WHO Prequalifies Groundbreaking Test for Tuberculosis Diagnosis
A Milestone in the Global Fight Against One of the World’s Deadliest Diseases
In a landmark move to combat tuberculosis (TB), a leading global health threat, the World Health Organization (WHO) has granted prequalification to the Xpert® MTB/RIF Ultra, a cutting-edge molecular diagnostic test. This momentous decision marks the first time a TB diagnosis and antibiotic susceptibility test has met WHO’s stringent prequalification standards.
Tuberculosis claims over a million lives each year, disproportionately affecting low- and middle-income countries. Effective and timely detection of TB, particularly drug-resistant strains, presents a significant ongoing challenge.
“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,” renowned expert and WHO Assistant Director-General for Access to Medicines and Health Products, Dr. Yukiko Nakatani, commented on the significance of the breakthrough. “It underscores the importance of such groundbreaking diagnostic tools in addressing one of the world’s deadliest infectious diseases.”
The WHO prequalification process is intended to ensure the quality and reliability of diagnostic tests, promoting widespread access to early diagnosis and effective treatment. This approach complements the WHO’s existing endorsement standards, which prioritize emerging evidence, diagnostic accuracy, patient outcomes, accessibility, and equity.
The prequalification of the Xpert® MTB/RIF Ultra is founded on rigorous evaluation conducted by the World Health Organization. This included a comprehensive review of information provided by the manufacturer, Cepheid Inc., and an independent assessment by Singapore’s Health Sciences Authority (HSA), a prominent regulatory agency.
Designed for use with the GeneXpert® Instrument System, the Xpert® MTB/RIF Ultra stands out for its rapid and accurate detection of Mycobacterium tuberculosis, the bacterium responsible for TB, within sputum samples. Crucially, it simultaneously identifies mutations associated with rifampicin resistance – a key indicator of multidrug-resistant TB.
The test is specifically intended for individuals who screen positive for pulmonary TB and have either not begun anti-tuberculosis treatment or have received less than three days of therapy in the past six months.
“High-quality diagnostic tests are the cornerstone of effective TB care and prevention,” emphasized Dr. Rogerio Gaspar, WHO Director for Regulation and Prequalification. “Prequalification paves the way for equitable access to cutting-edge technologies, empowering countries to address the dual burden of TB and drug-resistant TB.”
In a concerted effort to broaden diagnostic options for TB and ensure global access to high-quality tests, the WHO Global TB Programme and the Department of Regulation and Prequalification are currently assessing seven additional TB tests.
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What is the significance of the World Health Organization prequalifying the Xpert® MTB/RIF Ultra test for tuberculosis diagnosis?
## A New Weapon in the Fight Against Tuberculosis
**Host:**
Welcome back to HealthWatch. Today, we’re discussing a major breakthrough in the fight against tuberculosis, a disease that claims over a million lives annually. Joining us is Dr. Alex Reed, an infectious disease specialist, to discuss this exciting development. Dr. Alex Reed, thank you for being here.
**Dr. Alex Reed:**
My pleasure. It’s certainly a remarkable advancement in global health.
**Host:**
For our viewers who may not be familiar, what is tuberculosis and why is this announcement so significant?
**Dr. Alex Reed:**
Tuberculosis, or TB, is a serious infectious disease primarily affecting the lungs. It’s spread through the air when an infected person coughs or sneezes. This prequalification by the World Health Organization (WHO) of the Xpert® MTB/RIF Ultra test is monumental because it’s the first time a TB diagnostic test has met their rigorous quality standards. This means countries around the world can now confidently use this test to diagnose TB and determine if it’s resistant to certain drugs.
**Host:**
Can you elaborate a bit on why this is important for TB diagnosis?
**Dr. Alex Reed:**
Current TB diagnosis methods can be slow and sometimes inaccurate [[1](https://www.uptodate.com/contents/diagnosis-of-pulmonary-tuberculosis-in-adults)]. This new test is quicker, more accurate, and can even detect drug-resistant strains, which is crucial for effective treatment.
**Host:**
Dr. Alex Reed, how will this prequalification by the WHO actually impact the fight against Tuberculosis?
**Dr. Alex Reed:**
This gives healthcare providers access to a tool that will make diagnosing and treating TB more efficient, especially in resource-limited settings where TB is most prevalent. By identifying cases of drug-resistant TB early on, we can prevent further spread and ensure patients receive the right treatment from the start.
**Host:**
This certainly offers a beacon of hope in the global battle against TB. Dr. Alex Reed, thank you for sharing your expertise with us today.
**Dr. Alex Reed:**
My pleasure.