title: Rapid diagnosis of pulmonary tuberculosis by using Roche AMPLICOR Mycobacterium tuberculosis PCR test.
abstract: A rapid PCR-based test for the diagnosis of pulmonary tuberculosis, the Roche AMPLICOR Mycobacterium tuberculosis test (AMPLICOR MTB), was evaluated. Results from AMPLICOR MTB were compared with culture results and the final clinical diagnosis for each patient. A total of 985 specimens from 372 patients were tested. When AMPLICOR MTB results were compared with resolved results, i.e., a specimen grew M. tuberculosis or was obtained from a patient with a clinical diagnosis of tuberculosis, the sensitivity, specificity, positive predictive value, and negative predictive value for the AMPLICOR MTB test were 66.7, 99.6, 91.7, and 97.7%, respectively. These results were comparable to those obtained from culture. Test results were available approximately 6.5 h after specimen receipt in the laboratory. Our data demonstrate that AMPLICOR MTB will provide rapid, valuable information for the diagnosis and control of tuberculosis.
authors.affiliation: Department of Pathology, Catholic Medical Center of Brooklyn and Queens, Jamaica, New York 11432, USA.
authors.forename: R F
authors.initials: RF
authors.lastname: D'Amato
authors.forename: A A
authors.initials: AA
authors.lastname: Wallman
authors.forename: L H
authors.initials: LH
authors.lastname: Hochstein
authors.forename: P M
authors.initials: PM
authors.lastname: Colaninno
authors.forename: M
authors.initials: M
authors.lastname: Scardamaglia
authors.forename: E
authors.initials: E
authors.lastname: Ardila
authors.forename: M
authors.initials: M
authors.lastname: Ghouri
authors.forename: K
authors.initials: K
authors.lastname: Kim
authors.forename: R C
authors.initials: RC
authors.lastname: Patel
authors.forename: A
authors.initials: A
authors.lastname: Miller
mesh_terms: D001431:Bacteriological Techniques / Q000706:statistics & numerical data; D003951:Diagnostic Errors; D005069:Evaluation Studies as Topic; D006801:Humans; D009169:Mycobacterium tuberculosis / Q000235:genetics* / Q000302:isolation & purification*; D016133:Polymerase Chain Reaction / Q000379:methods* / Q000706:statistics & numerical data; D013997:Time Factors; D014397:Tuberculosis, Pulmonary / Q000175:diagnosis* / Q000382:microbiology