The World Health Organization (WHO) has granted prequalification to the Xpert® MTB/RIF Ultra molecular diagnostic test, making it the first tuberculosis (TB) diagnostic and antibiotic susceptibility test to meet WHO’s stringent prequalification standards. This marks a pivotal step toward enhancing global TB detection and treatment.
The Global Burden of Tuberculosis
Tuberculosis remains one of the deadliest infectious diseases worldwide, causing over one million deaths annually and disproportionately impacting low- and middle-income countries. The disease not only poses severe health challenges but also imposes significant socioeconomic burdens. Early and accurate diagnosis, particularly for drug-resistant TB strains, is a cornerstone of effective global TB management yet remains a persistent challenge.
Significance of WHO Prequalification
“This first prequalification of a TB diagnostic test represents a critical milestone in supporting countries to scale up access to high-quality diagnostic tools,” said Dr. Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products. She emphasized that groundbreaking diagnostic solutions like Xpert® MTB/RIF Ultra are vital for combating one of the world’s most lethal infectious diseases.
Prequalification by WHO ensures the test meets rigorous standards for quality, safety, and performance, providing countries with confidence in its reliability. It complements WHO’s broader efforts to endorse tools based on evidence of diagnostic accuracy, patient outcomes, accessibility, and equity.
About the Xpert® MTB/RIF Ultra
Developed by Cepheid Inc., Xpert® MTB/RIF Ultra is designed for use with the GeneXpert® Instrument System. This nucleic acid amplification test (NAAT) detects the genetic material of Mycobacterium tuberculosis—the bacterium responsible for TB—in sputum samples. Results are delivered within hours, allowing for rapid diagnosis.
In addition to detecting TB, the test identifies genetic mutations linked to rifampicin resistance, a hallmark of multidrug-resistant TB. This dual capability makes the test particularly valuable for identifying patients who may require specialized treatments.
The test is intended for patients who test positive for pulmonary TB and have not yet started anti-TB treatment or have received less than three days of therapy within the last six months.
Role in Expanding Global TB Care
Dr. Rogerio Gaspar, WHO Director for Regulation and Prequalification, highlighted the transformative potential of such advancements: “High-quality diagnostic tests are the foundation of effective TB care and prevention. Prequalification facilitates equitable access to cutting-edge technologies, enabling countries to tackle both TB and drug-resistant TB more effectively.”
By providing rapid and reliable results, the Xpert® MTB/RIF Ultra test aligns with global efforts to reduce the diagnostic delay that hinders timely treatment. Early detection is critical to breaking the chain of TB transmission and improving outcomes for affected individuals.
Collaborative Efforts
The WHO prequalification process involved collaboration with Singapore’s Health Sciences Authority (HSA), the regulatory body of record for the test. The rigorous assessment included a review of information submitted by the manufacturer, ensuring the product’s compliance with WHO’s high standards.
This milestone reflects a joint effort between WHO’s Global TB Programme and the Department of Regulation and Prequalification. These teams are actively working to expand diagnostic options and improve access to quality-assured TB tests worldwide. In addition to the Xpert® MTB/RIF Ultra, WHO is currently evaluating seven other TB diagnostic tests to broaden the range of tools available for combating the disease.
