Line probe assay for rapid detection of mutations in the rpoB gene of Mycobacterium tuberculosis.

Detection of mutations in the rpoB gene of Mycobacterium tuberculosis has been reported to be an accurate predictor of rifampin resistance. DNA sequence analysis and screening methods such as single-strand conformation polymorphism analysis and dideoxy fingerprinting are labor-intensive, expensive, or yield results that may prove difficult to interpret. We evaluated the accuracy of a commercial line probe assay for rapid identification and characterization of mutations in the rpoB gene in 72 isolates of M. tuberculosis, including 50 rifampin-resistant and 22 rifampin-susceptible strains. Ten distinct rpoB mutations were identified. Concordances with automated sequencing results and phenotypic rifampin susceptibility testing results were 99% and 93%, respectively. The results demonstrate the line probe assay to be a rapid (as short as 1 day) and informative tool for the early detection and characterization of rpoB mutations associated with rifampin resistance in a clinical laboratory setting.