COMPARISON OF THE ROCHE AMPLICOR MYCOBACTERIUM ASSAY AND DIGENE SHARPSIGNAL SYSTEM WITH IN-HOUSE PCR AND CULTURE FOR DETECTION OF MYCOBACTERIUM-TUBERCULOSIS IN RESPIRATORY SPECIMENS

Two commercial primer kits and detection systems, the Roche AMPLICOR M YCOBACTERIUM test and the Digene primer-probe kit with the SHARP Signa l System, were compared to in-house PCR as well as standard culture te chniques, For the 27 culture-positive specimens, the Roche AMPLICOR MY COBACTERIUM test detected 20 specimens, the Digene system detected 19, and in-house PCR detected 21. Of the 86 culture-negative specimens, 1 3 were positive by the Roche AMPLICOR MYCOBACTERIUM test, 16 were posi tive by the Digene system, and 21 were positive by in-house PCR. When clinical situations were evaluated, 11 of 13 culture-negative Roche AM PLICOR MYCOBACTERIUM test-positive specimens, 10 of 16 culture-negativ e Digene system-positive specimens, and 13 of 21 culture-negative-in-h ouse PCR-positive specimens were diagnosed as true-positive specimens. The sensitivities of Roche AMPLICOR MYCOBACTERIUM test, the Digene sy stem, and in-house PCR were 73.81, 69.05, and 80.95%, and the specific ities were 97.18, 91.55, and 88.73%, respectively. The positive predic tive values were 93.94, 82.86, and 80.95%, and the negative predictive values were 86.25, 83.33, and 88.73%, respectively, For the commercia l kits, the Roche AMPLICOR MYCOBACTERIUM test seems to be more sensiti ve and specific than the Digene system. However, the Roche AMPLICOR MY COBACTERIUM test cannot be used on nonrespiratory specimens.