The World Health Organization (WHO) on 5 December announced that it 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 is one of the world’s leading infectious disease killers, causing over a million deaths annually and imposing immense socioeconomic burdens, especially in low- and middle-income countries.
- Accurate and early detection of TB, especially drug-resistant strains, remains a critical and challenging global health priority.
- WHO prequalification of this test is expected to assure 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.
- WHO’s assessment for prequalification is based on information submitted by the manufacturer, Cepheid Inc., and the review by Singapore’s Health Sciences Authority (HSA), the regulatory agency of record for this product.
