WHO Okays First-ever Prequalified TB Diagnostic Test

The World Health Organisation (WHO), on Thursday, announced that it has granted prequalification to the molecular diagnostic test for tuberculosis, called Xpert MTB/RIF Ultra.

The WHO said in a statement that it is the first test for TB diagnosis and antibiotic susceptibility testing that meets its prequalification standards.

The WHO Assistant Director-General for Access to Medicines and Health Products, Dr Yukiko Nakatani, said accurate and early detection of TB, especially drug-resistant strains, remains a critical and challenging global health priority.

“This first prequalification of a diagnostic test for tuberculosis marks a critical milestone in WHO’s efforts to support countries in scaling up and accelerating access to high-quality TB assays that meet both WHO recommendations and its stringent quality, safety, and performance standards.

“It underscores the importance of such groundbreaking diagnostic tools in addressing one of the world’s deadliest infectious diseases,” Nakatani said.

The WHO explained that Xpert® MTB/RIF Ultra detects the genetic material of Mycobacterium tuberculosis, the bacterium that causes TB, in sputum samples, and provides accurate results within hours.

The WHO’s assessment for prequalification was based on information submitted and the review by Singapore’s Health Sciences Authority (HSA).

The test also identifies mutations associated with rifampicin resistance, a key indicator of multidrug-resistant TB.

“It is intended for patients who screen positive for pulmonary TB and who have either not started anti-tuberculosis treatment or received less than three days of therapy in the past six months,” the agency emphasised.

The WHO Director for Regulation and Prequalification, Dr Rogerio Gaspar, said that high-quality diagnostic tests are the cornerstone of effective TB care and prevention.

“Prequalification paves the way for equitable access to cutting-edge technologies, empowering countries to address the dual burden of TB and drug-resistant TB,” he stated.