The World Health Organization (WHO) has achieved a major milestone in the fight against tuberculosis (TB), a disease responsible for 1.25 million deaths last year. The WHO announced its first-ever prequalification of a diagnostic test for TB, the Xpert MTB/RIF Ultra, developed by the U.S.-based molecular diagnostics company Cepheid. In conclusion this groundbreaking test offers a rapid and accurate method to detect TB and assess antibiotic resistance.
What is the Xpert MTB/RIF Ultra?
The Xpert MTB/RIF Ultra identifies the genetic material of the bacteria that causes TB through a simple spit sample. The test provides results within hours, making early detection of TB, including drug-resistant strains, more accessible. WHO previously recommended the test for use, but with prequalification status, global organizations such as UNICEF and the Gavi vaccine alliance can now procure and distribute it more efficiently in resource-limited countries.
Yukiko Nakatani, WHO Assistant Director-General, highlighted the significance of this milestone, stating that it will accelerate access to high-quality TB diagnostic tools. “This is a crucial step toward combating one of the world’s deadliest infectious diseases,” she said.
TB: A Global Health Crisis
Tuberculosis, caused by bacteria, primarily affects the lungs and spreads through airborne particles when infected individuals cough or sneeze. It is both preventable and curable, yet remains a significant global health challenge. In 2023, the WHO recorded 8.2 million new TB cases worldwide, the highest number since the organization began tracking the disease in 1995. With 1.25 million related deaths, TB likely regained its position as the leading cause of death from a single infectious agent, overtaking COVID-19 after a three-year gap.
Impact on High-Burden Countries
The burden of TB is disproportionately concentrated in 30 high-risk countries. Five nations—India, Indonesia, China, the Philippines, and Pakistan—account for over half of the world’s TB cases. India alone bears more than a quarter of these cases. The availability of prequalified diagnostic tests like the Xpert MTB/RIF Ultra could revolutionize TB care in these regions, offering faster diagnosis and improved treatment outcomes.
A Game-Changer for Drug-Resistant TB
One of the most critical challenges in TB care is addressing drug-resistant strains, which complicate treatment and increase mortality rates. Thus the new test’s ability to detect antibiotic resistance ensures timely intervention and appropriate medication, a key factor in controlling the disease’s spread.
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Why Prequalification Matters
WHO prequalification guarantees that a health product meets global standards for quality, safety, and effectiveness. This simplifies the process for international organizations to fund, procure, and deploy the test, particularly in countries with limited healthcare resources.
Rogerio Gaspar, WHO’s Director of Regulation and Prequalification, stressed the importance of such advancements. “High-quality diagnostic tests are the foundation of effective TB care and prevention,” he noted.
A Step Forward in Global Health
The approval of the Xpert MTB/RIF Ultra represents hope for millions affected by TB. By enabling faster, more accurate diagnoses, this innovation could drastically reduce TB-related deaths and slow its global spread. For high-burden countries like Pakistan, where healthcare resources are stretched thin, this test could be a transformative tool in the fight against one of humanity’s oldest diseases.
