WHO Grants Prequalification to Molecular Diagnostic Test for Tuberculosis

The WHO has granted “prequalification to the molecular diagnostic test for tuberculosis (TB) called Xpert MTB/RIF Ultra. It is the first test for TB diagnosis and antibiotic susceptibility testing that meets WHO's prequalification standards.”

Tuberculosis causes over a million deaths annually and imposes “immense socioeconomic burdens, especially in low- and middle-income countries.”

WHO’s prequalification assures “quality of diagnostic tests used to improve access to early diagnosis and treatment. It complements WHO’s endorsement approach, which is grounded in emerging evidence, diagnostic accuracy, and patient outcomes alongside considerations for accessibility and equity, with prequalification requirements on quality, safety, and performance.” This particular assessment was based on information submitted by the manufacturer.

The product is a nucleic acid amplification test (NAAT) that “detects the genetic material of Mycobacterium tuberculosis, the bacterium that causes TB, in sputum samples, and provides accurate results within hours. Simultaneously, the test 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.”

WHO is currently assessing seven additional TB tests.