Automated real-time nucleic acid amplification technology for rapid and simultaneous detection of tuberculosis and rifampicin resistance: Xpert MTB/RIF assay for the diagnosis of pulmonary and extrapulmonary TB in adults and children. Policy update.
Publication year: 2013
The global priorities for tuberculosis (TB) care and control are to improve case-detection and to detect cases earlier, including cases of smear-negative disease which are often associated with coinfection with the human immunodeficiency virus (HIV) and young age, and to enhance the capacity to diagnose multidrug-resistant tuberculosis (MDR-TB). In September 2010, the World Health Organization (WHO) convened an Expert Group to review the evidence on the accuracy of the Xpert MTB/RIF assay (Cepheid, Sunnyvale, CA, United States) for the purpose of formulating recommendations to guide the use of the test. Policy recommendations on using Xpert MTB/RIF were issued by WHO early in 2011, supported by an operational how-to document2 and a checklist for implementation at the country level.
WHO’s current policies and guidance recommend that Xpert MTB/RIF be used as an initial diagnostic test in individuals suspected of having MDR-TB or HIV-associated TB (strong recommendation, moderate quality of evidence). The guidance also provides a conditional recommendation that Xpert MTB/RIF be used as a follow-on test to smear microscopy in settings where MDR-TB or HIV are of lesser concern, especially for further testing of smear-negative specimens. In acknowledgement of the difficulties of obtaining microbiological confirmation of the diagnosis in children, this recommendation generalizes from data on adults to include the use of Xpert MTB/RIF in children.