Geneva: The World Health Organization (WHO) has announced the prequalification of the Xpert® MTB/RIF Ultra, a molecular diagnostic test for tuberculosis (TB). This marks the first time a TB diagnostic test and antibiotic susceptibility testing tool has met the WHO’s rigorous prequalification standards, the UN agency revealed in a statement.
According to Anadolu Agency, the WHO emphasized the critical importance of accurate and early TB detection, particularly for drug-resistant strains, which remains a significant global health challenge. Tuberculosis is a leading infectious disease worldwide, causing over a million deaths annually and posing significant socioeconomic challenges, especially in low- and middle-income countries.
Yukiko Nakatani, WHO assistant director-general for access to medicines and health products, highlighted the significance of this development, stating, “This first prequalification of a diagnostic test for tuberculosis marks a critical milestone in WHO’s efforts to support countries i
n scaling up and accelerating access to high-quality TB assays that meet both WHO recommendations and its stringent quality, safety and performance standards.” Nakatani further noted the crucial role of innovative diagnostic tools in combating one of the deadliest infectious diseases globally.
The WHO’s prequalification of the Xpert® MTB/RIF Ultra is anticipated to ensure the quality of TB diagnostic tests, thereby improving access to early diagnosis and treatment, as outlined in the statement.