The World Health Organization (WHO) prequalifies Xpert MTB/RIF Ultra, marking its first-ever approval of a molecular diagnostic test for tuberculosis (TB). This groundbreaking tool offers enhanced detection of TB and antibiotic resistance, setting a global standard for TB care.
WHO confirms the test meets its stringent criteria for quality, safety, and performance. Dr. Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products, underscores its significance, stating, “Accurate and early TB detection is a global health priority, and this prequalification reflects our commitment to supporting countries in accessing high-quality TB diagnostics.”
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.
WHO 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.
In addition to this approval, WHO is evaluating seven other TB diagnostic tests to expand access to reliable and quality-assured options. This effort forms part of WHO’s strategy to strengthen global TB response and reduce the disease’s significant health and socioeconomic impact.
 prequalifies Xpert MTB/RIF Ultra, marking its first-ever approval of a molecular diagnostic test for tuberculosis (TB). This groundbreaking tool offers enhanced detection of TB and antibiotic resistance, setting a global standard for TB care.){kind=link}