WHO approves first tuberculosis diagnostic test under prequalification standards

• WHO grants its first-ever prequalification for a tuberculosis diagnostic test, Xpert MTB/RIF Ultra
• The test provides accurate results within hours, detecting Mycobacterium tuberculosis and identifying rifampicin resistance
• The test aims to reduce TB’s socio-economic burden and improve patient outcomes in low- and middle-income countries 

The World Health Organization (WHO) has granted its first-ever pre-qualification approval for a tuberculosis (TB) diagnostic test, the Xpert MTB/RIF Ultra. 

The groundbreaking molecular test, developed by Cepheid Inc., a U.S. company, represents a significant advancement in the global fight against TB.

The Xpert MTB/RIF Ultra is the first test for TB diagnosis and antibiotic susceptibility to meet WHO’s stringent pre-qualification standards. The UN health agency announced this on December 5, underscoring the test’s potential to enhance TB diagnosis and treatment globally.

Tuberculosis remains one of the deadliest infectious diseases, causing over a million deaths annually and imposing severe socio-economic challenges, especially in low- and middle-income countries.

Dr Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products, highlighted the critical role of accurate and early detection, particularly for drug-resistant TB strains.

“This prequalification of a TB diagnostic test marks a pivotal milestone in supporting countries to scale up access to high-quality TB assays,” Nakatani stated. 

She emphasised the importance of such tools in combating one of the world’s most lethal diseases.

About the Xpert MTB/RIF Ultra

The Xpert MTB/RIF Ultra test operates on Cepheid’s GeneXpert® Instrument System. It uses nucleic acid amplification technology to detect the genetic material of Mycobacterium tuberculosis, the bacterium responsible for TB, in sputum samples.

The test delivers results within hours, significantly speeding up the diagnostic process. It also identifies genetic mutations linked to rifampicin resistance, a key marker of multidrug-resistant TB.

Designed for individuals who test positive for pulmonary TB and have not undergone more than three days of anti-tuberculosis treatment in the past six months, the test aims to facilitate prompt and accurate diagnosis.

Enhancing global TB response

Dr. Rogerio Gaspar, WHO Director for Regulation and Prequalification, stressed the significance of reliable diagnostics in TB prevention and care.

“Prequalification opens pathways for equitable access to advanced diagnostic technologies, enabling countries to tackle the dual challenges of TB and drug-resistant TB effectively,” Gaspar said.

In collaboration with its Global TB Programme and the Department of Regulation and Prequalification, WHO is currently evaluating seven additional TB tests. These efforts aim to expand diagnostic options and ensure access to quality-assured TB testing tools.

This landmark approval of the Xpert MTB/RIF Ultra is expected to strengthen the global response to TB, particularly in resource-limited settings. It will pave the way for better patient outcomes and reduce the disease burden worldwide.

2024 World AIDS Day: FCT places over 61,000 people on HIV treatment

Meanwhile, TheRadar earlier reported that the Federal Capital Territory (FCT) announced that it successfully placed 61,384 people living with HIV/AIDS (PLHIV) on treatment, exceeding its target by 223%. 

Dr Adedolapo Fasawe, Mandate Secretary for Health Services and Environment Secretariat, FCT Administration, revealed this at a press conference held on Monday, December 2,  in Abuja to commemorate the 2024 World AIDS Day.