The World Health Organization (WHO) has prequalified the Xpert® MTB/RIF Ultra, a molecular diagnostic test for tuberculosis (TB) and antibiotic resistance.

This landmark approval paves the way for broader access to high-quality tools in the fight against TB, a leading global health threat responsible for over one million deaths annually.

"This marks a critical milestone in scaling up access to high-quality TB diagnostics," said Dr. Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products.

She highlighted the vital role of reliable diagnostic tools in addressing TB, particularly drug-resistant strains that pose an increasingly significant health challenge worldwide.

The Xpert® MTB/RIF Ultra test, designed for use with the GeneXpert® system, detects Mycobacterium tuberculosis in sputum samples and identifies rifampicin resistance within hours.

This rapid diagnosis is crucial for managing untreated or minimally treated pulmonary TB cases.

"High-quality diagnostics are the cornerstone of effective TB care," said Dr. Rogerio Gaspar, WHO Director for Regulation and Prequalification.

WHO's rigorous evaluation process, supported by Singapore's Health Sciences Authority, ensures that the test meets stringent safety and performance standards.

The WHO's approval of the Xpert® MTB/RIF Ultra aligns with its ongoing efforts to improve diagnostic accessibility, particularly in countries like Uganda, where TB remains a significant public health burden.

By enhancing the availability of reliable diagnostics, the WHO aims to strengthen global efforts to combat this deadly disease.