title: Evaluation of the COBAS AMPLICOR MTB test for the detection of Mycobacterium tuberculosis complex.
abstract: We evaluated the COBAS AMPLICOR polymerase chain reaction (PCR) based test for the detection of Mycobacterium tuberculosis complex in 866 respiratory and non-respiratory samples. Acid-fast staining and culture on Lowenstein-Jensen medium were also performed on all samples. Of the 866 samples tested, 87 (10.0%) were PCR-positive compared to 94 (10.9%) culture positive. There were no false positive results but 7 PCR-negative, culture-positive samples were, considered false negatives after reviewing medical records of patients. A PCR inhibitory rate of 2.0% (17/866) was observed in respiratory samples only. Sensitivity, specificity, and positive and negative predictive values for this test were 92.5%, 100%, 100% and 99.1% respectively. This test is a valuable diagnostic tool for today's mycobacteriology laboratory.
authors.affiliation: Molecular Genetics and DNA Diagnostics Laboratory, King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi Arabia.
authors.forename: K K
authors.initials: KK
authors.lastname: Abu-Amero
authors.forename: M A
authors.initials: MA
authors.lastname: Halablab
mesh_terms: D001706:Biopsy; D001992:Bronchoalveolar Lavage Fluid / Q000382:microbiology; D018929:Cell Culture Techniques / Q000379:methods; D002555:Cerebrospinal Fluid / Q000382:microbiology; D004396:Coloring Agents; D004269:DNA, Bacterial / Q000032:analysis / Q000235:genetics*; D005189:False Positive Reactions; D006801:Humans; D009169:Mycobacterium tuberculosis / Q000235:genetics*; D016133:Polymerase Chain Reaction / Q000379:methods* / Q000592:standards; D011237:Predictive Value of Tests; D011446:Prospective Studies; D012529:Saudi Arabia; D012680:Sensitivity and Specificity; D013183:Sputum / Q000382:microbiology; D013997:Time Factors; D014132:Trachea / Q000382:microbiology; D014376:Tuberculosis / Q000175:diagnosis / Q000382:microbiology
chemical_list: D004396:Coloring Agents; D004269:DNA, Bacterial