The World Health Organization (WHO) has approved Xpert MTB/RIF Ultra, a molecular test designed to detect tuberculosis (TB) and assess antibiotic resistance.
This marks the first diagnostic tool for TB to meet WHO’s rigorous prequalification requirements.
The test identifies the genetic material of Mycobacterium tuberculosis in sputum samples, delivering results within hours.
It also detects mutations linked to rifampicin resistance, a key marker for multidrug-resistant TB.
The WHO conducted its assessment based on data submitted and reviewed by Singapore’s Health Sciences Authority.
This approval aims to improve access to reliable diagnostic tools, particularly for patients newly screened for pulmonary TB or those who have not undergone extensive treatment recently.
The introduction of this test is expected to enhance global efforts in diagnosing and managing one of the world’s most deadly infectious diseases.
