The World Health Organization (WHO) has granted prequalification to Cepheid’s molecular diagnostic tuberculosis (TB) test.
The Xpert MTB/RIF Ultra test is the first test for TB diagnosis and antibiotic susceptibility testing to meet WHO's prequalification standards, WHO said in a statement. The organization’s assessment for prequalification was based on information submitted by Cepheid and a review by Singapore’s Health Sciences Authority (HSA), the regulatory agency of record for the test.
The Xpert MTB/RIF Ultra test is a nucleic acid amplification test (NAAT) designed for use on Cepheid’s GeneXpert Instrument System; according to WHO, it detects the genetic material of Mycobacterium tuberculosis, the bacterium that causes TB, in sputum samples and provides accurate results in hours. In addition, the test simultaneously identifies mutations associated with rifampicin resistance, which is a key indicator of multidrug-resistant TB.
The test is intended for patients who screen positive for pulmonary TB and who have either not started anti-TB treatment or who have received less than three days of therapy in the previous six months. The prequalification of tests by WHO is a joint effort by the WHO Global TB Programme and the Department of Regulation and Prequalification to improve access to TB tests that meet WHO’s stringent quality, safety, and performance standards, the organization noted, and to expand global access to high-quality diagnostic options. WHO is currently assessing seven additional TB tests.
