WHO has prioritized the first TB diagnostic test.

ISLAMABAD: The World Health Organization (WHO) has granted pre-qualification approval to the Expert MTB/RIF Ultra, a leading molecular diagnostic test for tuberculosis (TB), a deadly disease. An important milestone in the global fight against one of the most infectious diseases.

It is the first diagnostic test for TB and drug resistance testing to meet WHO’s stringent pre-qualification criteria. Tuberculosis remains a leading cause of death worldwide, accounting for more than one million deaths annually, and imposes a significant health and economic burden, particularly in low- and middle-income countries such as Pakistan.

The introduction of Xpert MTB/RIF Ultra is expected to boost TB control efforts in Pakistan, which has the fifth highest TB burden globally, experts said on Thursday. This nucleic acid amplification test (NAAT) detects the genetic material of Mycobacterium tuberculosis in sputum samples within hours. It also identifies mutations associated with rifampicin resistance, an important indicator of multidrug-resistant TB (MDR-TB). By providing rapid and accurate results, the test addresses significant challenges in early detection of TB and its resistant forms. WHO emphasized the importance of this diagnostic progress, highlighting its potential to strengthen health systems. “This first prequalification of a TB diagnostic test marks an important milestone in WHO’s efforts to help countries increase access to high-quality TB assays,” said Dr. Yukiko Nakatani, WHO Asst. Director General for Access to Medicines and Health Products said. He added that this innovation will play an important role in combating one of the world’s deadliest infectious diseases.

The test, developed by Cepheid Inc., underwent rigorous review by the WHO, including review by the Health Sciences Authority of Singapore. Designed for use with the GeneXpert® instrument system, this test can diagnose TB in patients who screen positive for pulmonary TB and who have received more than three days of anti-TB treatment in the past six months. Not taken. Dr. Rogerio Gaspar, WHO Director for Regulation and Prequalification, described the test as a cornerstone for effective TB care and prevention, saying, “Prequalification paves the way for equitable access to advanced technology, Empowering countries to address the dual burden of TB and drug-resistant TB.”

In Pakistan, where millions of TB cases are reported annually, this test offers a promising solution to ongoing diagnostic challenges. Traditional methods such as microscopy and culture-based testing are time-consuming and less sensitive, especially for detecting low bacterial loads and drug resistance. The Xpert MTB/RIF Ultra Test is designed to overcome these limitations by providing faster and more reliable results. Experts say that for Pakistan, integrating Xpert MTB/RIF Ultra into the National TB Control Program can accelerate efforts to combat TB and MDR-TB. Early and accurate detection is critical to reducing transmission, initiating timely treatment, and achieving the country’s goal of eliminating TB as a public health threat by 2030.

Test pre-qualification complements WHO’s broader TB strategy, which includes validating emerging diagnostic tools and addressing issues of equity and access. Additionally, WHO is currently evaluating seven other TB diagnostic tests to further expand diagnostic options globally.