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WHO announces the first requalification of a diagnostic test for tuberculosis
The World Health Organization (WHO) has granted prequalification to a molecular diagnostic test for tuberculosis (TB) called Xpert® MTB/RIF Ultra. It is the first test for tuberculosis diagnosis and antibiotic susceptibility testing that meets WHO prequalification standards.
Tuberculosis is one of the world's leading infectious disease killers, causing more than a million deaths annually and imposing enormous socioeconomic burdens, particularly in low- and middle-income countries. Accurate and early detection of tuberculosis, especially drug-resistant strains, remains a critical and challenging global health priority.
“This first pre-qualification of a TB diagnostic test marks a key milestone in WHO's efforts to support countries in increasing and accelerating access to high-quality TB tests that meet both WHO recommendations and its strict standards of quality, safety and efficacy,” said Dr. Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products. “This underscores the importance of such revolutionary diagnostic tools in addressing one of the world's deadliest infectious diseases.”
WHO prequalification for this test is expected to ensure the quality of diagnostic tests used to improve access to early diagnosis and treatment. It complements the WHO approval approach, which is based on new evidence, diagnostic accuracy and patient outcomes, together with considerations of affordability and equity, with pre-qualification requirements on quality, safety and performance.
WHO's prequalification assessment is based on information provided by the manufacturer, Cepheid Inc., and review by the Health Sciences Authority of Singapore (HSA), the regulatory agency for this product.
Designed for use on the GeneXpert® Instrument System, this Xpert® MTB/RIF Ultra Nucleic Acid Amplification Test (NAAT) detects genetic material Mycobacterium tuberculosisbacteria that causes TB, in sputum samples and gives accurate results within hours. At the same time, the test identifies mutations associated with resistance to rifampicin, a key indicator of multidrug-resistant tuberculosis.
It is intended for patients who are positive for pulmonary TB and who have either not started anti-tuberculosis therapy or have received less than three days of therapy in the last six months.
“High-quality diagnostic tests are the cornerstone of effective tuberculosis care and prevention,” said Dr. Rogerio Gaspar, WHO Director of Regulation and Retraining. “Prequalification paves the way for equal access to cutting-edge technologies, empowering countries to address the dual burden of TB and drug-resistant TB.”
In a joint effort by the World Health Organization's World Tuberculosis Program and the Department of Regulation and Requalification to improve access to quality tuberculosis tests and expand diagnostic options for countries, WHO is currently evaluating seven additional tuberculosis tests.
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