Tuberculosis
The World Health Organization (WHO) has approved a new test for tuberculosis (TB), called Xpert® MTB/RIF Ultra. This is the first TB test to meet WHO’s strict standards for quality, safety, and performance, and it is expected to play a key role in fighting one of the world’s deadliest infectious diseases.
Why is this important?
TB remains one of the leading causes of death worldwide, killing more than a million people every year. It has a huge impact on both health and economies, especially in low- and middle-income countries. Early and accurate diagnosis of TB, particularly the drug-resistant forms, is essential for controlling the spread of the disease. However, detecting tuberculosis can be challenging, and having reliable tests is critical for saving lives.
What does the new TB test do?
The Xpert® MTB/RIF Ultra test is a fast, accurate way to detect tuberculosis and identify drug-resistant strains of the disease. It works by looking for genetic material from the TB bacteria in a sputum sample (a sample of mucus from the lungs). The test not only diagnoses tuberculosis but also checks for resistance to rifampicin, one of the main drugs used to treat the disease. If a patient has resistance to rifampicin, this could be a sign they have multidrug-resistant tuberculosis, which is harder to treat.
The test can provide results in just a few hours, making it an important tool for doctors to start treatment quickly.
What makes this test special?
This test has been prequalified by WHO, meaning it meets their high standards for quality, safety, and performance. WHO’s prequalification means that health systems can be confident in the accuracy of the test, helping to ensure that people in need get the right diagnosis and treatment.
Dr. Yukiko Nakatani, WHO Assistant Director-General, emphasized the importance of this achievement, calling it a significant milestone in the fight against TB. “It underscores the importance of groundbreaking diagnostic tools in addressing one of the world’s deadliest infectious diseases,” she said.
How will this help fight TB?
Accurate and fast diagnosis is key to controlling TB, especially in areas with high rates of the disease. Xpert® MTB/RIF Ultra test is now prequalified. Wit its help countries can improve TB diagnosis, especially in areas facing a rise in drug-resistant TB. This will help health systems respond faster, prevent disease spread, and improve treatment outcomes.
Dr. Rogerio Gaspar, WHO Director for Regulation and Prequalification, stated, “Prequalification paves the way for equitable access to cutting-edge technologies, empowering countries to address the dual burden of TB and drug-resistant TB.”
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What’s next?
WHO is not stopping here. In collaboration with global TB programs, WHO is working on assessing additional tuberculosis tests to further improve access to quality diagnostics. Right now, seven more tuberculosis tests are being reviewed for prequalification.
This new approval is a crucial step in the global fight against tuberculosis, making it easier for health systems to identify and treat TB, especially drug-resistant forms of the disease, and ultimately saving lives.
Reference
WHO announces first prequalification of a tuberculosis diagnostic test-WHO
