The World Health Organization (WHO) has announced the prequalification of Xpert MTB/RIF Ultra, a groundbreaking rapid molecular diagnostic test for tuberculosis (TB). This test, developed by Cepheid Inc., is designed to detect Mycobacterium tuberculosis, the bacteria causing TB, and mutations linked to rifampicin resistance, a marker of multidrug-resistant TB (MDR-TB). The test delivers accurate results within hours, making it a critical tool for early diagnosis and effective treatment.
Why Is This Test Important?
Tuberculosis is one of the deadliest infectious diseases, claiming over a million lives each year. The burden is especially heavy in low- and middle-income countries, where access to quality healthcare is often limited. Early and accurate diagnosis of TB, particularly drug-resistant strains, is crucial to saving lives and reducing the socioeconomic impact of the disease.
WHO’s prequalification ensures that the Xpert MTB/RIF Ultra meets stringent quality, safety, and performance standards. This milestone is part of WHO’s mission to make high-quality TB diagnostic tools accessible globally, addressing the urgent need for better TB care and prevention.
Key Features of Xpert MTB/RIF Ultra
- Rapid Results: Delivers accurate diagnostic results within hours.
- Dual Functionality: Detects Mycobacterium tuberculosis and mutations linked to rifampicin resistance.
- Advanced Technology: Uses nucleic acid amplification testing (NAAT) to identify the genetic material of TB bacteria.
- Patient-Centric: Designed for patients with pulmonary TB who have not started or recently begun treatment.
This test is compatible with the GeneXpert® Instrument System, a widely used platform for molecular diagnostics.
What Does WHO Prequalification Mean?
WHO prequalification assures that diagnostic tools meet international standards for quality, safety, and performance. It ensures that countries can access reliable and evidence-based technologies to enhance TB diagnosis and treatment.
According to Dr. Yukiko Nakatani, WHO Assistant Director-General, this milestone represents a step forward in addressing one of the world’s deadliest diseases. Prequalification supports equitable access to advanced tools, enabling healthcare providers to deliver better outcomes for patients.
Impact on TB and Drug-Resistant TB
The Xpert MTB/RIF Ultra test is expected to:
- Improve early detection of TB and drug-resistant strains.
- Enhance treatment outcomes by identifying the right course of action early.
- Support global health efforts in combating TB, especially in high-burden areas.
Dr. Rogerio Gaspar, WHO Director for Regulation and Prequalification, emphasized the importance of high-quality diagnostic tests in fighting TB. He noted that prequalification ensures equitable access to cutting-edge technologies, empowering countries to tackle the dual burden of TB and MDR-TB.
A Collaborative Effort
This prequalification is part of a broader effort by the WHO Global TB Programme and the Department of Regulation and Prequalification to expand diagnostic options and improve access to quality-assured TB tests. WHO is currently assessing seven additional TB tests to further support global efforts against TB.
Conclusion
The pre-qualification of the Xpert MTB/RIF Ultra marks a significant advancement in the global fight against tuberculosis. With its ability to rapidly and accurately detect TB and rifampicin resistance, this test represents a cornerstone of effective TB care and prevention. By making cutting-edge diagnostic tools accessible, WHO continues to lead the way in improving global health and addressing the challenges posed by TB and drug-resistant TB.
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