Introduction

In a groundbreaking announcement, the World Health Organization (WHO) has granted prequalification status to the Xpert® MTB/RIF Ultra, a revolutionary molecular diagnostic test for tuberculosis (TB). This landmark achievement marks the first time a TB diagnostic test has met the stringent standards set by WHO, paving the way for enhanced detection and treatment of one of the deadliest infectious diseases worldwide.

The Global Impact of Tuberculosis

Every year, tuberculosis claims over a million lives and poses significant socio-economic challenges, especially in low- and middle-income countries. Early and accurate detection of TB, particularly drug-resistant variants, has been a pressing global health issue and remains a top priority for health systems around the world.

Significance of the Breakthrough

Dr. Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products, emphasized the significance of this milestone: “This first prequalification of a diagnostic test for tuberculosis underscores the necessity for innovative tools in combating one of the world’s deadliest diseases.” The prequalification ensures that the test meets not only WHO’s recommendations but also high standards for quality, safety, and performance.

About the Xpert® MTB/RIF Ultra Test

The Xpert® MTB/RIF Ultra is designed to be used on the GeneXpert® Instrument System. It operates as a nucleic acid amplification test (NAAT), detecting the DNA of Mycobacterium tuberculosis, the bacterium responsible for TB, from sputum samples, providing results within hours. This test is particularly crucial as it can simultaneously identify mutations related to rifampicin resistance, a key sign of multidrug-resistant TB (MDR-TB), making it an essential tool for managing TB treatment effectively.

Target Group for the Test

This test is specifically intended for individuals who have screened positive for pulmonary TB and have either not commenced anti-tuberculosis treatment or have received less than three days of therapy in the preceding six months.

Statements from WHO Officials

Dr. Rogerio Gaspar, WHO’s Director for Regulation and Prequalification, praised the transformation this prequalification brings: “High-quality diagnostic tests are fundamental to effective TB care and prevention. With this step, we are ensuring equitable access to state-of-the-art technologies, enabling countries to tackle both TB and the looming challenge of drug-resistant TB.”

Future Assessments by WHO

In addition to the prequalification of the Xpert® MTB/RIF Ultra, WHO is conducting assessments for an additional seven TB tests with the goal of expanding access to quality-assured diagnostic tools globally.

Conclusion

The WHO’s efforts symbolize a significant leap forward in global health, highlighting the urgent need for improved diagnostics in the fight against tuberculosis, and empowering nations to better manage and ultimately reduce the burden of this formidable infectious disease.