Use of the INNO LiPA Rif.TB for detection of Mycobacterium tuberculosis DNA directly in clinical specimens and for simultaneous determination of rifampin susceptibility.

The INNO LiPA Rif.TB (Innogenetics, Ghent, Belgium) is a reverse hybridization test developed to detect genetic markers of resistance to rifampin in Mycobacterium tuberculosis complex. In the present study, this test was used directly on 3,763 clinical specimens by adopting a nested amplification of the target. The specificity of the system (98.4%) was optimal, but sensitivity (69.5%) was unsatisfactory. However, when use of the system was limited to smear-positive specimens, the sensitivity rose to 91.7%. As expected, the ability of the system to predict rifampin resistance was not influenced by its direct use on clinical specimens and confirmed the favorable results repeatedly reported in the literature.