EVALUATION OF THE ROCHE AMPLICOR(TM) POLYMERASE CHAIN-REACTION SYSTEMFOR DETECTION OF MYCOBACTERIUM-TUBERCULOSIS COMPLEX IN SPECIMENS

Roche Diagnostic Systems Inc. have recently developed a commercial PCR (Amplicor(TM)) for direct amplification of Mycobacterium tuberculosis Complex (MtbC) from sputum and bronchial washes. Detection of MtbC sp ecific sequence is achieved by hybridization with an oligonucleotide p robe. The aim of this study was to compare the Amplicor(TM) PCR system for detection of MtbC with microscopy, culture and an in-house PCR me thod. The commercial assay correctly identified 35/37 microscopy posit ive specimens compared to 34/37 with the in-house method and 7/13 micr oscopy negative, culture positive samples compared to 2/13 with the in -house procedure, Negative PCR results were obtained for 32 culture ne gative specimens and 6 specimens which yielded mycobacteria other than MtbC, indicating a specificity of 100%. The sensitivity of the commer cial assay was determined to be approximately 10 organisms compared to 100 organisms with the in-house method. The Amplicor(TM) PCR system i s specific, sensitive and easy to perform. It also has the advantages of being standardized and quality controlled.