title: Performance of the Gen-Probe amplified Mycobacterium tuberculosis direct test in a laboratory that infrequently isolates Mycobacterium tuberculosis.
abstract: The performance of the Gen-Probe Mycobacterium tuberculosis direct (MTD) test was assessed in a laboratory whose specimens were derived from a population with a low prevalence (1.3%) of tuberculosis. A total of 339 specimens from 113 patients were included in the study. Nine of 10 MTD positive samples were culture positive (smear positive, n = 7; smear negative, n = 1; smear not ordered, n = 2). The 10th MTD-positive sample, which was smear and culture negative, was from a patient whose two other study specimens were smear and culture positive and who had a clinical history consistent with tuberculosis. Prior to and following resolution of discrepant results, the sensitivities and specificities of the MTD test relative to culture were 100 and 99.7% and 100 and 100%, respectively.
authors.affiliation: Microbiology Laboratories, Massachusetts General Hospital, Boston 02114, USA.
authors.forename: K
authors.initials: K
authors.lastname: Welch
authors.forename: G
authors.initials: G
authors.lastname: Brown
authors.forename: V
authors.initials: V
authors.lastname: Jonas
authors.forename: M J
authors.initials: MJ
authors.lastname: Ferraro
mesh_terms: D001431:Bacteriological Techniques; D005069:Evaluation Studies as Topic; D005188:False Negative Reactions; D005821:Genetic Techniques; D006801:Humans; D009169:Mycobacterium tuberculosis / Q000302:isolation & purification*; D011237:Predictive Value of Tests; D012329:RNA, Bacterial / Q000032:analysis*; D012680:Sensitivity and Specificity; D014376:Tuberculosis / Q000175:diagnosis
chemical_list: D012329:RNA, Bacterial