| The GRADE process confirmed a solid evidence base to support widespread use of Xpert MTB/RIF for detection of TB and rifampicin resistance and resulted in the following main recommendations: |
| Xpert MTB/RIF should be used as the initial diagnostic test in individuals suspected of having MDR-TB or HIV-associated TB (strong recommendation) |
| Xpert MTB/RIF may be considered as a follow-on test to microscopy in settings where MDR-TB or HIV is of lesser concern, especially in further testing of smear-negative specimens (conditional recommendation, acknowledging major resource implications) |
| Remarks |
| These recommendations apply to the use of Xpert MTB/RIF in sputum specimens (including pellets from decontaminated specimens) |
| Data on the utility of Xpert MTB/RIF in extrapulmonary specimens are still limited |
| These recommendations support the use of one sputum specimen for diagnostic testing, acknowledging that multiple specimens increase the sensitivity of Xpert MTB/RIF but have major resource implications |
| These recommendations also apply to children, based on the generalisation of data from adults and acknowledging the limitations of microbiological diagnosis of TB (including MDR-TB) in children |
| Access to conventional microscopy, culture and DST is still needed for monitoring of therapy, prevalence surveys and/or surveillance and recovering isolates for DST other than rifampicin (including second-line anti-TB drugs) |
GRADE: Grades of Recommendations Assessment, Development and Evaluation; MDR: multidrug resistant; DST: drug susceptibility testing. Data from [6].