WHO announces first prequalification of a tuberculosis diagnostic test

Realistic background with microscopic views of various colorful virus cells vector illustration

0 0
Read Time:2 Minute, 9 Second

The World Health Organization (WHO) has granted prequalification to the molecular diagnostic test for tuberculosis (TB) called Xpert® MTB/RIF Ultra. It is the first test for TB diagnosis and antibiotic susceptibility testing that meets WHO’s prequalification standards.

 

Tuberculosis is one of the world’s leading infectious disease killers, causing over a million deaths annually and imposing immense socioeconomic burdens, especially in low- and middle-income countries. Accurate and early detection of TB, especially drug-resistant strains, remains a critical and challenging global health priority.

 

“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 that meet both WHO recommendations and its stringent quality, safety and performance standards,” said Dr Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products. “It underscores the importance of such groundbreaking diagnostic tools in addressing one of the world’s deadliest infectious diseases.”

 

WHO prequalification of this test is expected to assure quality of diagnostic tests used to improve access to early diagnosis and treatment. It complements WHO’s endorsement approach, which is grounded in emerging evidence, diagnostic accuracy, and patient outcomes alongside considerations for accessibility and equity, with prequalification requirements on quality, safety, and performance.

 

WHO’s assessment for prequalification is based on information submitted by the manufacturer, Cepheid Inc., and the review by Singapore’s Health Sciences Authority (HSA), the regulatory agency of record for this product.

 

Designed for use on the GeneXpert® Instrument System, this nucleic acid amplification test (NAAT) Xpert® MTB/RIF Ultra detects the genetic material of Mycobacterium tuberculosis, the bacterium that causes TB, in sputum samples, and provides accurate results within hours. Simultaneously, the test identifies mutations associated with rifampicin resistance, a key indicator of multidrug-resistant TB.

It is intended for patients who screen positive for pulmonary TB and who have either not started anti-tuberculosis treatment or 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,” said 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 joint effort by WHO Global TB Programme and the Department of Regulation and Prequalification to improve access to quality-assured TB tests and expand diagnostic options for countries, WHO is currently assessing seven additional TB tests.

 

World Health Organization

Happy
Happy
0 %
Sad
Sad
0 %
Excited
Excited
0 %
Sleepy
Sleepy
0 %
Angry
Angry
0 %
Surprise
Surprise
0 %

About Author

You may have missed

Lusaka — African health ministers and partners are calling for increased investment in integrated health services to address the growing burden of severe noncommunicable diseases (NCDs), particularly those affecting women and underserved populations across the region. At a high-level side event during the Seventy-fifth session of the WHO Regional Committee for Africa, delegates emphasized the urgent need for equitable access to prevention, screening, treatment, and rehabilitation across the continuum of care for NCDs. Disparities are especially pronounced in rural areas, where health infrastructure and services remain inadequate. Breast and cervical cancers are among the leading causes of cancer-related deaths among women in sub-Saharan Africa—particularly cervical cancer, which is both preventable and treatable. It remains the most common cause of cancer death for women in the region. In 2022, Africa accounted for nearly a quarter (23%) of the 76 000 global cervical cancer deaths. Meanwhile, severe NCDs such as Type 1 diabetes, sickle cell disease, and heart conditions claim more than half a million lives annually, including among children, adolescents, and young adults in some of the continent’s poorest communities. Inequitable access to health services continues to hinder efforts to reduce this burden. To improve cervical and breast cancer care in the region, urgent investment is needed in leadership, governance, and financing. Strengthening these foundations is critical in the current funding landscape. Advancements in strategic planning, healthcare infrastructure, workforce training, and—most importantly—equitable access to screening, diagnostic, and treatment services are essential. To address these challenges, WHO and its partners showcased successful integrated models such as the Women’s Integrated Care for Cancer Services (WICS), the BEAT Breast Cancer Project, and the PEN-Plus Strategy. WICS strengthens early detection, treatment, and integration of women’s cancer services into primary health care systems in Côte d’Ivoire, Kenya, and Zimbabwe. The BEAT Breast Cancer Project is a transformative multi-year initiative aimed at reducing breast cancer mortality among women in Tanzania and Ghana through early detection, timely diagnosis, and comprehensive treatment access. “PEN-Plus, WICS and the BEAT Breast Cancer Initiative are models for a new standard of care, rooted in equity, access and health justice. I urge countries to prioritize policies that embed these models into broader health system strengthening, said Dr Mohamed Janabi, WHO Regional Director for Africa”. Côte d’Ivoire offers a compelling example of progress, combining high HPV vaccination coverage—reaching over three million girls (91.4%)—with WICS-supported community-based screening campaigns to strengthen cervical cancer prevention. In Kenya, cervical cancer screening has been successfully integrated into national health services. “This gathering marks a pivotal moment to accelerate action for breast cancer prevention in Africa. We deeply value the leadership of the Ministries of Health of Ghana and Tanzania, and the steadfast support of the Pfizer Foundation in helping us achieve this milestone. The side event builds momentum for the policy prioritization of women’s cancers, partnerships to strengthen the broader women’s cancer ecosystem, and advance a health-systems approach to breast cancer prevention and management”, said Dr Somesh Kumar, Senior Director, Jhpiego. PEN-Plus expands access to care for severe NCDs at the district hospital level. Since its implementation, 20 countries in Africa have increased access to services for severe NCDs. Over 15 000 people are currently receiving treatment for chronic conditions such as sickle cell disease and Type 1 diabetes through PEN-Plus clinics.