The World Health Organization has given preliminary compliance assessment to the first molecular test for rapid diagnosis of tuberculosis and assessment of its susceptibility to antibiotics, the organization said in a press release. It is Xpert MTB/RIF Ultra, manufactured by Cepheid and intended 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 recognizes the genetic material of Mycobacterium tuberculosis in sputum samples with high sensitivity and identifies mutations associated with resistance to rifampicin, the main indicator of multidrug resistance in bacteria. The diagnostic process takes about 80 minutes.
