The World Health Organisation (WHO) has announced its first prequalification of a tuberculosis (TB) diagnostic test, marking a significant breakthrough in tackling one of the deadliest infectious diseases.
The Xpert MTB/RIF Ultra, developed by U.S.-based Cepheid, is now the first TB test to meet WHO’s stringent prequalification standards for quality, safety, and efficacy. While previously recommended by the WHO, prequalification streamlines procurement for UN agencies and organisations such as UNICEF and Gavi, enabling broader distribution to resource-limited countries.
“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,” said Yukiko Nakatani, WHO assistant director-general.
The test detects the genetic material of TB-causing bacteria in spit samples, delivering accurate results within hours. Crucially, it also identifies antibiotic resistance, aiding in early and precise treatment.
Tuberculosis, a preventable and curable disease, remains a major public health challenge. In 2023, 8.2 million new cases were diagnosed worldwide—the highest since 1995, according to WHO data. With 1.25 million deaths, TB likely reclaimed its position as the leading cause of death from a single infectious agent, overtaking COVID-19.
India, Indonesia, China, the Philippines, and Pakistan bear over half the global TB burden, with India alone accounting for more than a quarter of cases.
The WHO’s prequalification of the Xpert MTB/RIF Ultra test paves the way for its widespread adoption in countries most affected by TB. The pre-qualification is expected to support global efforts in scaling up access to effective TB diagnostics, particularly in the 30 high-burden countries disproportionately affected by the disease.
This step brings hope for better management and eventual eradication of TB through early and accurate detection.
