The World Health Organization has granted preliminary compliance assessment to the first molecular test for rapid tuberculosis diagnosis and antibiotic susceptibility testing, according to a press release from the organization. The test is Xpert MTB/RIF Ultra, manufactured by Cepheid and designed for use in its GeneXpert diagnostic system. The prequalification was based on data provided by the manufacturer and an independent assessment by the Health Sciences Authority of Singapore.
The Xpert MTB/RIF Ultra test is based on nucleic acid amplification. It sensitively recognizes the genetic material of Mycobacterium tuberculosis in sputum samples and identifies mutations associated with resistance to rifampin, the primary indicator of multidrug-resistant bacteria. The diagnostic process takes approximately 80 minutes.
