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A prospective 2-month trial involving 617 respiratory tract specimens was conducted to compare sensitivity, specificity, and predictive values of the newly developed Gen-Probe Amplified Mycobacterium Tuberculosis Direct Test kit (AMTDT; Gen-Probe, Inc., San Diego, Calif.) for the rapid detection of Mycobacterium tuberculosis and of fluorescent acid-fast staining versus combined BACTEC 12B and solid-medium cultures as the "gold standard." A total of 590 specimens were culture and AMTDT negative. Twenty-one (3.4%) cultures yielded M. tuberculosis. Of these, 15 (71.4%) were detected by AMTDT, whereas 6 (28.6%) were missed. M. tuberculosis did not grow in six (28.6%) of AMTDT-positive specimens derived from three patients under treatment for tuberculosis. AMTDT exhibited a sensitivity, a specificity, a negative predictive value, and a positive predictive value of 71.4, 99, 99, and 71.4%, respectively. In comparison, the same values for fluorescent microscopy were 66.7, 98.3, 98.8, and 58.3%, respectively. AMTDT was easy to perform and highly specific. However, a screening test would require an improved sensitivity and, when feasible, the implementation of an internal amplification control.

journal of clinical microbiology

Screening of respiratory tract specimens for the presence of Mycobacterium tuberculosis by using the Gen-Probe Amplified Mycobacterium Tuberculosis Direct Test