Cochrane Database Syst Rev
Xpert Ultra delivers rapid, highly sensitive TB and rifampicin resistance detection
For pulmonary tuberculosis (TB) and rifampicin resistance, Xpert Ultra offers rapid, high-accuracy diagnosis, supporting prompt initiation of appropriate therapy. Its superior sensitivity over previous Xpert versions is most pronounced in smear-negative and HIV-positive populations, though clinicians should interpret trace-positive results cautiously, especially in low-prevalence settings or those with prior TB, to avoid overtreatment.
Study details: This 2025 Cochrane systematic review included 32 studies (12,529 participants) evaluating Xpert MTB/RIF Ultra (Xpert Ultra) for pulmonary TB and 10 studies (1,644 participants) for rifampicin resistance, focusing on adults and adolescents with presumptive TB. Reference standards were culture and phenotypic drug susceptibility testing, with subgroup analyses by smear status, HIV status, and TB history.
Results: Xpert Ultra demonstrated pooled sensitivity of 90.7% (95% confidence interval [CI], 88.2–92.7) and specificity of 94.8% (95% CI, 92.8–96.3) for pulmonary TB detection. Sensitivity was lower in smear-negative/culture-positive cases (80.7%) and in those with prior TB (84.8%), with specificity also reduced in the latter (86.2%). Among people living with HIV, sensitivity was 87.7% and specificity 95.3%. For rifampicin resistance, sensitivity was 95.8% (95% CI, 93.2–97.4) and specificity 98.3% (95% CI, 97.0–99.0). Trace-positive results comprised 38.8% true positives; reclassifying these as negative reduced sensitivity but modestly increased specificity.
Source:
Horne DJ, et al. (2025, July 29). Cochrane Database Syst Rev. Xpert MTB/RIF Ultra assay for pulmonary tuberculosis and rifampicin resistance in adults and adolescents. https://pubmed.ncbi.nlm.nih.gov/40728034/