Evaluation of Cobas Amplicor MTB test to detect Mycobacterium tuberculosis in pulmonary and extrapulmonary specimens.

Tuberculosis (TB) is one of the major public health problems in the world. Effective control of TB depends on rapid and correct diagnosis and appropriate treatment. The aim of this study was to evaluate the performance of Cobas Amplicor MTB (CA-MTB) test for pulmonary and extrapulmonary specimens isolated in our laboratory. A total of 424 specimens obtained from the suspected TB patients from January 2003 to August 2004 were included in this study. All specimens (173 pulmonary and 251 extrapulmonary specimens) were processed, stained, cultured and assayed using the CA-MTB test for identification of Mycobacterium tuberculosis. The CA-MTB test results were compared to culture and acid-fast staining as gold standard. The sensitivity, specificity, positive and negative predictive values of CA-MTB were determined as 73%, 100%, 100%, and 97% for pulmonary specimens, and 45%, 100%, 100% and 96% for extrapulmonary specimens respectively. The sensitivity of the test for acid-fast bacilli (AFB) smear positive pulmonary and extrapulmonary specimens was 92% and 75%. These results indicate that the CA-MTB is a rapid test for detection of tuberculosis in pulmonary specimens, but does not perform well enough in extrapulmonary specimens.