The World Health Organization (WHO) has achieved a significant breakthrough in global health with the prequalification of the Xpert® MTB/RIF Ultra diagnostic test. This marks the first time a tuberculosis (TB) diagnostic test has met the rigorous prequalification standards set by WHO, a development that holds promise for millions affected by this deadly disease.
TB remains one of the world’s most lethal infectious diseases, claiming over a million lives annually and disproportionately affecting low- and middle-income countries. Early and accurate detection of TB, particularly drug-resistant strains, is essential to curbing its spread and improving treatment outcomes.
“This prequalification is a critical milestone in WHO’s mission to accelerate access to high-quality TB diagnostics,” said Dr. Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products. “Groundbreaking tools like this are pivotal in the fight against one of the world’s deadliest infectious diseases.”
Developed by Cepheid Inc., Xpert® MTB/RIF Ultra is a molecular diagnostic test designed to detect Mycobacterium tuberculosis the bacterium responsible for TB directly from sputum samples. It operates on the GeneXpert® Instrument System, providing rapid results within hours. The test also identifies genetic mutations linked to rifampicin resistance, a key marker for multidrug-resistant TB.
This test is particularly beneficial for individuals who test positive for pulmonary TB and have not started anti-TB treatment or received less than three days of therapy within the last six months. By offering quick and reliable results, the test can guide timely and targeted treatment decisions, reducing delays that often worsen patient outcomes.
WHO prequalification assures that diagnostic tools meet stringent international standards for quality, safety, and performance. This certification is vital for countries relying on global procurement mechanisms, ensuring that only high-quality tests are distributed in resource-limited settings.
Prequalification complements WHO’s endorsement approach, which evaluates diagnostics based on evidence of accuracy, patient outcomes, and accessibility. The certification not only builds confidence among healthcare providers but also fosters equitable access to advanced technologies in the fight against TB.
“High-quality diagnostic tests are the cornerstone of effective TB care and prevention,” said Dr. Rogerio Gaspar, WHO Director for Regulation and Prequalification. “This step ensures that countries can address both TB and its drug-resistant variants effectively.”
The prequalification process for Xpert® MTB/RIF Ultra involved collaboration between Cepheid Inc., WHO, and Singapore’s Health Sciences Authority (HSA), the regulatory agency responsible for reviewing the product. This partnership highlights the importance of multi-stakeholder efforts in addressing global health challenges.
Building on this success, WHO is currently assessing seven additional TB diagnostic tests. This ongoing work aims to broaden diagnostic options, improve accessibility, and strengthen the global response to TB.
With the prequalification of Xpert® MTB/RIF Ultra, WHO has taken a crucial step towards enhancing TB care globally. By ensuring the availability of reliable and accessible diagnostics, the organization is empowering healthcare systems to tackle both TB and drug-resistant TB more effectively.
As countries integrate this test into their healthcare systems, the hope is to reduce the devastating impact of TB, saving countless lives and moving closer to the vision of a TB-free world.
