WHO announces first prequalification of a tuberculosis diagnostic test

     The World Health Organization (WHO) has prequalified the Xpert® MTB/RIF Ultra molecular diagnostic test for tuberculosis. This is the first tuberculosis diagnostic and antibiotic susceptibility test to meet WHO prequalification criteria.

Tuberculosis is one of the world’s leading killer infectious diseases, killing more than 1 million people each year and causing a huge socioeconomic burden, particularly in low- and middle-income countries. Early and accurate detection of tuberculosis, especially drug-resistant strains, remains a critical and challenging global health priority.

Dr Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products, said: “This first-ever prequalification of a tuberculosis diagnostic test is a major milestone in WHO’s efforts to support countries in scaling up and accelerating access to high-quality tuberculosis tests that meet WHO recommendations and WHO’s stringent quality, safety and performance standards. It is critical that this groundbreaking diagnostic tool is adopted to tackle one of the world’s deadliest infectious diseases.”

WHO’s prequalification of this test helps ensure the quality of diagnostic tests and improve access to early diagnosis and treatment. The WHO approval process is based on emerging evidence, diagnostic accuracy and patient outcomes, taking into account accessibility and equity factors, and the product must meet WHO prequalification requirements for quality, safety and performance.

The WHO prequalification assessment is based on information submitted by the manufacturer, Cepheid, and a review by the Health Sciences Authority of Singapore, the dossier regulator for the product.

The nucleic acid amplification test Xpert® MTB/RIF Ultra, used on the GeneXpert® instrument system, detects genetic material from Mycobacterium tuberculosis (the bacterium that causes TB) in sputum samples and provides accurate results within hours. The test can also be used to identify mutations associated with resistance to rifampicin, a key indicator of multidrug-resistant TB. The test is suitable for patients who have a positive TB screening result and have not started anti-TB treatment or have received less than 3 days of treatment in the past 6 months.

“High-quality diagnostic tests are the cornerstone of effective TB treatment and prevention. They pave the way for equitable access to advanced technologies and strengthen countries’ capacity to address the double burden of TB and drug-resistant TB,” said Dr Rogerio Gaspar, Director of WHO’s Regulatory and Prequalification Department.

To improve access to quality-assured TB tests and expand diagnostic options in countries, WHO is currently evaluating seven additional TB tests, in a joint effort between WHO’s Global TB Programme and the Regulatory and Prequalification Department.