The WHO’s approval of Xpert MTB/RIF Ultra revolutionizes TB diagnostics, offering rapid detection and drug-resistance testing to advance global health efforts.
In a groundbreaking advancement for global health, the World Health Organization (WHO) has prequalified the Xpert MTB/RIF Ultra, a diagnostic test designed for rapid tuberculosis (TB) detection and drug resistance analysis.
This first-ever approval of a TB diagnostic test under WHO’s stringent prequalification standards is set to revolutionize efforts against the disease, which claims over 1.25 million lives annually.
Revolutionizing TB Diagnostics with Xpert MTB/RIF Ultra
Manufactured by Cepheid Inc., the Xpert MTB/RIF Ultra test leverages the GeneXpert® Instrument System to detect the DNA of Mycobacterium tuberculosis in sputum samples within hours.
Its ability to identify rifampicin resistance, a marker for multidrug-resistant TB (MDR-TB), makes it indispensable in fighting this global epidemic.
Dr. Yukiko Nakatani, WHO Assistant Director-General, praised the milestone, stating:
“This prequalification supports countries in scaling up access to high-quality TB diagnostic tools that meet global standards.”
The rigorous evaluation, in partnership with Singapore’s Health Sciences Authority, confirmed the test’s compliance with stringent safety and performance criteria. Dr. Rogerio Gaspar, WHO Director for Regulation, emphasized:
“Prequalification ensures equitable access to advanced technologies, enabling countries to combat TB effectively.”
Despite the progress, TB remains a formidable challenge, with over 8.2 million new cases diagnosed in 2023, the highest recorded since monitoring began in 1995.
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