Evaluation of a commercial rRNA target amplification assay for detection of Mycobacterium tuberculosis complex in respiratory specimens.

Seventy-one respiratory samples were analyzed in a new commercially available target rRNA amplification assay aimed at detecting Mycobacterium tuberculosis complex directly in patient specimens. The assay (Gen-Probe Amplified Mycobacterium Tuberculosis Direct Test) correctly identified 26 of 27 samples positive for Mycobacterium tuberculosis and 43 of 44 samples negative for Mycobacterium tuberculosis in culture. When appropriate controls are performed, the assay also performs well with other specimens, such as tissue biopsies, lymph node or bone marrow aspirates and pleural and ascitic exudates.