Comparison of the GenoType(®) MTBC Molecular Genetic Assay with culture methods in the diagnosis of tuberculosis.

Background: Clinical samples from 433 patients pre-diagnosed with tuberculosis in Konya, Turkey, were investigated prospectively to compare the GenoType(®) MTBC test (GenoType(®) MTBC) with conventional "gold standard" culture methods.

Methods: Lowenstein Jensen (LJ) and Mycobacteria Growth Indicator Tube (MGIT)-960 culture methods and GenoType(®) MTBC were performed together.

Results: Mycobacterium tuberculosis (M. tuberculosis) detection rates were 16.2% by culture methods, 15.4% by GenoType(®) MTBC, and 6% by acid-fast bacilli microscopy. The LJ or MGIT-960 with GenoType(®) MTBC detected M. tuberculosis in 12 samples each that were negative according to the other culture method alone. Among 70 M. tuberculosis-positive samples, detection rates were 37% (26/70) by microscopy and 82.8% (58/70) by LJ and MGIT-960, but 95.7% (67/70) by GenoType(®) MTBC.

Conclusions: GenoType(®) MTBC may be used as a beneficial adjunct test to culture methods for the detection of M. tuberculosis.