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In an announcement that marks a milestone in the fight against one of the world's deadliest infectious diseases, the World Health Organization (WHO) has prequalified a diagnostic test for tuberculosis (TB) for the first time.
The Xpert® MTB/RIF molecular test Ultra, designed to identify the presence of the bacteria Mycobacterium tuberculosis and its resistance to rifampicin, meets the strict quality, safety and efficacy standards of the WHO.
A global disease with enormous challenges
Tuberculosis remains one of the leading causes of death from infectious diseases, responsible for more than one million deaths annually, and represents a significant socioeconomic burden, especially in low- and middle-income countries.
Early detection of the disease, particularly drug-resistant strains, is a critical challenge that directly impacts the ability of health systems to deliver effective treatment.
Innovation and diagnostic precision
The Xpert® MTB/RIF Ultra test, developed by Cepheid, uses advanced nucleic acid amplification technology to rapidly and accurately detect the bacteria’s genetic material in sputum samples. It also identifies mutations linked to resistance to rifampicin, a key drug in the treatment of multidrug-resistant tuberculosis. Results are available within hours, allowing for timely diagnosis and immediate implementation of treatment strategies.
This tool is designed to Patients with suspected pulmonary tuberculosis who have not yet started treatment or have received less than three days of medication in the last six monthss. Its implementation in the GeneXpert® system offers a comprehensive and efficient solution for healthcare systems in resource-limited environments.
Ensuring quality and accessibility
WHO prequalification ensures that this test meets rigorous international standards, supporting its adoption in low- and middle-income countries.
According to the Dr Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products, this achievement "underlines the importance of innovative diagnostic tools in the fight against tuberculosis."
Ibuprofen Dr. Rogerio Gaspar, Director of Regulatory and Prequalification at WHO, highlighted the importance of high-quality diagnostic tests as a basis for tuberculosis prevention and care, noting that this advance "paves the way towards equitable access to cutting-edge technologies."
A global and continuous effort
This breakthrough is the result of collaboration between the WHO Global Tuberculosis Programme and its Regulatory and Prequalification Department.
In addition to the Xpert® MTB/RIF Ultra, WHO is evaluating seven additional diagnostic tests with the aim of expanding the options available to combat tuberculosis.
The prequalification of this test represents not only a technical advance, but also a key step towards equity in access to health care.
At a time when tuberculosis remains a global threat, this tool offers hope and reinforces WHO's commitment to eradicating this disease.
