioeconomic effects of the illness.
