The Xpert MTB/RIF Ultra molecular diagnostic test for tuberculosis (TB) has received prequalification from the World Health Organization (WHO). It is the first test that satisfies WHO prequalification requirements for both TB diagnosis and antibiotic susceptibility testing.
One of the most deadly infectious diseases in the world, tuberculosis claims the lives of over a million people each year and has a significant negative socioeconomic impact, particularly in low- and middle-income nations. One of the most important and difficult global health priorities is the accurate and timely detection of tuberculosis, particularly drug-resistant strains.
It is anticipated that this test’s WHO prequalification will guarantee the caliber of diagnostic tests used to increase access to early diagnosis and treatment. With prequalification standards on quality, safety, and performance, it enhances WHO’s endorsement approach, which is based on new data, patient outcomes, and diagnostic accuracy in addition to accessibility and equity considerations.
Based on data provided by Cepheid Inc., the product’s manufacturer, and an evaluation by Singapore’s Health Sciences Authority (HSA), the product’s regulatory body of record, WHO makes its prequalification determination.
This nucleic acid amplification test (NAAT) Xpert MTB/RIF Ultra, which is intended for use with the GeneXpert Instrument System, finds the genetic material of Mycobacterium tuberculosis, the bacterium that causes tuberculosis, in sputum samples and yields precise results in a matter of hours.
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The test also detects mutations linked to rifampicin resistance, which is a crucial sign of multidrug-resistant tuberculosis. Patients who screen positive for pulmonary tuberculosis and have either not begun anti-tuberculosis treatment or have received fewer than three days of therapy within the previous six months are the target population.
“Prequalification paves the way for equitable access to cutting-edge technologies, empowering countries to address the dual burden of TB and drug-resistant TB.
In a joint effort by WHO Global TB Programme and the Department of Regulation and Prequalification to improve access to quality-assured TB tests and expand diagnostic options for countries, WHO is currently assessing seven additional TB tests.
