Direct detection of Mycobacterium tuberculosis complex in respiratory specimens by a target-amplified test system.

A total of 938 respiratory specimens (633 sputa, 249 bronchial and tracheal aspirates, and 56 bronchoalveolar lavages) from 589 patients were tested for direct detection of Mycobacterium tuberculosis complex by the Gen-Probe amplified Mycobacterium tuberculosis direct test (MTD), and the results were compared with those of the conventional methods of fluorescence microscopy and cultivation (solid and radiometric media). One series of specimens (n = 515) was decontaminated with N-acetyl-L-cysteine (NALC)-NaOH: the other one (n = 423) was decontaminated with sodium dodecyl (lauryl) sulfate (SDS)-NaOH. Of the specimens decontaminated with NALC, 39 were MTD and culture positive, 455 were MTD and culture negative, 18 were MTD positive and culture negative, and 3 were MTD negative and culture positive, indicating a sensitivity of 92.9% and a specificity of 96.2% for the MTD. Of the specimens decontaminated with SDS, 35 were MTD and culture positive, 372 were MTD and culture negative, 15 were MTD positive and culture negative, and 1 was MTD negative and culture positive, indicating a sensitivity of 97.2% and a specificity of 96.1% for the MTD. After resolution of discrepant results by review of the patients' clinical data, the sensitivity of the MTD was 93.9%, the specificity was 97.6%, the positive predictive value was 80.7%, and the negative predictive value was 99.3% for the NALC series; the corresponding values were 97.4, 96.9, 76.0, and 99.7%, respectively, for the SDS series. In conclusion, the MTD is a highly sensitive and specific technique for detecting M. tuberculosis complex within hours in both smear-positive and smear-negative respiratory specimens.