The World Health Organization (WHO) has granted prequalification to the molecular diagnostic test for tuberculosis (TB) called Xpert MTB/RIF Ultra. It is the first test for TB diagnosis and antibiotic susceptibility testing that meets WHO's prequalification standards.
WHO’s assessment for prequalification is based on information submitted by the manufacturer, Cepheid Inc., and the review by Singapore’s Health Sciences Authority (HSA), the regulatory agency of record for this product.
Designed for use on the GeneXpert Instrument System, this nucleic acid amplification test (NAAT) Xpert MTB/RIF Ultra detects the genetic material of Mycobacterium tuberculosis, the bacterium that causes TB, in sputum samples, and provides accurate results within hours. Simultaneously, the test identifies mutations associated with rifampicin resistance, a key indicator of multidrug-resistant TB.
It is intended for patients who screen positive for pulmonary TB and who have either not started anti-tuberculosis treatment or received less than three days of therapy in the past six months.
