WHO Grants Prequalification to Tuberculosis Diagnostic Test

Tuberculosis, a leading cause of death from infectious diseases globally, is responsible for over a million deaths annually, with particularly devastating effects in low- and middle-income countries.

The World Health Organization (WHO) has granted prequalification to the Xpert® MTB/RIF Ultra, a revolutionary molecular diagnostic test for tuberculosis (TB), marking a significant step in global efforts to combat one of the world's deadliest infectious diseases. This is the first TB diagnostic and antibiotic susceptibility test to meet WHO’s stringent prequalification standards.

Tuberculosis, a leading cause of death from infectious diseases globally, is responsible for over a million deaths annually, with particularly devastating effects in low- and middle-income countries. The emergence of drug-resistant TB strains further complicates diagnosis and treatment, making the need for accurate and timely detection even more urgent.

“The prequalification of this diagnostic test marks a critical milestone in WHO’s efforts to scale up access to high-quality TB tests,” said Dr. Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products. “This groundbreaking tool will help address one of the world’s deadliest infectious diseases by ensuring early and accurate detection.”

Improving Access to High-Quality TB Diagnosis

Prequalification by the WHO ensures that Xpert® MTB/RIF Ultra meets the organization’s rigorous standards for quality, safety, and performance. This approval will facilitate improved access to early diagnosis and treatment for TB patients, particularly in resource-limited settings.

The test, developed by Cepheid Inc., is designed for use on the GeneXpert® Instrument System and utilizes nucleic acid amplification technology to detect the genetic material of Mycobacterium tuberculosis, the bacterium that causes TB. The Xpert® MTB/RIF Ultra can deliver results within hours from sputum samples, identifying not only the presence of TB but also mutations associated with rifampicin resistance, a key marker of multidrug-resistant TB (MDR-TB).

Enhanced Diagnosis for Vulnerable Populations

The Xpert® MTB/RIF Ultra test is specifically aimed at patients who screen positive for pulmonary TB but have either not yet started treatment or have been on treatment for less than three days in the past six months. Its ability to simultaneously detect both TB and drug-resistant strains represents a crucial step forward in managing TB, particularly in areas where drug resistance is prevalent.

“High-quality diagnostic tests are essential for effective TB care and prevention,” said Dr. Rogerio Gaspar, WHO Director for Regulation and Prequalification. “This prequalification opens the door for more equitable access to advanced diagnostic technologies, allowing countries to better tackle the dual challenges of TB and drug-resistant TB.”

Ongoing Efforts to Improve Global TB Diagnosis

WHO’s Global TB Programme, in collaboration with the Department of Regulation and Prequalification, continues to assess and improve access to quality-assured TB tests. In addition to the Xpert® MTB/RIF Ultra, WHO is currently reviewing seven other TB diagnostic tests as part of its ongoing effort to expand diagnostic options for countries in need.

This approval is part of WHO’s broader strategy to combat TB, which includes increasing access to innovative diagnostics and treatments in underserved regions, with a focus on improving patient outcomes and reducing the global TB burden.

The prequalification of Xpert® MTB/RIF Ultra not only marks a significant advance in TB diagnosis but also strengthens global efforts to meet the challenge of multidrug-resistant TB, providing a vital tool in the fight to save millions of lives.