title: Evaluation of Roche Amplicor PCR assay for Mycobacterium tuberculosis.
abstract: The Roche Amplicor Mycobacterium tuberculosis PCR test (RMtb-PCR) was compared with mycobacterial culture, with the BACTEC 460 system and inoculation on Lowenstein-Jensen media. Results were interpreted with an adjusted "gold standard" incorporating clinical diagnosis. A total of 1,480 clinical specimens from 1,155 patients, including tissues and fluids, as well as 141 specimens which demonstrated a positive growth index on the BACTEC 460 system were assessed. The sensitivity, specificity, and positive and negative predictive values of RMtb-PCR compared with the adjusted gold standard for clinical specimens were 79, 99, 93, and 98%, respectively. In smear-positive specimens, the sensitivity of RMtb-PCR was 98% versus 53% for smear-negative specimens. When RMtb-PCR was performed two times per week, PCR results were available an average of 21 days before the culture results. For specimens demonstrating a positive growth index on the BACTEC 460 system, RMtb-PCR had a sensitivity and specificity of 98 and 100%, respectively. This study demonstrates the value of a commercial nucleic acid amplification kit for rapid diagnosis of M. tuberculosis, particularly in smear-positive specimens or BACTEC culture-positive specimens.
authors: University of Toronto, Department of Microbiology, Toronto Hospital, Ontario, Canada.
authors: W L
authors: WL
authors: Wobeser
authors: M
authors: M
authors: Krajden
authors: J
authors: J
authors: Conly
authors: H
authors: H
authors: Simpson
authors: B
authors: B
authors: Yim
authors: M
authors: M
authors: D'costa
authors: M
authors: M
authors: Fuksa
authors: C
authors: C
authors: Hian-Cheong
authors: M
authors: M
authors: Patterson
authors: A
authors: A
authors: Phillips
authors: R
authors: R
authors: Bannatyne
authors: A
authors: A
authors: Haddad
authors: J L
authors: JL
authors: Brunton
authors: S
authors: S
authors: Krajden
mesh_terms: D001431:Bacteriological Techniques / Q000706:statistics & numerical data; D003951:Diagnostic Errors; D005069:Evaluation Studies as Topic; D006801:Humans; D009161:Mycobacterium / Q000235:genetics / Q000254:growth & development / Q000302:isolation & purification; D009164:Mycobacterium Infections / Q000175:diagnosis; D009169:Mycobacterium tuberculosis / Q000235:genetics* / Q000254:growth & development / Q000302:isolation & purification*; D016133:Polymerase Chain Reaction / Q000379:methods* / Q000706:statistics & numerical data; D012680:Sensitivity and Specificity; D013045:Species Specificity; D013997:Time Factors; D014397:Tuberculosis, Pulmonary / Q000175:diagnosis*