Historic Approval
The World Health Organization (WHO) has declared the prequalification of Xpert MTB/RIF Ultra, a rapid molecular diagnostic test for tuberculosis (TB). Developed by US-based diagnostics company Cepheid, this is the first-ever TB test to meet WHO’s prequalification standards. This accreditation ensures the test’s compliance with global benchmarks for quality, safety, and efficacy, simplifying its procurement and distribution in resource-limited settings.
Importance of Prequalification
Previously endorsed by WHO, the prequalification status allows agencies such as UNICEF and Gavi to expedite their procurement of the test for high-burden areas. Yukiko Nakatani, WHO assistant director-general, described this achievement as a critical step toward expanding access to accurate TB diagnostics in resource-limited settings.
TB’s Global Toll
Impact in 2023: The disease accounted for 1.25 million deaths and 8.2 million new cases, the most ever recorded since 1995.
GlobalBurden:
Five countries—India, Indonesia, China, the Philippines, and Pakistan—account for more than half of the global TB burden, with India alone accounting for more than 25%.
How Xpert MTB/RIF Ultra Works
What it Does:
It detcts Mycobacterium tuberculosis DNA in sputum samples.
Speed:
It gives results witehin hours, which enables timely diagnosis and treatment.
Drug Resistance Detection:
It detects rifampicin resistance, which is a common first-line TB drug. Therefore, it is critical in the management of drug-resistant TB cases.
Accuracy and Efficiency:
Early and proper diagnosis play a critical role in managing TB, particularly multi-drug-resistant TB.
Global Accessibility:
Easy access fosters support for less developed healthcare systems.
Alignment with WHO Goals:
Supports the global strategy of TB elimination by ensuring better detection and increased treatment access.
Global Relevance
Rogerio Gaspar, director of regulation and prequalification at WHO, said that good quality diagnostic tools such as Xpert MTB/RIF Ultra are the backbone of effective TB care and prevention. The disease is still a major public health challenge and disproportionately affects populations in 30 high-burden countries.
This is seen as a breakthrough in the fight against TB, enabling better outcomes through rapid diagnostics and focused treatment strategies.